wikidoc - User contributions [en]

FUTIBATINIB

2024-05-22T04:02:57Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER, MD
|OTC=Yes
|genericName=FUTIBATINIB
|aOrAn=a
|drugClass=Kinase Inhibitor
|indicationType=treatment
|indication=of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
|adverseReactions=Nail Toxicity, stomatitis, dry skin, dry eye, alopecia, Musculoskeletal pain, arthralgia, Palmar-plantar eryhtrodysesthesia syndrome, Constipation, diarrhea, fatigue, abdominal pain, nausea, vomiting, decreased appetite, urinary tract infection and lab findings include increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.
|fdaLIADAdult=The recommended dosage of futibatinib is 20 mg (five 4 mg tablets) taken orally once daily until disease progression or unacceptable toxicity occurs. If the patient misses a dose of futibatinib for more than 12 hours or if vomiting occurs, resume dosing with the next scheduled dose.
|fdaLIADPed=The safety and effectiveness of futibatinib have not been established in pediatric patients.
|contraindications=There is no specific contraindication related to futibatinib.
|warnings===OCULAR TOXICITY==
===RETINAL PIGMENT EPITHELIAL DETACHMENT(RPED)===
Futibatinib can cause RPED, which may cause symptoms such as blurred vision. Perform a comprehensive ophthalmological examination, including optical coherence tomography(OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of futibatinib.
===DRY EYES/CORNEAL KERATITIS===
Treat patients of dry eyes/keratitis with ocular demulcents as needed.
==HYPERPHOSPHATEMIA AND SOFT TISSUE MINERALIZATION==
Futibatinib can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Monitor for hyperphosphatemia throughout treatment. Initiate a low phosphate diet and phosphate lowering therapy when serum phosphate level is ≥5.5 mg/dl. For serum phosphate levels >7 mg/dl, initiate or intensify phosphate lowering therapy and dose reduce, withhold, or permanently discontinue futibatinib based on duration and severity of hyperphosphatemia.
==EMBRYO-FETAL TOXICITY==
Advise pregnant women of the potential risk to the fetus including fetal malformations, fetal growth retardation, and embryo-fetal death . Advise female patients of reproductive potential to use effective contraception during treatment with futibatinib and for 1 week after the last dose of futibatinib. Advise males with female partners of reproductive potential to use effective contraception during treatment with futibatinib and for 1 week after the last dose.
|clinicalTrials=*GASTROINTESTINAL:
constipation, diarrhea, dry mouth, stomatitis, abdominal pain, nausea and vomiting.
*SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
nail toxicity, alopecia, dry skin, palmar-plantar erythrodysesthesia syndrome.
* METABOLISM AND NUTRITION DISORDERS:
Decreased appetite.
*MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS:
Musculoskeletal pain and arthralgia
*EYE DISORDERS:
Dry eyes and retinal pigment epithelial detachment.
*NERVOUS SYSTEM DISORDER:
Dysgeusia
*INFECTION:
Urinary tract infection.
*GENERAL DISORDERS:
fatigue, decreased weight.
*HEMATOLOGY:
decreased hemoglobin, decreased lymphocytes, decreased platelets, decreased leukocytes and decreased neutrophils.
*CHEMISTRY:
Increased phosphate, increased creatinine, increased calcium, increased glucose, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphate, increased aspartate aminotransferase, decreased albumin, increased creatine kinase, increased bilirubin, decreased glucose, decreased potassium and increased potassium.
|drugInteractions=*Futibatinib is a substrate of CYP3A and P-gp.
**Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors with futiatinib. Concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors with futibatinib may increase futibatinib exposure.
** Avoid concomitant use of dual P-gp and strong CYP3A inducers with futibatinib.
Concomitant use of drugs that are dual P-gp and strong CYP3A inducers may decrease futibatinib exposure
}}

FUTIBATINIB

2024-05-09T10:45:33Z

Hafiza Amna Qadeer:

FUTIBATINIB

2024-05-09T10:37:22Z

Hafiza Amna Qadeer: Created page with "{{DrugProjectFormSinglePage |authorTag=HAFIZA AMNA QADEER, MD |OTC=Yes |genericName=FUTIBATINIB |aOrAn=a |drugClass=Kinase Inhibitor |indicationType=treatment |indication=* of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. |adverseReactions=1* Nail Toxicity, stomatitis, dry skin, dry eye, alopecia 2* Musculos..."

