wikidoc - User contributions [en]

Ripretinib

2024-09-12T15:23:13Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=ripretinib |aOrAn=a |drugClass=kinase inhibitor |indicationType=treatment |indication=Gastrointestinal stromal tumor in adults who have been already treated with # or more kinase inhibitors, including imatinib. |adverseReactions=alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting |offLabelAdultGuideSupport=The recommended..."

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=ripretinib
|aOrAn=a
|drugClass=kinase inhibitor
|indicationType=treatment
|indication=Gastrointestinal stromal tumor in adults who have been already treated with # or more kinase inhibitors, including imatinib.
|adverseReactions=alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting
|offLabelAdultGuideSupport=The recommended dosage of ripretinib is 150 mg orally once daily with or without food until disease progression or unacceptable toxicity.

The tablet is swallowed as whole and should be taken on the same time each day. The patients are also advised to take the missed dose earliest if the missed dose is less than 8hrs, and advised to not take additional doses if they develop vomiting.

If they develop any adverse effects, reduce the dosage to 100 mg once daily. However, if they can't tolerate 100 mg, it should be completely discontinued.
}}

Pegunigalsidase alfa-iwxj

2024-05-23T04:38:50Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=pegunigalsidase alfa-iwxj
|aOrAn=a
|drugClass=hydrolytic lysosomal neutral glycosphingolipid-specific enzyme
|indicationType=treatment
|indication=Fabry's disease in adults
|hasBlackBoxWarning=Yes
|adverseReactions=infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
|blackBoxWarningTitle=HYPERSENSITIVITY REACTIONS including Anaphylaxis
|blackBoxWarningBody=Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment.

Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.
|fdaLIADAdult=ELFABRIO is used to treat fabrys disease in adults.

These patients who are treated with ELFABRIO may require pre-treatment with antihistamines, antipyretics, and/or corticosteroids prior to ERT administration. They may require these pre-treatment for 4-6 cycles of ELFABRIO infusion, after which it is step-wise declined or discontinued if ELFABRIO is tolerated.

The recommended dosage of ELFABRIO is based on actual body weight which is 1 mg/kg administered by intravenous infusion every 2 weeks.

The initial recommended ELFABRIO infusion rates for ERT (enzyme replacement therapy)-experienced or ERT-naïve patients are based on actual body weight:
* ˂ 70 kg - total infusion rate=150 mL - infusion volume=0.83 mL/min (50 mL/h)
* 70 -100 kg - total infusion rate=250 mL - infusion volume=1.39 mL/min (83 mL/h)
* > 100 kg - total infusion rate=500 mL - infusion volume=2.78 mL/min (167 mL/h)
The Infusion rate may be increased if the patient tolerates the initial 4-6 infusions and may be slowed in case of a hypersensitivity reaction or an IAR (infusion associated reaction).

Appropriate medical support measures including cardiopulmonary resuscitation equipment should be readily available during ELFABRIO administration.
|warnings=Hypersensitivity Reactions Including Anaphylaxis
In clinical trials, 20 (14%) of ELFABRIO-treated patients experienced hypersensitivity reactions. the reactions included Type I hypersensitivity reaction, hypersensitivity reaction, or bronchospasm which occurred within 5 to 40 minutes of the start of the initial infusion. During thesereaction patients presented with headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema. And these symptoms were treated with antihistamines, epinephrine and systemic corticosteroids.
There it is essential patients should receive pretreatment with antihistamines, antipyretics, and/or corticosteroids prior to ELFABRIO administration.
*If the patient has severe hypersensitivity reaction like anaphylaxis, immediately discontinue ELFABRIO and initiate appropriate medical treatment.
*If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
Furthermore, consider monitoring the presence of IgG and IgE anti-drug antibodies (ADA) in patients who demonstrate hypersensitivity reactions during ELFABRIO treatment.

Infusion-Associated Reactions (IAR)
In clinical trials, 41 (29%) of ELFABRIO-treated patients experienced one or more IARs, defined as any adverse reaction with onset after start of the infusion and up to 24 hours after the end of infusion.
Besides the hypersenstivity reactions, other IAR symptoms include nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension.

Membranoproliferative Glomerulonephritis
Immune deposits in the glomerulus, indicating membraneous glomerulonephritis was observed in the clinical trials. The eventually leading to decline in renal function which slowly improved upon discontinuation of ELFABRIO. Thereofore it is essential to monitor serum creatinine and urinary protein to creatinine ratio.
|FDAPregCat=B
|useInPregnancyFDA=There is no available data on ELFABRIO use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; however, as an enzyme replacement, ELFABRIO is not expected to cause adverse outcomes. Animal reproduction studies have been conducted with pegunigalsidase alfa-iwxj in pregnant rats and rabbits and no adverse effects on embryofetal development were observed in pregnant rats.
|mechAction=ELFABRIO provides an exogenous source of alpha-galactosidase A, which is an enzyme deficient in Fabry's disease. This ELFABRIO is internalized and transported into lysosomes where it is thought to exert enzymatic activity and reduce accumulated globotriaosylceramide (Gb3).
|howSupplied=ELFABRIO (pegunigalsidase alfa-iwxj) injection is a sterile, preservative-free, clear and colorless solution supplied in a single-dose vial. Each vial contains 20 mg/10 mL (2 mg/mL) of pegunigalsidase alfa-iwxj.
ELFABRIO is available as:

*One single-dose vial in a carton
*Five single-dose vials in a carton
*Ten single-dose vials in a carton
|storage=It is stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
|brandNames=ELFABRIO
}}

Pegunigalsidase alfa-iwxj

2024-05-23T02:34:18Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=pegunigalsidase alfa-iwxj
|aOrAn=a
|drugClass=hydrolytic lysosomal neutral glycosphingolipid-specific enzyme
|indicationType=treatment
|indication=Fabry's disease in adults
|hasBlackBoxWarning=Yes
|adverseReactions=infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
|blackBoxWarningTitle=HYPERSENSITIVITY REACTIONS including Anaphylaxis
|blackBoxWarningBody=Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment.

Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.
|fdaLIADAdult=ELFABRIO is used to treat fabrys disease in adults.

These patients who are treated with ELFABRIO may require pre-treatment with antihistamines, antipyretics, and/or corticosteroids prior to ERT administration. They may require these pre-treatment for 4-6 cycles of ELFABRIO infusion, after which it is step-wise declined or discontinued if ELFABRIO is tolerated.

The recommended dosage of ELFABRIO is based on actual body weight which is 1 mg/kg administered by intravenous infusion every 2 weeks.

The initial recommended ELFABRIO infusion rates for ERT (enzyme replacement therapy)-experienced or ERT-naïve patients are based on actual body weight:
* ˂ 70 kg - total infusion rate=150 mL - infusion volume=0.83 mL/min (50 mL/h)
* 70 -100 kg - total infusion rate=250 mL - infusion volume=1.39 mL/min (83 mL/h)
* > 100 kg - total infusion rate=500 mL - infusion volume=2.78 mL/min (167 mL/h)
The Infusion rate may be increased if the patient tolerates the initial 4-6 infusions and may be slowed in case of a hypersensitivity reaction or an IAR (infusion associated reaction).

Appropriate medical support measures including cardiopulmonary resuscitation equipment should be readily available during ELFABRIO administration.
|warnings=Hypersensitivity Reactions Including Anaphylaxis
In clinical trials, 20 (14%) of ELFABRIO-treated patients experienced hypersensitivity reactions. the reactions included Type I hypersensitivity reaction, hypersensitivity reaction, or bronchospasm which occurred within 5 to 40 minutes of the start of the initial infusion. During thesereaction patients presented with headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema. And these symptoms were treated with antihistamines, epinephrine and systemic corticosteroids.
There it is essential patients should receive pretreatment with antihistamines, antipyretics, and/or corticosteroids prior to ELFABRIO administration.
*If the patient has severe hypersensitivity reaction like anaphylaxis, immediately discontinue ELFABRIO and initiate appropriate medical treatment.
*If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
Furthermore, consider monitoring the presence of IgG and IgE ADA in
patients who demonstrate hypersensitivity reactions during ELFABRIO treatment.

Infusion-Associated Reactions (IAR)
In clinical trials, 41 (29%) of ELFABRIO-treated patients experienced one or more IARs, defined as any adverse reaction with onset after start of the infusion and up to 24 hours after the end of infusion.
Besides the hypersenstivity reactions, other IAR symptoms include nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension.