SCAPULOPERONEAL SPINAL MUSCULAR ATROPHY

2024-04-24T07:55:10Z

Hafiza Amna Qadeer:

'''OVERVIEW'''

A [[scapuloperoneal spinal muscular atrophy]](SPSMA) is a rare [[autosomal dominant]] genetic motor neuron disease characterized by predominantly motor axonal peripheral neuropathy manifesting with progressive scapuloperoneal spinal muscular atrophy and weakness, laryngeal palsy, congenital absence of muscles, and, in some, skeletal abnormalities. The scapuloperoneal spinal muscular atrophy is caused by heterozygous mutation in the [[TRPV4]] [[gene]] on chromosome 12q24.<ref name="pmid20037587">{{cite journal| author=Deng HX, Klein CJ, Yan J, Shi Y, Wu Y, Fecto F | display-authors=etal| title=Scapuloperoneal spinal muscular atrophy and CMT2C are allelic disorders caused by alterations in TRPV4. | journal=Nat Genet | year= 2010 | volume= 42 | issue= 2 | pages= 165-9 | pmid=20037587 | doi=10.1038/ng.509 | pmc=3786192 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20037587 }} </ref> Congenital distal spinal muscular atrophy and hereditary sensory and motor neuropathy are allelic disorders with overlapping features.
----'''INHERITANCE'''

The transmission pattern of scapuloperoneal spinal muscular atrophy(SPSMA) is consistent with autosomal dominant inheritance.<ref name="pmid1520078">{{cite journal| author=DeLong R, Siddique T| title=A large New England kindred with autosomal dominant neurogenic scapuloperoneal amyotrophy with unique features. | journal=Arch Neurol | year= 1992 | volume= 49 | issue= 9 | pages= 905-8 | pmid=1520078 | doi=10.1001/archneur.1992.00530330027010 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=1520078 }} </ref>
----'''PREVALENCE'''

The prevalence of scapuloperoneal spinal muscular arophy(SPSMA) is < 1/1000000.
----'''AGE OF ONSET'''

Childhood, Infancy, Neonatal.
----'''CLINICAL FEATURES'''

* Congenital Absence of muscles, weakness and atrophy of the proximal upper and lower muscles
* Progressive scapuloperoneal atrophy
* Laryngeal Palsy resulting in hoarse voice and respiratory stridor
* Progressive distal weakness and amyotrophy
* Torticollis
* Congenital Hip Dysplasia
* Fascial Muscle Paresis, Neck Flexor weakness
* Abducens weakness
* Wide based gait, hyper-lordosis and Gowers sign
* Small hands and one arm or leg shorter than other

----

SCAPULOPERONEAL SPINAL MUSCULAR ATROPHY

2024-04-24T07:52:15Z

Hafiza Amna Qadeer: added clinical features

SCAPULOPERONEAL SPINAL MUSCULAR ATROPHY

2024-04-17T20:47:20Z

Hafiza Amna Qadeer: minor edit

'''OVERVIEW'''

A [[scapuloperoneal spinal muscular atrophy]] is a rare [[autosomal dominant]] genetic motor neuron disease characterized by predominantly motor axonal peripheral neuropathy manifesting with progressive scapuloperoneal spinal muscular atrophy and weakness, laryngeal palsy, congenital absence of muscles, and, in some, skeletal abnormalities.
----

SCAPULOPERONEAL SPINAL MUSCULAR ATROPHY

2024-04-17T20:46:33Z

Hafiza Amna Qadeer: new page minor edit

<nowiki>=OVERVIEW=</nowiki>

A [[scapuloperoneal spinal muscular atrophy]] is a rare [[autosomal dominant]] genetic motor neuron disease characterized by predominantly motor axonal peripheral neuropathy manifesting with progressive scapuloperoneal spinal muscular atrophy and weakness, laryngeal palsy, congenital absence of muscles, and, in some, skeletal abnormalities.
----

SCAPULOPERONEAL SPINAL MUSCULAR ATROPHY

2024-04-17T19:33:06Z

Hafiza Amna Qadeer: Created blank page

Rezafungin

2024-03-24T20:04:34Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=echinocandin antifungal
|indicationType=treatment
|indication=of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
|adverseReactions=diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=Rezafungin is indicated for the treatment of candidemia and invasive candidiasis. Administer the recommended dosage of Rezafungin once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of Rezafungin has not been established beyond 4 weekly doses. Rezafungin is administered by intravenous infusion over approximately one hour(~250ml/h).
|fdaLIADPed=The safety and effectiveness of Rezfungin have not been established in pediatric patients.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion Related Reactions
Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with REZZAYO. If these reactions occur, slow or pause the infusion and restart at a lower rate.
* Photosensitivity
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
* Hepatic Adverse Reactions
In some patients with serious underlying medical conditions who were receiving multiple other medications along with Rezafungin, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezafungin therapy and evaluate patients for their risk/benefit of continuing Rezafungin therapy.
|postmarketing=* GASTROINTESTINAL DISORDERS
Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), Diarrhea, Nausea, Vomiting, Abdominal pain and constipation
* METABOLISM AND NUTRITION DISORDERS
Hypokalemia, Hypomagnesemia and hypophosphatemia
* BLOOD AND LYMPHATIC SYSTEM DISORDER
Anemia, Disseminated Intravascular Coagulation
* NERVOUS SYSTEM
Tremor, headache, Insomnia, Dizziness and peripheral neuropathy (includes neuropathy peripheral, polyneuropathy and peroneal nerve palsy).
* CARDIOVASCULAR SYSTEM
Fluid Overload
* INTEGUMENTARY SYSTEM
Flushing, Erythema, photosensitivity, Sensation of warmth and Urticaria
* GENITOURINARY SYSTEM
Abnormal renal functions(Acute Kidney Injury)
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=No sufficient clinical data available.
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|overdose=Rezafungin is highly protein bound and not anticipated to be dialyzable and no case reported during clinical trials.
|howSupplied=* REZZAYO (rezafungin for injection) is supplied as sterile white to pale yellow solid (cake or powder) in a single-dose 20 mL Type I glass vial with a stopper, an aluminum seal, and blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex.

* REZZAYO is available in the following packaging configuration:

One single-dose vial of REZZAYO 200 mg (NDC 70842-240-01)
|storage=* REZZAYO VIALS
Rezafungin vials should be stored at 20°C to 25°C (68°F to 77°F). Short exposure to 15°C to 30°C (59°F to 86°F) permitted.
* RECONSTITUTED SOLUTION
REZZAYO reconstituted solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 24 hours.
* IV INFUSION SOLUTION
REZZAYO infusion solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 48 hours. Do not freeze the solution.
|packLabel=Carton Label - One 200 mg Sterile Single-dose Vial - REZZAYO

PRINCIPAL DISPLAY PANEL
NDC 70842-240-01

Rx only

REZZAYO™
(rezafungin for injection)
200 mg per vial

Vial contains rezafungin:

200 mg (equivalent to 210 mg of rezafungin acetate).
For intravenous Infusion Only
Must be reconstituted and further diluted.
|fdaPatientInfo=Patient should be counselled about photosensitivity related to rezafungin and advised to use protection against sun exposure and other sources of UV radiation during treatment.
|brandNames=REZZAYO
}}

Rezafungin

2024-03-24T02:52:56Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=echinocandin antifungal
|indicationType=treatment
|indication=of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
|adverseReactions=diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=Rezafungin is indicated for the treatment of candidemia and invasive candidiasis. Administer the recommended dosage of Rezafungin once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of Rezafungin has not been established beyond 4 weekly doses. Rezafungin is administered by intravenous infusion over approximately one hour(~250ml/h).
|fdaLIADPed=The safety and effectiveness of Rezfungin have not been established in pediatric patients.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion Related Reactions
Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with REZZAYO. If these reactions occur, slow or pause the infusion and restart at a lower rate.
* Photosensitivity
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
* Hepatic Adverse Reactions
In some patients with serious underlying medical conditions who were receiving multiple other medications along with Rezafungin, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezafungin therapy and evaluate patients for their risk/benefit of continuing Rezafungin therapy.
|postmarketing=* GASTROINTESTINAL DISORDERS
Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), Diarrhea, Nausea, Vomiting, Abdominal pain and constipation
* METABOLISM AND NUTRITION DISORDERS
Hypokalemia, Hypomagnesemia and hypophosphatemia
* BLOOD AND LYMPHATIC SYSTEM DISORDER
Anemia, Disseminated Intravascular Coagulation
* NERVOUS SYSTEM
Tremor, headache, Insomnia, Dizziness and peripheral neuropathy (includes neuropathy peripheral, polyneuropathy and peroneal nerve palsy).
* CARDIOVASCULAR SYSTEM
Fluid Overload
* INTEGUMENTARY SYSTEM
Flushing, Erythema, photosensitivity, Sensation of warmth and Urticaria
* GENITOURINARY SYSTEM
Abnormal renal functions(Acute Kidney Injury)
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=No sufficient clinical data available.
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|overdose=Rezafungin is highly protein bound and not anticipated to be dialyzable and no case reported during clinical trials.
|howSupplied=1* REZZAYO (rezafungin for injection) is supplied as sterile white to pale yellow solid (cake or powder) in a single-dose 20 mL Type I glass vial with a stopper, an aluminum seal, and blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex.