Membranoproliferative Glomerulonephritis
Immune deposits in the glomerulus, indicating membraneous glomerulonephritis was observed in the clinical trials. The eventually leading to decline in renal function which slowly improved upon discontinuation of ELFABRIO. Thereofore it is essential to monitor serum creatinine and urinary protein to creatinine ratio.
|brandNames=ELFABRIO
}}

Pegunigalsidase alfa-iwxj

2024-05-23T02:32:56Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=pegunigalsidase alfa-iwxj
|indicationType=treatment
|indication=Fabry's disease in adults
|hasBlackBoxWarning=Yes
|adverseReactions=infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
|blackBoxWarningTitle=HYPERSENSITIVITY REACTIONS including Anaphylaxis
|blackBoxWarningBody=Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment.

Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.
|fdaLIADAdult=ELFABRIO is used to treat fabrys disease in adults.

These patients who are treated with ELFABRIO may require pre-treatment with antihistamines, antipyretics, and/or corticosteroids prior to ERT administration. They may require these pre-treatment for 4-6 cycles of ELFABRIO infusion, after which it is step-wise declined or discontinued if ELFABRIO is tolerated.

The recommended dosage of ELFABRIO is based on actual body weight which is 1 mg/kg administered by intravenous infusion every 2 weeks.

The initial recommended ELFABRIO infusion rates for ERT (enzyme replacement therapy)-experienced or ERT-naïve patients are based on actual body weight:
* ˂ 70 kg - total infusion rate=150 mL - infusion volume=0.83 mL/min (50 mL/h)
* 70 -100 kg - total infusion rate=250 mL - infusion volume=1.39 mL/min (83 mL/h)
* > 100 kg - total infusion rate=500 mL - infusion volume=2.78 mL/min (167 mL/h)
The Infusion rate may be increased if the patient tolerates the initial 4-6 infusions and may be slowed in case of a hypersensitivity reaction or an IAR (infusion associated reaction).

Appropriate medical support measures including cardiopulmonary resuscitation equipment should be readily available during ELFABRIO administration.
|warnings=Hypersensitivity Reactions Including Anaphylaxis
In clinical trials, 20 (14%) of ELFABRIO-treated patients experienced hypersensitivity reactions. the reactions included Type I hypersensitivity reaction, hypersensitivity reaction, or bronchospasm which occurred within 5 to 40 minutes of the start of the initial infusion. During thesereaction patients presented with headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema. And these symptoms were treated with antihistamines, epinephrine and systemic corticosteroids.
There it is essential patients should receive pretreatment with antihistamines, antipyretics, and/or corticosteroids prior to ELFABRIO administration.
*If the patient has severe hypersensitivity reaction like anaphylaxis, immediately discontinue ELFABRIO and initiate appropriate medical treatment.
*If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
Furthermore, consider monitoring the presence of IgG and IgE ADA in
patients who demonstrate hypersensitivity reactions during ELFABRIO treatment.

Infusion-Associated Reactions (IAR)
In clinical trials, 41 (29%) of ELFABRIO-treated patients experienced one or more IARs, defined as any adverse reaction with onset after start of the infusion and up to 24 hours after the end of infusion.
Besides the hypersenstivity reactions, other IAR symptoms include nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension.

Membranoproliferative Glomerulonephritis
Immune deposits in the glomerulus, indicating membraneous glomerulonephritis was observed in the clinical trials. The eventually leading to decline in renal function which slowly improved upon discontinuation of ELFABRIO. Thereofore it is essential to monitor serum creatinine and urinary protein to creatinine ratio.
|brandNames=ELFABRIO
}}

Pegunigalsidase alfa-iwxj

2024-05-23T02:18:51Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=pegunigalsidase alfa-iwxj
|indicationType=treatment
|indication=Fabry's disease in adults
|hasBlackBoxWarning=Yes
|adverseReactions=infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
|blackBoxWarningTitle=HYPERSENSITIVITY REACTIONS including Anaphylaxis
|blackBoxWarningBody=Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment.

Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.
|fdaLIADAdult=ELFABRIO is used to treat fabrys disease in adults.

These patients who are treated with ELFABRIO may require pre-treatment with antihistamines, antipyretics, and/or corticosteroids prior to ERT administration. They may require these pre-treatment for 4-6 cycles of ELFABRIO infusion, after which it is step-wise declined or discontinued if ELFABRIO is tolerated.

The recommended dosage of ELFABRIO is based on actual body weight which is 1 mg/kg administered by intravenous infusion every 2 weeks.

The initial recommended ELFABRIO infusion rates for ERT (enzyme replacement therapy)-experienced or ERT-naïve patients are based on actual body weight:
* ˂ 70 kg - total infusion rate=150 mL - infusion volume=0.83 mL/min (50 mL/h)
* 70 -100 kg - total infusion rate=250 mL - infusion volume=1.39 mL/min (83 mL/h)
* > 100 kg - total infusion rate=500 mL - infusion volume=2.78 mL/min (167 mL/h)
The Infusion rate may be increased if the patient tolerates the initial 4-6 infusions and may be slowed in case of a hypersensitivity reaction or an IAR (infusion associated reaction).

Appropriate medical support measures including cardiopulmonary resuscitation equipment should be readily available during ELFABRIO administration.
|warnings=Hypersensitivity Reactions Including Anaphylaxis
In clinical trials, 20 (14%) of ELFABRIO-treated patients experienced hypersensitivity reactions. the reactions included Type I hypersensitivity reaction, hypersensitivity reaction, or bronchospasm which occurred within 5 to 40 minutes of the start of the initial infusion. During thesereaction patients presented with headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema. And these symptoms were treated with antihistamines, epinephrine and systemic corticosteroids.
There it is essential patients should receive pretreatment with antihistamines, antipyretics, and/or corticosteroids prior to ELFABRIO administration.
*If the patient has severe hypersensitivity reaction like anaphylaxis, immediately discontinue ELFABRIO and initiate appropriate medical treatment.
*If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
Furthermore, consider monitoring the presence of IgG and IgE ADA in
patients who demonstrate hypersensitivity reactions during ELFABRIO treatment.

Infusion-Associated Reactions

Membranoproliferative Glomerulonephritis
|brandNames=ELFABRIO
}}

Pegunigalsidase alfa-iwxj

2024-05-22T04:26:40Z

Alen Antony:

Pegunigalsidase alfa-iwxj

2024-05-22T04:06:59Z

Alen Antony:

Pegunigalsidase alfa-iwxj

2024-05-22T03:57:18Z

Alen Antony:

Pegunigalsidase alfa-iwxj

2024-05-21T21:25:27Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=pegunigalsidase alfa-iwxj |indicationType=treatment |indication=Fabry's disease in adults |hasBlackBoxWarning=Yes |adverseReactions=infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis. |blackBoxWarningTitle=HYPERSENSITIVITY REACTIONS including Anaphylaxis |blackBoxWarningBody=Patients may experience hypersensitivity reaction including a..."

Leniolisib

2024-05-20T03:56:16Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=leniolisib
|aOrAn=a
|drugClass=kinase inhibitor
|indicationType=treatment
|indication=activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
|adverseReactions=headache, sinusitis, and [[atopic dermatitis]].
|fdaLIADAdult=JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

The recommended dosage of JOENJA in adult and pediatric patients of 12 years age and older weighing 45 kg or greater is 70 mg which is administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.

The patient is advised to take the next dose as per the usual schedule if the missed dose has been more than 6 hours.
They are also advised to take next dose as soon as possible if vomiting occurs within 1 hour after taking JOENJA, However, wait and take the next scheduled dos if it's been more than 1 hour.
|contraindications=none
|warnings=* Embryo fetal toxicity
It is essential to verify the pregnancy status prior to starting JOENJA treatment as it carries potential risk to developing fetus.

It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients.
Therefor, reproductive women are advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.

* Vaccinations
Live, attenuated vaccinations may be less effective if administered during JOENJA treatment.
|clinicalTrials=In a 12-week, placebo-controlled portion of Study 2201 in which either JOENJA 70 mg (N=21) or placebo (N=10) was administered twice daily to patients with APDS, a greater incidence of adverse effects were observed in patients receiving JOENJA compared to placebo.
The most common adverse effects were headache (24%), sinusitis (19%), and atopic dermatitis (14%).
Others were Tachycardia (10%), Diarrhea (10%), Fatigue (10%), Pyrexia (10%), Back pain (10%), Neck pain (10%), and Alopecia (10%).
|drugInteractions=*JOENJA is a substrate of CYP3A4. Leniolisib exposure was increased 2-fold when co-administered with a strong CYP3A4 inhibitor like itraconazole. Concomitant use of JOENJA with strong CYP3A4 inhibitors should be avoided.

* Concomitant use of JOENJA with strong and moderate CYP3A4 inducers should be avoided because concomitant use of strong and moderate CYP3A4 inducers may result in reduced leniolisib exposure and thus reduced leniolisib efficacy.