2* REZZAYO is available in the following packaging configuration:

One single-dose vial of REZZAYO 200 mg (NDC 70842-240-01)
|storage=* REZZAYO VIALS
Rezafungin vials should be stored at 20°C to 25°C (68°F to 77°F). Short exposure to 15°C to 30°C (59°F to 86°F) permitted.
* RECONSTITUTED SOLUTION
REZZAYO reconstituted solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 24 hours.
* IV INFUSION SOLUTION
REZZAYO infusion solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 48 hours. Do not freeze the solution.
|packLabel=Carton Label - One 200 mg Sterile Single-dose Vial - REZZAYO

PRINCIPAL DISPLAY PANEL
NDC 70842-240-01

Rx only

REZZAYO™
(rezafungin for injection)
200 mg per vial

* Vial contains rezafungin

200 mg (equivalent to 210 mg of rezafungin acetate).
For intravenous Infusion Only
Must be reconstituted and further diluted.
|fdaPatientInfo=Patient should be counselled about photosensitivity related to rezafungin and advised to use protection against sun exposure and other sources of UV radiation during treatment.
|brandNames=REZZAYO
}}

Rezafungin

2024-03-24T02:46:45Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=echinocandin antifungal
|indicationType=treatment
|indication=of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
|adverseReactions=diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=Rezafungin is indicated for the treatment of candidemia and invasive candidiasis. Administer the recommended dosage of Rezafungin once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of Rezafungin has not been established beyond 4 weekly doses. Rezafungin is administered by intravenous infusion over approximately one hour(~250ml/h).
|fdaLIADPed=The safety and effectiveness of Rezfungin have not been established in pediatric patients.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion Related Reactions
Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with rezafungin. If these reactions occur, slow or pause the infusion and restart at a lower rate.
* Photosensitivity
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
* Hepatic Adverse Reactions
In some patients with serious underlying medical conditions who were receiving multiple other medications along with Rezafungin, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezafungin therapy and evaluate patients for their risk/benefit of continuing Rezafungin therapy.
|postmarketing=* GASTROINTESTINAL DISORDERS
Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), Diarrhea, Nausea, Vomiting, Abdominal pain and constipation
* METABOLISM AND NUTRITION DISORDERS
Hypokalemia, Hypomagnesemia and hypophosphatemia
* BLOOD AND LYMPHATIC SYSTEM DISORDER
Anemia, Disseminated Intravascular Coagulation
* NERVOUS SYSTEM
Tremor, headache, Insomnia, Dizziness and peripheral neuropathy (includes neuropathy peripheral, polyneuropathy and peroneal nerve palsy).
* CARDIOVASCULAR SYSTEM
Fluid Overload
* INTEGUMENTARY SYSTEM
Flushing, Erythema, photosensitivity, Sensation of warmth, Urticaria
* GENITOURINARY SYSTEM
Abnormal renal functions(Acute Kidney Injury)
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=No sufficient clinical data available.
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|overdose=Rezafungin is highly protein bound and not anticipated to be dialyzable and no case reported during clinical trials.
|howSupplied=1* REZZAYO (rezafungin for injection) is supplied as sterile white to pale yellow solid (cake or powder) in a single-dose 20 mL Type I glass vial with a stopper, an aluminum seal, and blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex.
2* REZZAYO is available in the following packaging configuration:
One single-dose vial of REZZAYO 200 mg (NDC 70842-240-01)
|storage=* REZZAYO VIALS
Rezafungin vials should be stored at 20°C to 25°C (68°F to 77°F). Short exposure to 15°C to 30°C (59°F to 86°F) permitted.
* RECONSTITUTED SOLUTION
REZZAYO reconstituted solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 24 hours.
* IV INFUSION SOLUTION
REZZAYO infusion solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 48 hours. Do not freeze the solution.
|packLabel=Carton Label - One 200 mg Sterile Single-dose Vial - REZZAYO
PRINCIPAL DISPLAY PANEL
NDC 70842-240-01
Rx only
REZZAYO™
(rezafungin for injection)
200 mg per vial
* Vial contains rezafungin
200 mg (equivalent to 210 mg of rezafungin acetate).
For intravenous Infusion Only
Must be reconstituted and further diluted.
|fdaPatientInfo=Patient should be counselled about photosensitivity related to rezafungin and advised to use protection against sun exposure and other sources of UV radiation during treatment.
|brandNames=REZZAYO
}}

Rezafungin

2024-03-23T17:36:59Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-23T16:53:26Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-23T16:26:57Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=ANTIFUNGAL ECHINOCANDIN
|indicationType=treatment
|indication=Rezafungin is indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
|adverseReactions=diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
}}

Rezafungin

2024-03-23T04:40:38Z

Hafiza Amna Qadeer: Blanked the page

Rezafungin

2024-03-23T04:37:19Z

Hafiza Amna Qadeer: Undo revision 1737210 by Hafiza Amna Qadeer (talk)

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER, MD
|OTC=Yes
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=ANTIFUNGAL ECHINOCANDIN
|indicationType=treatment
|indication=Patients with invasive candidiasis and candidemia who are at least 18 years old and have few or no other options for treatment.
|adverseReactions=Diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=The recommended dosage of rezafungin is once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of rezafungin has not been established beyond 4 weekly doses. Rezafungin is used for intravenous infusion only. Administer rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion related reactions.
* Photosensitivity.
* Hepatic Adverse Reactions.
|clinicalTrials=The following adverse reaction can occur after administration of rezafungin:
=GASTROINTESTINAL=
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
=METABOLISM AND NUTRITION DISORDER=
Anemia, Disseminated Intravascular Coagulation.
=NERVOUS SYSTEM=
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|postmarketing=The following adverse reaction can occur after administration of rezafungin:
=GASTROINTESTINAL=
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
=METABOLISM AND NUTRITION DISORDER=
Anemia, Disseminated Intravascular Coagulation.
=NERVOUS SYSTEM=
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|drugInteractions=Rezafungin is not a substrate of CYP enzymes or drug transporter systems. Rezafungin is not an inhibitor or inducer of common drug metabolizing CYP enzymes or transporter systems.
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=Clinical studies of Rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInGender=Clinical studies of rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInRenalImpair=No clinically relevant effect on the pharmacokinetics of rezafungin were observed based on renal impairment (creatinine clearance: 9.3 mL/min to above 120 mL/min) and no effect is expected in patients undergoing hemodialysis.
|useInHepaticImpair=No clinically relevant effects on the pharmacokinetics of rezafungin were observed with hepatic impairment (Child Pugh Class B or C).
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|administration=Administer Rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|overdose=No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
|mechAction=Rezafungin is a semi-synthetic echinocandin. Rezafungin inhibits the 1,3-β-D-glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall of many fungi, including Candida species (spp.). Inhibition of 1,3-β-D-glucan synthesis results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown.
|structure=REZZAYO (rezafungin for injection), for intravenous use is a sterile solid (cake or powder) that contains rezafungin acetate. Rezafungin acetate is a semisynthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. REZZAYO is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. REZZAYO contains 210 mg of rezafungin acetate, equivalent to 200 mg of rezafungin. REZZAYO also contains 47 mg histidine, 500 mg mannitol, 450 mg polysorbate 80, and hydrochloric acid and/or sodium hydroxide for pH adjustment. Rezafungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water, soluble in methanol, and sparingly soluble in ethanol. Rezafungin acetate is chemically designated as Echinocandin B, 1-[(4R,5R)-4-hydroxy-N2-[[4"- (pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4S)-4- hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]-, acetate (1:1). The empirical formula of Rezafungin acetate is C63H85N8O17 • C2H3O2, and the formula weight is 1285.46 g/mol.
|PD=Rezafungin exposures achieved with the recommended dosage regimen appear to be on the plateau of the observed flat exposure-efficacy response curve in clinical studies. Rezafungin does not prolong the QTc interval to any clinically relevant extent at a dose 3.5 times the maximum approved recommended loading dose.
|PK=Following single and multiple dosing, the Cmax and AUC of rezafungin increase in a dose-proportional manner over a dose range of 50 mg (0.125 times the approved maximum recommended loading dose) to 400 mg.
|nonClinToxic==CARCINOGENESIS=
Carcinogenicity studies with rezafungin have not been conducted.
=MUTAGENESIS=
Rezafungin was negative in a standard battery of assays, including an in vitro bacterial reverse mutation assay, an in vitro mammalian clastogenicity assay, and an in vivo rat bone marrow micronucleus assay.
=IMPAIRMENT OF FERTILITY=
Rezafungin did not affect mating or fertility in male and female rats following IV administration once every 3 days at doses up to 45 mg/kg (6 times the clinical exposure, based on AUC determined in a separate rat study). Decreased sperm motility was noted at ≥30 mg/kg and most males at 45 mg/kg showed mild/moderate hypospermia and had no detectable motile sperm. At rezafungin doses ≥30 mg/kg there was an increased incidence of sperm with abnormal morphology as well as mild to moderate degeneration of the seminiferous tubules. In a 3-month study of every 3 day IV rezafungin in rats, males dosed at 45 mg/kg showed minimal tubular degeneration/atrophy in the testes and cellular debris in the epididymides at the end of 3 months. The incidence of this finding reduced by the end of a 4-week reversibility period. In contrast, sperm concentration, production rate, morphology and motility were unaffected in adult monkeys dosed weekly with rezafungin, up to 30 mg/kg (about 6 times the clinical dose based on AUC comparisons) for 11 or 22 weeks or after a 52-week recovery period.
|clinicalStudies=The safety and efficacy of REZZAYO in the treatment of patients with candidemia and/or invasive candidiasis (IC) were evaluated in a multicenter, randomized, double-blind study (Trial 1; NCT03667690). Patients were randomized in a 1:1 ratio to receive REZZAYO or caspofungin. Randomization was stratified based on diagnosis (candidemia only; IC) and by Acute Physiology and Chronic Health Evaluation II score (APACHE II)/absolute neutrophil count (ANC) at screening. Patients with septic arthritis in a prosthetic joint, osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection, chronic disseminated candidiasis, or urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract were excluded.