* Avoid concomitant use of JOENJA with drugs that are primarily metabolized by isoenzyme CYP1A2 and have a narrow therapeutic index, as Leniolisib inhibits CYP1A2 in a time-dependent manner in vitro.
|FDAPregCat=C
|useInPregnancyFDA=There is no sufficient data regarding usage of JOENJA in pregnant women.

JOENJA can cause fetal harm based on findings from animal studies. It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients.
Therefor, reproductive women are advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.
|useInPed=The safety and effectiveness of JOENJA for the treatment of activated phosphoinositide 3-kinase delta syndrome have been established in pediatric patients 12 years of age and older but not below 12years.
|useInHepaticImpair=Leniolisib is extensively (60%) metabolized by the liver. Hence, the use of JOENJA is not recommended in moderate to severe haptic impairment.
|useInReproPotential=JOENJA may cause fetal harm when administered to a pregnant woman based on animal studies.
Therefor it is essential to run pregnancy screening for reproductive potential females prior to initiating JOENJA and pregnant mothers should be advised about the potential harm to developing fetus while on JOENJA.

Females are advised to follow contraception during the treatment course of JOENJA.
|administration=JOENJA is available as 70mg tablets administered orally.

The recommended dosage in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.
|monitoring=Advise patients that if vomiting occurs within 1 hour after taking JOENJA, take JOENJA as soon as possible. If vomiting occurs more than 1 hour after dosing, wait and take the next dose at the usual time.
|mechAction=Leniolisib is a kinase inhibitors which inhibits PI3K-delta by blocking the active binding site of PI3K-delta.

Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/Akt pathway, and to the dysregulation of B and T cells.
|PK=*leniolisib median time to maximum plasma concentration (Tmax) occurred at about 1 hour postdose.

*The apparent terminal elimination t1/2 is approximately 10 hours. The volume of distribution of leniolisib is estimated to be 28.5 L in patients with APDS and was highly bound (94.5%) to plasma proteins.

*The mean recovery of total 14C-radioactivity following a single oral dose of 70 mg 14C-leniolisib was 92.5% (67.0% and 25.5% recovered via feces and urine, respectively) 168 hours postdose.

*60% of leniolisib is metabolized by the liver, with CYP3A4 being the most predominant enzyme involved (95.4%) in the primary oxidative metabolism of leniolisib with minor contribution from other enzymes (3.5% CYP3A5, 0.7% CYP1A2 and 0.4% CYP2D6).
|howSupplied=JOENJA is available in 70 mg tablet which is a yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with "70" on one side and "LNB" on the other side. It is supplied in bottles with a child-resistant cap of 60 tablets.
|storage=Its stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) and should not be refrigerated.
|brandNames=JOENJA
}}

Leniolisib

2024-05-20T03:38:57Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=leniolisib
|aOrAn=a
|drugClass=kinase inhibitor
|indicationType=treatment
|indication=activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
|adverseReactions=headache, sinusitis, and [[atopic dermatitis]].
|fdaLIADAdult=JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

The recommended dosage of JOENJA in adult and pediatric patients of 12 years age and older weighing 45 kg or greater is 70 mg which is administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.

The patient is advised to take the next dose as per the usual schedule if the missed dose has been more than 6 hours.
They are also advised to take next dose as soon as possible if vomiting occurs within 1 hour after taking JOENJA, However, wait and take the next scheduled dos if it's been more than 1 hour.
|contraindications=none
|warnings=* Embryo fetal toxicity
It is essential to verify the pregnancy status prior to starting JOENJA treatment as it carries potential risk to developing fetus.

It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients.
Therefor, reproductive women are advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.

* Vaccinations
Live, attenuated vaccinations may be less effective if administered during JOENJA treatment.
|clinicalTrials=In a 12-week, placebo-controlled portion of Study 2201 in which either JOENJA 70 mg (N=21) or placebo (N=10) was administered twice daily to patients with APDS, a greater incidence of adverse effects were observed in patients receiving JOENJA compared to placebo.
The most common adverse effects were headache (24%), sinusitis (19%), and atopic dermatitis (14%).
Others were Tachycardia (10%), Diarrhea (10%), Fatigue (10%), Pyrexia (10%), Back pain (10%), Neck pain (10%), and Alopecia (10%).
|drugInteractions=*JOENJA is a substrate of CYP3A4. Leniolisib exposure was increased 2-fold when co-administered with a strong CYP3A4 inhibitor like itraconazole. Concomitant use of JOENJA with strong CYP3A4 inhibitors should be avoided.

* Concomitant use of JOENJA with strong and moderate CYP3A4 inducers should be avoided because concomitant use of strong and moderate CYP3A4 inducers may result in reduced leniolisib exposure and thus reduced leniolisib efficacy.

* Avoid concomitant use of JOENJA with drugs that are primarily metabolized by isoenzyme CYP1A2 and have a narrow therapeutic index, as Leniolisib inhibits CYP1A2 in a time-dependent manner in vitro.
|FDAPregCat=C
|useInPregnancyFDA=There is no sufficient data regarding usage of JOENJA in pregnant women.

JOENJA can cause fetal harm based on findings from animal studies. It was observed during the clinical studies that when JOENJA was administered to rats and rabbits during the period of organogenesis. JOENJA caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients.
Therefor, reproductive women are advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.
|useInPed=The safety and effectiveness of JOENJA for the treatment of activated phosphoinositide 3-kinase delta syndrome have been established in pediatric patients 12 years of age and older but not below 12years.
|useInHepaticImpair=Leniolisib is extensively (60%) metabolized by the liver. Hence, the use of JOENJA is not recommended in moderate to severe haptic impairment.
|useInReproPotential=JOENJA may cause fetal harm when administered to a pregnant woman based on animal studies.
Therefor it is essential to run pregnancy screening for reproductive potential females prior to initiating JOENJA and pregnant mothers should be advised about the potential harm to developing fetus while on JOENJA.

Females are advised to follow contraception during the treatment course of JOENJA.
|mechAction=Leniolisib is a kinase inhibitors which inhibits PI3K-delta by blocking the active binding site of PI3K-delta.

Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/Akt pathway, and to the dysregulation of B and T cells.
|brandNames=JOENJA
}}

Leniolisib

2024-05-17T20:01:04Z

Alen Antony:

Leniolisib

2024-05-17T19:37:52Z

Alen Antony:

Leniolisib

2024-05-17T19:36:29Z

Alen Antony:

Leniolisib

2024-05-17T18:56:08Z

Alen Antony:

Leniolisib

2024-05-16T14:41:31Z

Alen Antony:

Leniolisib

2024-05-16T14:40:51Z

Alen Antony:

Leniolisib

2024-05-16T14:40:26Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=leniolisib |aOrAn=a |drugClass=kinase inhibitor |indicationType=treatment |indication=activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. |adverseReactions=headache, sinusitis, and {{atopic dermatitis}}. |brandNames=JOENJA }}"

Trofinetide

2024-05-16T14:34:12Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=trofinetide
|aOrAn=a
|drugClass=drug
|indicationType=treatment
|indication=Rett syndrome in adults and pediatric patients of age 2 years and older
|adverseReactions=diarrhea and vomiting.
|fdaLIADAdult=DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

DAYBUE is administered orally or via gastrostomy tube twice daily, in the morning and evening, according to patient weight and can be taken with or without food.
**9-12 kg - 5000 mg twice daily (25ml twice daily)
**12-20 kg - 6000 mg twice daily (30ml twice daily)
**20-35 kg - 8000 mg twice daily (40ml twice daily)
**35-50 kg - 10000 mg twice daily (50ml twice daily)
**50 kg or more - 12,000 mg twice daily (60 mL twice daily)

If a dose of DAYBUE is missed, the next dose should be taken as scheduled and doses should not be doubled.

An additional dose should not be taken if vomiting occurs after DAYBUE administration and instead, continue with the next scheduled dose.

Patients are advised to discontinue laxatives prior to starting DAYBUE. The DAYBUE dosage is interrupted or reduced if patients develops severe diarrhea, dehydration or significant weight loss.
|contraindications=none
|warnings=1. Diarrhea
In a clinical study, it was observed 85% of patients treated with DAYBUE experienced diarrhea and in those, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy.

Patients are advised to discontinue any laxatives prior to starting DAYBUE.
Healthcare providers are informed and appropriate management with antidiarrheal agents and fluids are initiated if the patients develop diarrhea during the DAYBUE treatment course. Interrupt, reduce dose, or discontinue DAYBUE, if severe diarrhea occurs or if dehydration is suspected.

2. Weight loss
In a clinical study, 12% of patients on DAYBUE developed weight loss greater than 7% from the baseline compared to the 4% of the placebo.