Patients in the REZZAYO arm were to receive a single 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of two to four doses. Patients in the caspofungin arm were to receive a single 70 mg IV loading dose, followed by caspofungin 50 mg IV once daily treatment for a total of 2 to 4 weeks. After ≥3 days of IV therapy, patients in the caspofungin group could be switched to oral step-down therapy (fluconazole), if the patient met the criteria for cure and was preparing to be discharged.

One hundred and ninety-nine patients in the intent-to-treat (ITT) population were randomized. The age range was 19-91 years, the gender distribution was 62% male and 38% female, and the race distribution was 61% White, 5% Black, 29% Asian, and 5% other races or not reported. The median duration of therapy was 14 days in the two treatment arms.

The modified ITT (mITT) population included 187 patients with a culture positive for Candida species within 4 days before randomization and who received at least one dose of study drug. The most frequent species isolated at baseline was C. albicans (42%), followed by C. glabrata (26%), C. tropicalis (20%), and C. parapsilosis (13%). The majority (70%) of patients had a diagnosis of candidemia only. The majority (93%) of patients were not neutropenic (ANC ≥500) and 84% had APACHE II scores less than 20. Risk factors for candidemia were: receipt of broad-spectrum antibacterial drugs (71%), presence of a central venous catheter (60%), major surgery (35%), diabetes mellitus (29%), active malignancy (25%), and total parenteral nutrition (20%). Mechanically ventilated patients were 24% (17% and 30% in the REZZAYO and caspofungin group, respectively).

Efficacy was assessed by all-cause mortality at Day 30. The number and percentage of patients in each treatment group who were alive and deceased/unknown survival status at Day 30 was determined in the mITT population. Additional efficacy outcomes were global cure (mycological eradication/presumed eradication, clinical cure, and radiological cure [for patients with documented IC by radiologic or other imaging findings at baseline]), mycological eradication/presumed eradication, and investigator’s assessment of clinical cure.
|howSupplied=Rezafungin is supplied as a single-dose vial containing 200 mg of Rezafungin. For the 400 mg dose, aseptically reconstitute two vials each with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL in each vial. For the 200 mg dose, aseptically reconstitute one vial with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL
|storage=Store Rezafungin infusion solution between 5°C to 25°C (41°F to 77°F). Stability of the infusion solution has been demonstrated for 48 hours at 5°C to 25°C (41°F to 77°F).
|brandNames=REZZAYO
}}

Rezafungin

2024-03-23T04:26:06Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER, MD
|OTC=Yes
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=ANTIFUNGAL ECHINOCANDIN
|indicationType=treatment
|indication=patients with invasive candidiasis and candidemia who are at least 18 years old and have few or no other options for treatment.
|adverseReactions=Diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=The recommended dosage of rezafungin is once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of rezafungin has not been established beyond 4 weekly doses. Rezafungin is used for intravenous infusion only. Administer rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion related reactions.
* Photosensitivity.
* Hepatic Adverse Reactions.
|clinicalTrials=The following adverse reaction can occur after administration of rezafungin:
=GASTROINTESTINAL=
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
=METABOLISM AND NUTRITION DISORDER=
Anemia, Disseminated Intravascular Coagulation.
=NERVOUS SYSTEM=
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|postmarketing=The following adverse reaction can occur after administration of rezafungin:
=GASTROINTESTINAL=
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
=METABOLISM AND NUTRITION DISORDER=
Anemia, Disseminated Intravascular Coagulation.
=NERVOUS SYSTEM=
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|drugInteractions=Rezafungin is not a substrate of CYP enzymes or drug transporter systems. Rezafungin is not an inhibitor or inducer of common drug metabolizing CYP enzymes or transporter systems.
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=Clinical studies of Rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInGender=Clinical studies of rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInRenalImpair=No clinically relevant effect on the pharmacokinetics of rezafungin were observed based on renal impairment (creatinine clearance: 9.3 mL/min to above 120 mL/min) and no effect is expected in patients undergoing hemodialysis.
|useInHepaticImpair=No clinically relevant effects on the pharmacokinetics of rezafungin were observed with hepatic impairment (Child Pugh Class B or C).
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|administration=Administer Rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|overdose=No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
|mechAction=Rezafungin is a semi-synthetic echinocandin. Rezafungin inhibits the 1,3-β-D-glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall of many fungi, including Candida species (spp.). Inhibition of 1,3-β-D-glucan synthesis results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown.
|structure=REZZAYO (rezafungin for injection), for intravenous use is a sterile solid (cake or powder) that contains rezafungin acetate. Rezafungin acetate is a semisynthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. REZZAYO is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. REZZAYO contains 210 mg of rezafungin acetate, equivalent to 200 mg of rezafungin. REZZAYO also contains 47 mg histidine, 500 mg mannitol, 450 mg polysorbate 80, and hydrochloric acid and/or sodium hydroxide for pH adjustment. Rezafungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water, soluble in methanol, and sparingly soluble in ethanol. Rezafungin acetate is chemically designated as Echinocandin B, 1-[(4R,5R)-4-hydroxy-N2-[[4"- (pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4S)-4- hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]-, acetate (1:1). The empirical formula of Rezafungin acetate is C63H85N8O17 • C2H3O2, and the formula weight is 1285.46 g/mol.
|PD=Rezafungin exposures achieved with the recommended dosage regimen appear to be on the plateau of the observed flat exposure-efficacy response curve in clinical studies. Rezafungin does not prolong the QTc interval to any clinically relevant extent at a dose 3.5 times the maximum approved recommended loading dose.
|PK=Following single and multiple dosing, the Cmax and AUC of rezafungin increase in a dose-proportional manner over a dose range of 50 mg (0.125 times the approved maximum recommended loading dose) to 400 mg.
|nonClinToxic==CARCINOGENESIS=
Carcinogenicity studies with rezafungin have not been conducted.
=MUTAGENESIS=
Rezafungin was negative in a standard battery of assays, including an in vitro bacterial reverse mutation assay, an in vitro mammalian clastogenicity assay, and an in vivo rat bone marrow micronucleus assay.
=IMPAIRMENT OF FERTILITY=
Rezafungin did not affect mating or fertility in male and female rats following IV administration once every 3 days at doses up to 45 mg/kg (6 times the clinical exposure, based on AUC determined in a separate rat study). Decreased sperm motility was noted at ≥30 mg/kg and most males at 45 mg/kg showed mild/moderate hypospermia and had no detectable motile sperm. At rezafungin doses ≥30 mg/kg there was an increased incidence of sperm with abnormal morphology as well as mild to moderate degeneration of the seminiferous tubules. In a 3-month study of every 3 day IV rezafungin in rats, males dosed at 45 mg/kg showed minimal tubular degeneration/atrophy in the testes and cellular debris in the epididymides at the end of 3 months. The incidence of this finding reduced by the end of a 4-week reversibility period. In contrast, sperm concentration, production rate, morphology and motility were unaffected in adult monkeys dosed weekly with rezafungin, up to 30 mg/kg (about 6 times the clinical dose based on AUC comparisons) for 11 or 22 weeks or after a 52-week recovery period.
|clinicalStudies=The safety and efficacy of REZZAYO in the treatment of patients with candidemia and/or invasive candidiasis (IC) were evaluated in a multicenter, randomized, double-blind study (Trial 1; NCT03667690). Patients were randomized in a 1:1 ratio to receive REZZAYO or caspofungin. Randomization was stratified based on diagnosis (candidemia only; IC) and by Acute Physiology and Chronic Health Evaluation II score (APACHE II)/absolute neutrophil count (ANC) at screening. Patients with septic arthritis in a prosthetic joint, osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection, chronic disseminated candidiasis, or urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract were excluded.