Patients are advised to monitor their weight during the treatment course and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
|clinicalTrials=A randomized, double-blind, placebo-controlled, 12-week study of patients with Rett syndrome was performed to evaluate the safety of the drug.
The study consisted of 93 patients receiving DAYBUE and other 94 patients receiving placebo, among which all were female with 92% white and age ranging from 5to 20 years.

The results showed at least 5% of patients treated with DAYBUE had adverse effects and was 2% more frequent than the patients treated with placebo.
Among which the most common adverse effects were diarrhea (82%) and vomiting (29%). Others were Fever (9%), Seizure (9%), anxiety (8%), decreased appetite (8%), fatigue (8%), and nasopharyngitis (5%).
|drugInteractions=Trofinetide is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE.
Hence, patients are closely monitored when DAYBUE is used along with orally administered CYP3A4 sensitive substrates.
|FDAPregCat=B
|useInPregnancyFDA=No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically.

No sufficient data is available regarding the developmental risk associated with the DAYBUE usage in pregnant women.
|useInNursing=There is no data regarding the presence of trofinetide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of DAYBUE for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
|useInGeri=Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients.
|administration=DAYBUE is administered orally or via gastrostomy tube as a solution, and tge recommended dosage is determined as per the weight of the body.

DAYBUE is administered twice daily, in the morning and evening, according to patient weight and can be taken with or without food.
|monitoring=Monitor the patient for diarrhea, vomiting, dehydration or significat weight loss during the treatment course with DAYBUE.

The DAYBUE dosage is interrupted, reduced or discontinued if they develop severe diarrhea, dehydration or significant weight loss.
|mechAction=The exact mechanism of action through which DAYBUE produced its therapeutic effects on Rett syndrome is unknown.
|structure=Trofinetide is designated chemically as (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). Its empirical formula is C13H21N3O6 and its molecular weight is 315.33 g/mol.
|PK=*The time to attain maximum drug concentration (Tmax) is about 2 to 3 hours after administration.
Coadministration of DAYBUE with a high-fat meal had no impact on the total exposure (AUC0-inf) of trofinetide and reduced the peak plasma concentration (Cmax) by approximately 20%.

*Following oral administration, the apparent volume of distribution of trofinetide in healthy adult subjects was approximately 80 L and the protein binding in human plasma is less than 6%.

*The effective elimination half-life of orally administered trofinetide in healthy subjects is about 1.5 hours.

*Trofinetide is not significantly metabolized by CYP450 enzymes.

*Trofinetide is primarily excreted unchanged (approximately 80% of the dose) in urine, with minor excretion in feces.
|howSupplied=Trofinetide (DAYBUE) is available as an oral solution 200 mg/mL of a pink to red, strawberry flavored solution.

It is upplied in a nominal 500 mL round high-density polyethylene (HDPE) multi-dose bottle with a child-resistant closure containing 450 mL of oral solution
|storage=Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F)and do not freeze.

Discard any unused DAYBUE oral solution after 14 days of first opening the bottle.
|brandNames=DAYBUE
}}

Trofinetide

2024-05-16T14:19:52Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=trofinetide
|aOrAn=a
|drugClass=drug
|indicationType=treatment
|indication=Rett syndrome in adults and pediatric patients of age 2 years and older
|adverseReactions=diarrhea and vomiting.
|fdaLIADAdult=DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

DAYBUE is administered orally or via gastrostomy tube twice daily, in the morning and evening, according to patient weight and can be taken with or without food.
**9-12 kg - 5000 mg twice daily (25ml twice daily)
**12-20 kg - 6000 mg twice daily (30ml twice daily)
**20-35 kg - 8000 mg twice daily (40ml twice daily)
**35-50 kg - 10000 mg twice daily (50ml twice daily)
**50 kg or more - 12,000 mg twice daily (60 mL twice daily)

If a dose of DAYBUE is missed, the next dose should be taken as scheduled and doses should not be doubled.

An additional dose should not be taken if vomiting occurs after DAYBUE administration and instead, continue with the next scheduled dose.

Patients are advised to discontinue laxatives prior to starting DAYBUE. The DAYBUE dosage is interrupted or reduced if patients develops severe diarrhea, dehydration or significant weight loss.
|contraindications=none
|warnings=1. Diarrhea
In a clinical study, it was observed 85% of patients treated with DAYBUE experienced diarrhea and in those, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy.

Patients are advised to discontinue any laxatives prior to starting DAYBUE.
Healthcare providers are informed and appropriate management with antidiarrheal agents and fluids are initiated if the patients develop diarrhea during the DAYBUE treatment course. Interrupt, reduce dose, or discontinue DAYBUE, if severe diarrhea occurs or if dehydration is suspected.

2. Weight loss
In a clinical study, 12% of patients on DAYBUE developed weight loss greater than 7% from the baseline compared to the 4% of the placebo.

Patients are advised to monitor their weight during the treatment course and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
|clinicalTrials=A randomized, double-blind, placebo-controlled, 12-week study of patients with Rett syndrome was performed to evaluate the safety of the drug.
The study consisted of 93 patients receiving DAYBUE and other 94 patients receiving placebo, among which all were female with 92% white and age ranging from 5to 20 years.

The results showed at least 5% of patients treated with DAYBUE had adverse effects and was 2% more frequent than the patients treated with placebo.
Among which the most common adverse effects were diarrhea (82%) and vomiting (29%). Others were Fever (9%), Seizure (9%), anxiety (8%), decreased appetite (8%), fatigue (8%), and nasopharyngitis (5%).
|drugInteractions=Trofinetide is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE.
Hence, patients are closely monitored when DAYBUE is used along with orally administered CYP3A4 sensitive substrates.
|FDAPregCat=B
|useInPregnancyFDA=No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically.

No sufficient data is available regarding the developmental risk associated with the DAYBUE usage in pregnant women.
|useInNursing=There is no data regarding the presence of trofinetide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of DAYBUE for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
|useInGeri=Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients.
|mechAction=The exact mechanism of action through which DAYBUE produced its therapeutic effects on Rett syndrome is unknown.
|structure=Trofinetide is designated chemically as (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). Its empirical formula is C13H21N3O6 and its molecular weight is 315.33 g/mol.
|brandNames=DAYBUE
}}

Trofinetide

2024-05-16T03:47:31Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=trofinetide
|aOrAn=a
|drugClass=drug
|indicationType=treatment
|indication=Rett syndrome in adults and pediatric patients of age 2 years and older
|adverseReactions=diarrhea and vomiting.
|fdaLIADAdult=DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

DAYBUE is administered orally or via gastrostomy tube twice daily, in the morning and evening, according to patient weight and can be taken with or without food.

**9-12 kg - 5000 mg twice daily (25ml twice daily)
**12-20 kg - 6000 mg twice daily (30ml twice daily)
**20-35 kg - 8000 mg twice daily (40ml twice daily)
**35-50 kg - 10000 mg twice daily (50ml twice daily)
**50 kg or more - 12,000 mg twice daily (60 mL twice daily)

If a dose of DAYBUE is missed, the next dose should be taken as scheduled and doses should not be doubled.

An additional dose should not be taken if vomiting occurs after DAYBUE administration and instead, continue with the next scheduled dose.

Patients are advised to discontinue laxatives prior to starting DAYBUE. The DAYBUE dosage is interrupted or reduced if patients develops severe diarrhea, dehydration or significant weight loss.
|contraindications=none
|warnings=1. Diarrhea
In a clinical study, it was observed 85% of patients treated with DAYBUE experienced diarrhea and in those, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy.

Patients are advised to discontinue any laxatives prior to starting DAYBUE.
Healthcare providers are informed and appropriate management with antidiarrheal agents and fluids are initiated if the patients develop diarrhea during the DAYBUE treatment course. Interrupt, reduce dose, or discontinue DAYBUE, if severe diarrhea occurs or if dehydration is suspected.

2. Weight loss
In a clinical study, 12% of patients on DAYBUE developed weight loss greater than 7% from the baseline compared to the 4% of the placebo.

Patients are advised to monitor their weight during the treatment course and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
|clinicalTrials=A randomized, double-blind, placebo-controlled, 12-week study of patients with Rett syndrome was performed to evaluate the safety of the drug.
The study consisted of 93 patients receiving DAYBUE and other 94 patients receiving placebo, among which all were female with 92% white and age ranging from 5to 20 years.

The results showed at least 5% of patients treated with DAYBUE had adverse effects and was 2% more frequent than the patients treated with placebo.
Among which the most common adverse effects were diarrhea (82%) and vomiting (29%). Others were Fever (9%), Seizure (9%), anxiety (8%), decreased appetite (8%), fatigue (8%), and nasopharyngitis (5%).
|drugInteractions=Trofinetide is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE.
Hence, patients are closely monitored when DAYBUE is used along with orally administered CYP3A4 sensitive substrates.
|FDAPregCat=B
|useInPregnancyFDA=No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically.