Patients in the REZZAYO arm were to receive a single 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of two to four doses. Patients in the caspofungin arm were to receive a single 70 mg IV loading dose, followed by caspofungin 50 mg IV once daily treatment for a total of 2 to 4 weeks. After ≥3 days of IV therapy, patients in the caspofungin group could be switched to oral step-down therapy (fluconazole), if the patient met the criteria for cure and was preparing to be discharged.

One hundred and ninety-nine patients in the intent-to-treat (ITT) population were randomized. The age range was 19-91 years, the gender distribution was 62% male and 38% female, and the race distribution was 61% White, 5% Black, 29% Asian, and 5% other races or not reported. The median duration of therapy was 14 days in the two treatment arms.

The modified ITT (mITT) population included 187 patients with a culture positive for Candida species within 4 days before randomization and who received at least one dose of study drug. The most frequent species isolated at baseline was C. albicans (42%), followed by C. glabrata (26%), C. tropicalis (20%), and C. parapsilosis (13%). The majority (70%) of patients had a diagnosis of candidemia only. The majority (93%) of patients were not neutropenic (ANC ≥500) and 84% had APACHE II scores less than 20. Risk factors for candidemia were: receipt of broad-spectrum antibacterial drugs (71%), presence of a central venous catheter (60%), major surgery (35%), diabetes mellitus (29%), active malignancy (25%), and total parenteral nutrition (20%). Mechanically ventilated patients were 24% (17% and 30% in the REZZAYO and caspofungin group, respectively).

Efficacy was assessed by all-cause mortality at Day 30. The number and percentage of patients in each treatment group who were alive and deceased/unknown survival status at Day 30 was determined in the mITT population. Additional efficacy outcomes were global cure (mycological eradication/presumed eradication, clinical cure, and radiological cure [for patients with documented IC by radiologic or other imaging findings at baseline]), mycological eradication/presumed eradication, and investigator’s assessment of clinical cure.
|howSupplied=Rezafungin is supplied as a single-dose vial containing 200 mg of Rezafungin. For the 400 mg dose, aseptically reconstitute two vials each with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL in each vial. For the 200 mg dose, aseptically reconstitute one vial with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL
|storage=Store Rezafungin infusion solution between 5°C to 25°C (41°F to 77°F). Stability of the infusion solution has been demonstrated for 48 hours at 5°C to 25°C (41°F to 77°F).
|brandNames=REZZAYO
}}

Rezafungin

2024-03-14T06:29:56Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|OTC=Yes
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=ANTIFUNGAL ECHINOCANDIN
|indicationType=treatment
|indication=patients with invasive candidiasis and candidemia who are at least 18 years old and have few or no other options for treatment.
|adverseReactions=Diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=The recommended dosage of rezafungin is once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of rezafungin has not been established beyond 4 weekly doses. Rezafungin is used for intravenous infusion only. Administer rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|clinicalTrials=The following adverse reaction can occur after administration of rezafungin:
=GASTROINTESTINAL=
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
=METABOLISM AND NUTRITION DISORDER=
Anemia, Disseminated Intravascular Coagulation.
=NERVOUS SYSTEM=
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|useInPregnancyFDA=There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
|useInNursing=There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGender=Clinical studies of rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|overdose=No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
|brandNames=REZZAYO
}}

Rezafungin

2024-03-12T11:51:44Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-12T11:50:48Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-12T11:49:55Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-12T11:46:51Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-12T11:45:16Z

Hafiza Amna Qadeer:

Rezafungin

2024-03-12T10:23:14Z

Hafiza Amna Qadeer: Blanked the page

Rezafungin

2024-03-12T10:18:15Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|OTC=
|genericName=REZAFUNGIN
|aOrAn=AN
|drugClass=ANTIFUNGAL ECHINOCANDIN
|indicationType=TREATMENT
}}

Rezafungin

2024-03-12T10:13:09Z

Hafiza Amna Qadeer:

{{DrugProjectFormSinglePage
|authorTag=
|OTC=
|genericName=
|aOrAn=
|drugClass=
|indicationType=
}}

Rezafungin

2024-03-12T10:01:07Z

Hafiza Amna Qadeer: Created page with "{{DrugProjectFormSinglePage |authorTag=HAFIZA AMNA QADEER |OTC=Yes |genericName=REZAFUNGIN |aOrAn=an |drugClass=echinocandin antifungal |indicationType=treatment }}"

{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER
|OTC=Yes
|genericName=REZAFUNGIN
|aOrAn=an
|drugClass=echinocandin antifungal
|indicationType=treatment
}}