No sufficient data is available regarding the developmental risk associated with the DAYBUE usage in pregnant women.
|useInNursing=There is no data regarding the presence of trofinetide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of DAYBUE for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
|useInGeri=Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients.
|mechAction=The exact mechanism of action through which DAYBUE produced its therapeutic effects on Rett syndrome is unknown.
|structure=Trofinetide is designated chemically as (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). Its empirical formula is C13H21N3O6 and its molecular weight is 315.33 g/mol.
|brandNames=DAYBUE
}}

Trofinetide

2024-05-16T03:46:58Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=trofinetide
|aOrAn=a
|drugClass=drug
|indicationType=treatment
|indication=Rett syndrome in adults and pediatric patients of age 2 years and older
|adverseReactions=diarrhea and vomiting.
|fdaLIADAdult=DAYBUE (trofinetide) is used for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

DAYBUE is administered orally or via gastrostomy tube twice daily, in the morning and evening, according to patient weight and can be taken with or without food.
**9-12 kg - 5000 mg twice daily (25ml twice daily)
**12-20 kg - 6000 mg twice daily (30ml twice daily)
**20-35 kg - 8000 mg twice daily (40ml twice daily)
**35-50 kg - 10000 mg twice daily (50ml twice daily)
**50 kg or more - 12,000 mg twice daily (60 mL twice daily)

If a dose of DAYBUE is missed, the next dose should be taken as scheduled and doses should not be doubled.

An additional dose should not be taken if vomiting occurs after DAYBUE administration and instead, continue with the next scheduled dose.

Patients are advised to discontinue laxatives prior to starting DAYBUE. The DAYBUE dosage is interrupted or reduced if patients develops severe diarrhea, dehydration or significant weight loss.
|contraindications=none
|warnings=1. Diarrhea
In a clinical study, it was observed 85% of patients treated with DAYBUE experienced diarrhea and in those, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy.

Patients are advised to discontinue any laxatives prior to starting DAYBUE.
Healthcare providers are informed and appropriate management with antidiarrheal agents and fluids are initiated if the patients develop diarrhea during the DAYBUE treatment course. Interrupt, reduce dose, or discontinue DAYBUE, if severe diarrhea occurs or if dehydration is suspected.

2. Weight loss
In a clinical study, 12% of patients on DAYBUE developed weight loss greater than 7% from the baseline compared to the 4% of the placebo.

Patients are advised to monitor their weight during the treatment course and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.
|clinicalTrials=A randomized, double-blind, placebo-controlled, 12-week study of patients with Rett syndrome was performed to evaluate the safety of the drug.
The study consisted of 93 patients receiving DAYBUE and other 94 patients receiving placebo, among which all were female with 92% white and age ranging from 5to 20 years.

The results showed at least 5% of patients treated with DAYBUE had adverse effects and was 2% more frequent than the patients treated with placebo.
Among which the most common adverse effects were diarrhea (82%) and vomiting (29%). Others were Fever (9%), Seizure (9%), anxiety (8%), decreased appetite (8%), fatigue (8%), and nasopharyngitis (5%).
|drugInteractions=Trofinetide is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE.
Hence, patients are closely monitored when DAYBUE is used along with orally administered CYP3A4 sensitive substrates.
|FDAPregCat=B
|useInPregnancyFDA=No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically.

No sufficient data is available regarding the developmental risk associated with the DAYBUE usage in pregnant women.
|useInNursing=There is no data regarding the presence of trofinetide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of DAYBUE for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older.
|useInGeri=Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients.
|mechAction=The exact mechanism of action through which DAYBUE produced its therapeutic effects on Rett syndrome is unknown.
|structure=Trofinetide is designated chemically as (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). Its empirical formula is C13H21N3O6 and its molecular weight is 315.33 g/mol.
|brandNames=DAYBUE
}}

Trofinetide

2024-05-16T03:29:20Z

Alen Antony:

Trofinetide

2024-05-16T03:09:12Z

Alen Antony:

Trofinetide

2024-05-15T04:40:56Z

Alen Antony:

Trofinetide

2024-05-15T04:40:14Z

Alen Antony:

Fezolinetant

2024-05-15T04:28:41Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|OTC=Yes
|genericName=fezolinetant
|aOrAn=a
|drugClass=neurokinin 3 (NK3) receptor antagonist
|indicationType=treatment
|indication=moderate to severe vasomotor symptoms due to menopause.
|adverseReactions=abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
|fdaLIADAdult=Fezolinetant is used to treat moderate and severe vasomotor symptoms due to menopause.

The recommended dosage is 45 mg administered orally as a tablet, once daily with or without meal. Always perform blood work to evaluate for hepatic impairment/failure prior to initiation of the treatment and follow up with blood workup every 3 months, 6 months and 9 months after initiating the therapy.
|contraindications=*Known history of cirrhosis

*Known history of Severe renal impairment or end-stage renal disease

*Concomitant use with CYP1A2 inhibitors
|warnings=Elevation of Hepatic transaminases

In three clinical trials, there has been elevation of transaminases three times the upper limit observed in 2.3% [exposure adjusted incidence rate (EAIR) of 2.7 per 100 person-years] of women receiving VEOZAH and 0.9% (EAIR of 1.5 per 100 person-years) women receiving placebo.

Do not start VEOZAH if concentration of ALT or AST is equal to or exceeds two times the Upper limit or if the total bilirubin is elevated which is equal to or exceeds two times the upper normal limit for the evaluating laboratory.

Evaluate the serum AST ALT and bilirubin level at 3 months, 6 months, and 9 months after initiating the therapy and also when the patient develops symptoms of hepatic injury (like nausea, vomiting, or yellowing of the skin or eyes).
|clinicalTrials=In a double blinded 52-week trial, 602 women were taking VEOZAH 45mg and 610 received placebo and at least 2% were reported in VEOZAH 45mg and greater than placebo.

Among which the adverse effects were Abdominal pain was 4.3%, Diarrhea was 3.9%, Insomnia was 3.9%, Back pain was 3.0%, Hot flush 2.5% and Hepatic transaminase elevation was 2.3%.
|drugInteractions=VEOZAH is contraindicated in individuals using CYP1A2 inhibitors because concomitant use of VEOZAH with drugs that are weak, moderate, or strong CYP1A2 inhibitors, increase the plasma concentration of VEOZAH.
|useInPregnancyFDA=no data on VEOZAH use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
|useInRenalImpair=VEOZAH is contraindicated in individuals with severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2) .

Dosage adjustment is not required for mild and moderate renal impairement.
|useInHepaticImpair=Child-Pugh Class A or B hepatic impairment increased the exposure of VEOZAH, however VEOZAH has not been studied in individuals with Child-Pugh Class C hepatic impairment.

VEOZAH is contraindicated in individuals with cirrhosis
|administration=VEOZAH (fezolinetant) is administered orally once daily as a single tablet of 45 mg with or without meal.

If a dose of VEOZAH is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose and return to the regular schedule the following day.
|monitoring=Serum AST, ALT and Bilirubin should be evaluated prior to initiating this medication to evaluate for hepatic injury/failure.

During the treatment phase using VEOZAH, follow-up bloodwork is performed at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms (such as nausea, vomiting, or yellowing of the skin or eyes) suggest liver injury.
|mechAction=VEOZAH is a neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center.
|structure=The chemical name of fezolinetant is (4-Fluorophenyl)[(8R)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]methanone having a molecular formula of C16H15FN6OS and a molecular weight of 358.39.
|PD=Transient decrease of luteinizing hormone (LH) levels was observed at peak concentrations of fezolinetant.
|PK=*The median (range) time to reach fezolinetant Cmax is 1.5 (1 to 4) hours in healthy women.

No clinically significant differences in fezolinetant pharmacokinetics were observed following administration with a high-calorie, high-fat meal containing approximately 1000 calories

*The mean apparent volume of distribution of fezolinetant is 189 L. The plasma protein binding of fezolinetant is 51% and the blood-to-plasma ratio is 0.9.

*The effective half-life (t1/2) of fezolinetant is 9.6 hours in women with vasomotor symptoms.

*Fezolinetant is primarily metabolized by CYP1A2 and to a lesser extent by CYP2C9 and CYP2C19 with the major metabolite ES259564, is identified in plasma and is approximately 20-fold less potent than the parent.

*76.9% of the dose was excreted in urine (1.1% unchanged) and 14.7% in feces (0.1% unchanged) following oral administration of fezolinetant.
|howSupplied=VEOZAH (fezolinetant) 45 mg tablets are supplied as round, light red, film-coated tablets, debossed with the Astellas logo and ‘645’ on the same side.

VEOZAH tablets are available in the following package sizes:
*Bottles of 30 tablets with child resistant closure and desiccant
*Bottles of 90 tablets with child resistant closure and desiccant
|storage=Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F)
|brandNames=VEOZAH
}}

Fezolinetant

2024-05-15T04:21:07Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|OTC=Yes
|genericName=fezolinetant
|aOrAn=a
|drugClass=neurokinin 3 (NK3) receptor antagonist
|indicationType=treatment
|indication=moderate to severe vasomotor symptoms due to menopause.
|adverseReactions=abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
|fdaLIADAdult=Fezolinetant is used to treat moderate and severe vasomotor symptoms due to menopause.

The recommended dosage is 45 mg administered orally as a tablet, once daily with or without meal. Always perform blood work to evaluate for hepatic impairment/failure prior to initiation of the treatment and follow up with blood workup every 3 months, 6 months and 9 months after initiating the therapy.
|contraindications=*Known history of cirrhosis

*Known history of Severe renal impairment or end-stage renal disease

*Concomitant use with CYP1A2 inhibitors
|warnings=Elevation of Hepatic transaminases

In three clinical trials, there has been elevation of transaminases three times the upper limit observed in 2.3% [exposure adjusted incidence rate (EAIR) of 2.7 per 100 person-years] of women receiving VEOZAH and 0.9% (EAIR of 1.5 per 100 person-years) women receiving placebo.

Do not start VEOZAH if concentration of ALT or AST is equal to or exceeds two times the Upper limit or if the total bilirubin is elevated which is equal to or exceeds two times the upper normal limit for the evaluating laboratory.

Evaluate the serum AST ALT and bilirubin level at 3 months, 6 months, and 9 months after initiating the therapy and also when the patient develops symptoms of hepatic injury (like nausea, vomiting, or yellowing of the skin or eyes).
|clinicalTrials=In a double blinded 52-week trial, 602 women were taking VEOZAH 45mg and 610 received placebo and at least 2% were reported in VEOZAH 45mg and greater than placebo.

Among which the adverse effects were Abdominal pain was 4.3%, Diarrhea was 3.9%, Insomnia was 3.9%, Back pain was 3.0%, Hot flush 2.5% and Hepatic transaminase elevation was 2.3%.
|drugInteractions=VEOZAH is contraindicated in individuals using CYP1A2 inhibitors because concomitant use of VEOZAH with drugs that are weak, moderate, or strong CYP1A2 inhibitors, increase the plasma concentration of VEOZAH.
|useInPregnancyFDA=no data on VEOZAH use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
|useInRenalImpair=VEOZAH is contraindicated in individuals with severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2) .

Dosage adjustment is not required for mild and moderate renal impairement.
|useInHepaticImpair=Child-Pugh Class A or B hepatic impairment increased the exposure of VEOZAH, however VEOZAH has not been studied in individuals with Child-Pugh Class C hepatic impairment.

VEOZAH is contraindicated in individuals with cirrhosis
|administration=VEOZAH (fezolinetant) is administered orally once daily as a single tablet of 45 mg with or without meal.

If a dose of VEOZAH is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose and return to the regular schedule the following day.
|monitoring=Serum AST, ALT and Bilirubin should be evaluated prior to initiating this medication to evaluate for hepatic injury/failure.

During the treatment phase using VEOZAH, follow-up bloodwork is performed at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms (such as nausea, vomiting, or yellowing of the skin or eyes) suggest liver injury.
|structure=The chemical name of fezolinetant is (4-Fluorophenyl)[(8R)-8-methyl-3-(3-methyl-1,2,4-thiadiazol-5-yl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]methanone having a molecular formula of C16H15FN6OS and a molecular weight of 358.39.
|brandNames=VEOZAH
}}

Fezolinetant

2024-05-15T03:44:55Z

Alen Antony:

Fezolinetant

2024-05-15T03:37:45Z

Alen Antony:

Fezolinetant

2024-05-15T02:46:26Z

Alen Antony:

Fezolinetant

2024-05-15T02:24:14Z

Alen Antony:

Fezolinetant

2024-05-15T01:32:59Z

Alen Antony:

Fezolinetant

2024-05-15T01:09:26Z

Alen Antony:

Fezolinetant

2024-05-14T21:44:26Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|OTC=Yes
|genericName=fezolinetant
|indicationType=treatment
|indication=moderate to severe vasomotor symptoms due to menopause.
|adverseReactions=abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.
|fdaLIADAdult=Fezolinetant is used to treat moderate and severe vasomotor symptoms due to menopause.

The recommended dosage is 45 mg administered orally as a tablet, once daily with or without meal. Always perform blood work to evaluate for hepatic impairment/failure prior to initiation of the treatment and follow up with blood workup every 3 months, 6 months and 9 months after initiating the therapy.
|contraindications=*Known history of cirrhosis

*Known history of Severe renal impairment or end-stage renal disease

*Concomitant use with CYP1A2 inhibitors
|warnings=Elevation of Hepatic transaminases
}}

Fezolinetant

2024-05-14T21:34:08Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|OTC=Yes
|genericName=fezolinetant
|indicationType=treatment
|indication=moderate to severe vasomotor symptoms due to menopause.
}}

Fezolinetant

2024-05-13T23:48:22Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |OTC=Yes |genericName=fezolinetant }}"

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|OTC=Yes
|genericName=fezolinetant
}}

Nirsevimab-alip

2024-05-13T23:46:19Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=Nirsevimab-alip
|aOrAn=a
|drugClass=human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody
|indicationType=prevention
|indication=Respiratory Syncytial Virus (RSV) lower respiratory tract disease for neonates and infants born during or entering their first RSV season and children up to 24 years of age who are vulnerable to severe RSV disease in their second RSV season.
|adverseReactions=rashes and injection site reactions.
|fdaLIADAdult=BEYFORTUS is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and children up to age 24 years during the RSV season.

The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season, which is given intramuscularly:
Less than 5 kg: 50 mg of IM injection
5 kg or greater: 100 mg of IM injection

The recommended dosage for children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season is 200 mg administered as two doses (100 mg each).
|contraindications=BEYFORTUS is contraindicated in children who have any history of hypersensitivity reaction to nirsevimab-alip or to any of the excipients.
|warnings=1. Hypersensitivity Reactions Including Anaphylaxis
some children may develop severe hypersensitivity reactions like urtricaria, dyspnea, cyanosis, or hypotonia following the administration. Since BEYFORTUS is a human immunoglobulin G1 (IgG1) monoclonal antibodies, it may even cause anaphylatic reaction. Appropriate treatment should be immediately given if the child develops any of the reaction.

2. Usage in children with bleeding and coagulation disorder.
Since BEYFORTUS is administered intramuscularly, it should given with caution in the children with thrombocytopenia and other bleeding disorder.
|clinicalTrials=The adverse effects reported from a clinical trial consisting of 3,224 pediatric subjects, in which 2,570 received BEYFORTUS and 0.9% experienced rashes and 0.3% experienced injection site reactions (pain, induration, edema, swelling) and 1,284 received Placebo had experienced 0.6% experienced rashes.
|useInPregnancyFDA=BEYFORTUS is not indicated for use in females of reproductive potential.
|useInLaborDelivery=BEYFORTUS is not indicated for use in females of reproductive potential.
|useInNursing=BEYFORTUS is not indicated for use in females of reproductive potential.
|useInReproPotential=BEYFORTUS is not indicated for use in females of reproductive potential.
|administration=BEYFORTUS is administered intramuscularly

The recommended dosage for neonates and infants born during or entering their first RSV season depends upon the body weight:
Less than 5 kg: 50 mg of IM injection
5 kg or greater: 100 mg of IM injection

The recommended dosage for children up to age of 24 months who remain at increased risk for severe RSV disease in their second RSV season, is a single 200 mg dose administered as two IM injections (2 x 100 mg).

Children Undergoing Cardiac Surgery with Cardiopulmonary Bypass:
For children undergoing cardiac bypass surgery, they may receive additional dosage of BEYFORTUS after the child is stable post-surgery.
For the first RSV season, if the surgery was in 90 days of receiving BEYFORTUS additional dose is given as per body weight and if after 90 days the additional dose is 50 mg regardless of body weight.
For the second RSV season, if surgery is within 90 days of receiving BEYFORTUS additional dose is 200mg and if after 90 days additional dose is 100mg.
|monitoring=BEYFORTUS can be given co-adminstered with other childhood vaccines, but should not be given with the same syringe or vial.

There is no information regarding co-administration of BEYFORTUS with other immunoglobulin products.
Palivizumab should not be administered to infants who have already received BEYFORTUS in the same season
|mechAction=BEYFORTUS is a monoclonal antibody with anti-RSV activity.
This provides passive immunity by targeting the prefusion conformation of the RSV F protein which then neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry.
|structure=Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa.
|PK=The estimated nirsevimab-alip absolute bioavailability is 84% and the median time to maximum concentration is 6 days.

The estimated nirsevimab-alip total volume of distribution is 477 mL, for an infant weighing 5 kg.

The nirsevimab-alip terminal half-life is approximately 71 days and the estimated clearance is 3.42 mL/day for an infant weighing 5 kg.

Nirsevimab-alip is degraded into small peptides by catabolic pathway.
|howSupplied=BEYFORTUS injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as,
*One 50 mg/0.5 mL single-dose pre-filled syringe in a carton
*Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton
*One 100 mg/mL single-dose pre-filled syringe in a carton
*Five 100 mg/mL single-dose pre-filled syringes in a carton
|storage=Store refrigerated between 36°F to 46°F (2°C to 8°C).
BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours.
After removal from the refrigerator, BEYFORTUS must be used within 8 hours or
discarded.
Store BEYFORTUS in original carton to protect from light until time of use.
Do not freeze. Do not shake. Do not expose to heat.
|brandNames=BEYFORTUS
}}

Nirsevimab-alip

2024-05-13T14:50:07Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=Nirsevimab-alip |aOrAn=a |drugClass=human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody |indicationType=prevention |indication=Respiratory Syncytial Virus (RSV) lower respiratory tract disease for neonates and infants born during or entering their first RSV season and children up to 24 years of age who are vulnerable to severe RSV disease in their second RSV season. |adverseReactions=rashes and injection..."

Sotagliflozin

2024-05-10T19:11:43Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=sotagliflozin
|aOrAn=a
|drugClass=sodium-glucose co-transporter 2 (SGLT2) inhibitor
|indicationType=prophylaxis
|indication=heart failure in patients with history of heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
|adverseReactions=urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
|fdaLIADAdult=Sotagliflozin is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure in patients with history of heart failure or with underlying comorbidities like diabetes mellitus, chronic kidney disease and other cardiovascular risk factors

The recommended starting dose is 200mg mg administered orally once daily not more than one hour before the meal. It can up titrated to 400mg once daily as tolerated only after 2 weeks.

Always assess the volume status and renal function prior to administering the drug. If the patient has decompensated heart failure, Sotagliflozin is administered as soon as the patient in hemodynamically stable.
|contraindications=Sotagliflozin is contraindicated in patients with hypersensitivity reaction to Sotagliflozin.
|warnings=1. Diabetic ketoacidosis

2. volume depleation'

3. Urosepsis

4. Hypoglycemia with concomitant usage of insulin and insulin secretagogues

5. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)

6. Genital Mycotic Infections

7. Avoid monitoring Glucose level through urine glucose test while on Sotagliflozin as SGLT2 inhibition leads to glucosuria casing Urine Glucose test to be positive.
|drugInteractions=1. Digoxin
there is increase in digoxin level when concomitantly administered with INPEFA.
Always monitor the blood digoxin level while INPEFA.

2. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer
INPEFA undergoes glucorindation by UGT forming 3-O-glucuronide, Therefore coadministration with a UGT inducer like Rifampin will lead to decreased exposure to sotagliflozin. Hence, decreased efficacy of Sotagliflozin.

3. Lithium
Co-administration of Lithium with a SGLT2 inhibitor like Sotagliglozin will lead to decreased exposure to Lithium, hence decreased efficacy of Lithium. Alway monitor the serum level of Lithium while on Sotagliflozin.
|FDAPregCat=X
|useInPregnancyFDA=Based on the animal study,INPEFA is best avoided in the 2nd and 3rd trimester as renal anomalies were observed in the second and third trimester.
In rats, the exposure approximately 5 times the clinical exposure at the maximum recommended human dose (MRHD) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible
|useInNursing=There has been no data regarding the presence of INPEFA in human milk, the effects on the breastfed infant, or the effects on milk production.

However, studies has shown presence of INPEFA in the rat milk indicating the human milk to most likely have the drug and thus best avoided during the breastfeeding period.
|useInRenalImpair=Patients with eGFR < 30 mL/min/1.73 m2 relative to the overall safety population had volume related adverse affects like hypotention, and dizziness
|useInHepaticImpair=INPEFA is not recommended in patients with moderate or severe hepatic impairment because there was 3-fold and 6-fold increase in blood INPEFA level in patients with moderate and severe hepatic failure respectively in comparison to normal hepatic functioning patient.

However, no dose adjustment of INPEFA was required for patients with mild hepatic failure.
|administration=INPEFA tablets contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor which is administered orally.

INPEFA tablets are available in 200mg and 400mg.
The patients are usually started at 200mg given not more than 1 hour before the first meal of the day. It can uptitarted to 400mg only after 2 weeks if the patients tolerate it well.
|monitoring=Always assess the volume status and correct the depletion if necessary prior to administering the INPEFA.

If the patients are hospitalized due to decompensated heart failure, INPEFA is administered as soon as the patient's vitals recovers to normal baseline.

If the patient is fasting due to surgery or any procedures, their INPEFA is kept on hold for atleast 3 days.
|mechAction=Sotagliflozin is an inhibitor of SGLT2 and SGLT1.
Inhibiting the Sodium-glucose cotransport inhibitor-2 decreases the reabsorption of sodium and glucose further lowering both pre-and afterload of the heart and downregulating sympathetic activity. However, the exact mechanism for sotagliflozin's cardiovascular benefits has not been established.

Inhibiting SGLT1 reduces the absorption of intestinal absorption of glucose further leading to diarrhea.
|structure=The molecular formula is C21H25ClO5S and the molecular weight is 424.94
|PD=Plasma Cmax and AUC of sotagliflozin increased in a dose-proportional manner in the therapeutic dose range of 200 mg to 400 mg once daily.
|howSupplied=INPEFA tablets are available in 200mg (blue color) and 400mg (yellow color) in a bottle of 30.
|storage=Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
|brandNames=INPEFA
}}

Sotagliflozin

2024-05-10T18:12:37Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=sotagliflozin
|aOrAn=a
|drugClass=sodium-glucose co-transporter 2 (SGLT2) inhibitor
|indicationType=prophylaxis
|indication=heart failure in patients with history of heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
|adverseReactions=urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
|fdaLIADAdult=Sotagliflozin is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure in patients with history of heart failure or with underlying comorbidities like diabetes mellitus, chronic kidney disease and other cardiovascular risk factors

The recommended starting dose is 200mg mg administered orally once daily not more than one hour before the meal. It can up titrated to 400mg once daily as tolerated only after 2 weeks.

Always assess the volume status and renal function prior to administering the drug. If the patient has decompensated heart failure, Sotagliflozin is administered as soon as the patient in hemodynamically stable.
|contraindications=Sotagliflozin is contraindicated in patients with hypersensitivity reaction to Sotagliflozin.
|warnings=1. Diabetic ketoacidosis

2. volume depleation'

3. Urosepsis

4. Hypoglycemia with concomitant usage of insulin and insulin secretagogues

5. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)

6. Genital Mycotic Infections

7. Avoid monitoring Glucose level through urine glucose test while on Sotagliflozin as SGLT2 inhibition leads to glucosuria casing Urine Glucose test to be positive.
|drugInteractions=1. Digoxin
there is increase in digoxin level when concomitantly administered with INPEFA.
Always monitor the blood digoxin level while INPEFA.

2. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer
INPEFA undergoes glucorindation by UGT forming 3-O-glucuronide, Therefore coadministration with a UGT inducer like Rifampin will lead to decreased exposure to sotagliflozin. Hence, decreased efficacy of Sotagliflozin.

3. Lithium
Co-administration of Lithium with a SGLT2 inhibitor like Sotagliglozin will lead to decreased exposure to Lithium, hence decreased efficacy of Lithium. Alway monitor the serum level of Lithium while on Sotagliflozin.
|FDAPregCat=X
|useInPregnancyFDA=Based on the animal study,INPEFA is best avoided in the 2nd and 3rd trimester as renal anomalies were observed in the second and third trimester.
In rats, the exposure approximately 5 times the clinical exposure at the maximum recommended human dose (MRHD) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible
|useInNursing=There has been no data regarding the presence of INPEFA in human milk, the effects on the breastfed infant, or the effects on milk production.

However, studies has shown presence of INPEFA in the rat milk indicating the human milk to most likely have the drug and thus best avoided during the breastfeeding period.
|useInRenalImpair=Patients with eGFR < 30 mL/min/1.73 m2 relative to the overall safety population had volume related adverse affects like hypotention, and dizziness
|useInHepaticImpair=INPEFA is not recommended in patients with moderate or severe hepatic impairment because there was 3-fold and 6-fold increase in blood INPEFA level in patients with moderate and severe hepatic failure respectively in comparison to normal hepatic functioning patient.

However, no dose adjustment of INPEFA was required for patients with mild hepatic failure.
|administration=INPEFA tablets contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor which is administered orally.

INPEFA tablets are available in 200mg and 400mg.
The patients are usually started at 200mg given not more than 1 hour before the first meal of the day. It can uptitarted to 400mg only after 2 weeks if the patients tolerate it well.
|monitoring=Always assess the volume status and correct the depletion if necessary prior to administering the INPEFA.

If the patients are hospitalized due to decompensated heart failure, INPEFA is administered as soon as the patient's vitals recovers to normal baseline.

If the patient is fasting due to surgery or any procedures, their INPEFA is kept on hold for atleast 3 days.
|structure=The molecular formula is C21H25ClO5S and the molecular weight is 424.94
|brandNames=INPEFA
}}

Sotagliflozin

2024-05-10T17:54:10Z

Alen Antony:

Sotagliflozin

2024-05-10T17:46:29Z

Alen Antony:

Sotagliflozin

2024-05-10T17:12:00Z

Alen Antony:

Sotagliflozin

2024-05-09T23:59:56Z

Alen Antony:

Sotagliflozin

2024-05-09T15:17:56Z

Alen Antony:

Sotagliflozin

2024-05-09T04:57:37Z

Alen Antony: Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=sotagliflozin |aOrAn=a |drugClass=sodium-glucose co-transporter 2 (SGLT2) inhibitor |indicationType=prophylaxis |indication=heart failure in patients with risk of heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. |adverseReactions=urinary tract infection, volume depletion, diarrhea, and hypoglycemia. }}"

Zuranolone

2024-05-08T04:13:42Z

Alen Antony:

{{DrugProjectFormSinglePage
|authorTag={{AAP}}
|genericName=zuranolone
|aOrAn=a
|drugClass=gamma-aminobutyric acid (GABA) A receptor positive modulator
|indicationType=treatment
|indication=postpartum depression (PPD) in adults
|hasBlackBoxWarning=Yes
|adverseReactions=somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
|blackBoxWarningTitle=Impaired ability to engage in potential hazardous activity
|blackBoxWarningBody=Patients are advised to avoid potential hazardous activity like driving for 12 hours after taking zuranolone during the 14 day treatment regimen.
Zuranolone causes driving impairment as it results in CNS depressing effects.

Patients are also advised that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE.
|fdaLIADAdult=ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.

The recommended dose of Zurzuvae is 50mg taken orally once daily for 14 days. It is ideally advised to be taken with fat containing food (e.g., 400 to 1,000 calories, 25% to 50% fat).

Zurzuvae is taken alone or as an adjunct to other antidepressant.
The effectiveness and safety of this drug has not been studied beyond 14 days.
|contraindications=none
|warnings=1. Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities
Due to the central nervous system depressing effects, ZURZUVAE may impair the ability to drive or perform potentially hazardous activity. Thus, patients are who on ZUZUVAE are advised to refrain from driving for 12hrs after administering the drug during 14 day treatment course. They are also informed that they are not capable to assess their own ability to drive.

2. Central Nervous System Depressant Effects
the effects are somnolence and confusion, thus putting the patients at a higher risk of fall.
Other CNS depressants such as alcohol, benzodiazepines, opioids, tricyclic antidepressants, or drugs that increase zuranolone concentration, may increase impairment of psychomotor performance or CNS depressant effects such as somnolence, cognitive impairment, and the risk of respiratory depression in ZURZUVAE-treated patients.
Therefore patients are advised to reduce the dosage of ZURZUVAE if they experience somnolence or confusion, or if they are taking it along other unavoidable CNS depressant drugs.

3. Suicidal Thoughts and Behavior
consider discontinuing the drug if the patients experiences worsening of the depression or develops suicidal thoughts or behavior.

4. Embryo-fetal Toxicity
as animal studies indicated that ZURZUVAE causes fetal harm like fetal malformations, embryofetal and offspring mortality, growth deficits, it is best avoided during pregnancy. Studies also showed that it caused neuronal death when rats were exposed to zuranolone during a period of brain development. Women are advised to be on contraceptives during the treatment course and also for 1 week following the last dose of ZURZUVAE.
|clinicalTrials=In the placebo-controlled clinical studies in 347 women with PPD treated with 50 mg of ZURZUVAE (Study 1) once daily for 14 days, showed the most common adverse effects to be : somnolence (36%), dizziness(16%), diarrhea (6%), fatigue(5%), UTI(5%) and others being memory impairment, tremors, hypoesthesia, muscle twitching, myalgia, anxiety and rash.

While in another placebo-controlled clinical studies in 347 women with PPD treated with another zuranolone capsule formulation approximately equivalent to 40 mg of ZURZUVAE (Study 2) once daily for 14 days showed common adverse effects of : somnolence (19%), nasopharyngitis (9%), dizziness(8%) while other less common being fatigue , diarrhea, dry mouth, sinus congestion and tooth ache.
|drugInteractions=1. CNS depressant drug and alcohol.
Concomitant administration of the above mentioned drugs with ZURZUVAE may increase impairment of psychomotor performance or CNS depressant effects.
If the CNS depressant drug is unavoidable, suggest dosage reduction of ZURZUVAE.

2.Strong CYP3A4 Inhibitors
Concomitant usage of ZURZUVAE with a strong CYP3A4 Inhibitors may result in prolonged exposure of ZURZUVAE increasing the risk of the adverse effects.

3.CYP3A4 Inducers
concomitant usage of ZURZUVAE can cause decreased efficacy of ZURZUVAE.
|FDAPregCat=X
|useInPregnancyFDA=oral administration of zuranolone to pregnant rats during organogenesis resulted in developmental toxicity, including embryofetal death and fetal malformations, with a no adverse effect level (NOAEL) associated with maternal plasma exposures 7 times greater than in humans at the maximum recommended human dose (MRHD) of 50 mg.
Neuronal death was observed in rats exposed to zuranolone during a period of brain development that begins during the third trimester of pregnancy in humans and continues up to a few years after birth.
|useInRenalImpair=The exposure to zuranolone was increased in patients with moderate (eGFR 30 to 59 mL/min/1.73 m2) and severe (eGFR 15 to 29 mL/min/1.73 m2) renal impairment .
Therefore the dose of zuranolone is reduced in patients with moderate or severe renal impairment.
|useInHepaticImpair=Exposure to zuranolone was increased in patients with severe hepatic impairment (Child-Pugh C). The recommended ZURZUVAE dosage in patients with severe hepatic impairment is therefore reduced.

However, no change in dosage is required for mild or moderate hepatic impairment.
|administration=The recommended dosage is 50 mg, administered orally once daily for 14 days.
If a dose is missed, the missed dose is taken on the next day as the regular schedule, never double the dosage.

If the patient experiences CNS depressing effects like somnolence or confusion, reduce the dosage to 40mg.
If the patient has severe hepatic impairment(child-Pugh C), the recommended dosage is 30 mg orally once daily in the evening for 14 days.
If the patient has moderate or Severe Renal Impairment, the recommended dosage is 30 mg orally once daily in the evening for 14 days.
|overdose=Overdosage with ZURZUVAE may result in excessive CNS depressant effects such as somnolence and disturbance in consciousness.
There is no specific antidote for ZURZUVAE overdosage.
|mechAction=The mechanism of action of zuranolone in the treatment of PPD is not fully understood, but is to be related to its positive allosteric modulation of GABAA receptors.
|PK=Zuranolone attains peak concentrations at 5 to 6 hours (Tmax) following oral administration.

The volume of distribution of zuranolone following oral administration is greater than 500 L with a plasma protein binding greater than 99.5%.

The terminal half-life of zuranolone is approximately 19.7 to 24.6 hours in an adult population with the mean apparent clearance (CL/F) of zuranolone is 33 L/h.

Zuranolone undergoes extensive metabolism, with CYP3A4 identified as a primary enzyme involved.

45% of the dose was excreted in urine as metabolites with negligible unchanged zuranolone and 41% in feces as metabolites with less than 2% as unchanged zuranolone.
|howSupplied=ZURZUVAE (zuranolone) is supplied as 20 mg, 25 mg, and 30 mg capsules.

20mg capsule- light-orange cap, ivory to light-yellow body - available in a bottle on 14 capsules

25mg capsule- light-orange cap, light-orange body - available in a bottle on 14 capsules or blister pack of 28

30mg capsule- orange cap, light-orange body- available in a bottle on 14 capsules
|storage=Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
|brandNames=ZURZUVAE
}}

Zuranolone

2024-05-08T03:48:09Z

Alen Antony:

Zuranolone

2024-05-07T20:18:58Z

Alen Antony: