Tagraxofusp-erzs: Difference between revisions
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{{ | {{DrugProjectFormSinglePage | ||
|authorTag= {{Uma}} | |||
|genericName=generic name | |||
|aOrAn=a | |||
|drugClass= monoclonal antibody | |||
|indicationType= treatment | |||
|indication= | |||
|hasBlackBoxWarning=Yes | |||
|adverseReactions= Some adverse reactions that occur in patients undergoing treatment with Tagraxofusp-erzs are [[capillary leak syndrome]], nausea, fatigue, [[peripheral edema]], [[pyrexia]], and weight gain. Some lab abnormalities that occur include decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, [[ALT]], and [[AST]]. | |||
|blackBoxWarningTitle= CAPILLARY LEAK SYNDROME | |||
|blackBoxWarningBody=<i><span style="color:#FF0000;"></span></i> | |||
*There have been fatal and life-threatening cases of Capillary Leak Syndrome | |||
*Before initiating treatment, check patient to ensure proper cardiac function and that serum albumin is greater than 3.2 g/dL | |||
*Measure Albumin levels periodically during treatment, and monitor closely after ending treatment for a period of time that is clinically instructed | |||
*Additionally, assess patients periodically and monitor carefully for signs or symptoms of CLS. Some signs and symptoms include weight gain, [[edema] (new or progressively deteriorating), [[pulmonary edema]], [[hypotension]], or[[ hemodynamic instability]] | |||
|fdaLIADAdult= | |||
====ULTOMIRIS is indicated for:==== | |||
====Limitations of Use==== | |||
====Recommended Vaccination and Prophylaxis==== | |||
====Recommended Weight-Based Dosage Regimen - PNH==== | |||
====Recommended Weight-Based Dosage Regimen - aHUS==== | |||
====Dosing Considerations==== | |||
====Preparation of ULTOMIRIS==== | |||
====Administration of ULTOMIRIS==== | |||
|offLabelAdultGuideSupport= | |||
There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label. | |||
|offLabelAdultNoGuideSupport= | |||
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label. | |||
|fdaLIADPed= | |||
There is limited information regarding ULTOMIRIS FDA-Labeled Indications and Dosage (Pediatric) in the drug label. | |||
|offLabelPedGuideSupport= | |||
There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label. | |||
|offLabelPedNoGuideSupport= | |||
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label. | |||
|contraindications= | |||
|warnings = | |||
====Serious Meningococcal Infections==== | |||
======Other Infections====== | |||
======Monitoring Disease Manifestations after ULTOMIRIS Discontinuation====== | |||
Treatment Discontinuation for PNH | |||
Treatment Discontinuation for aHUS | |||
====Infusion Reactions==== | |||
|clinicalTrials = | |||
====Paroxysmal Nocturnal Hemoglobinuria (PNH)==== | |||
====Atypical Hemolytic Uremic Syndrome (aHUS)==== | |||
====Immunogenicity==== | |||
|postmarketing= There is limited information regarding Ravulizumab Postmarketing Experience in the drug label. | |||
|drugInteractions= There is limited information regarding Ravulizumab Drug Interactions in the drug label. | |||
|useInPregnancyFDA= There are no available data on ULTOMIRIS use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. | |||
|useInLaborDelivery= The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. | |||
|useInNursing= | |||
|useInPed= The safety and efficacy of Ultomiris for the treatment of PNH in pediatric patients have not been established. | |||
|useInGeri= Clinical studies of Ultomiris did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. | |||
|useInGender= There is no FDA guidance on the use of Ultomiris with respect to specific gender populations. | |||
|useInRace= There is no FDA guidance on the use of Ultomiris with respect to specific racial populations. | |||
|useInRenalImpair= There is no FDA guidance on the use of Ultomiris in patients with renal impairment. | |||
|useInHepaticImpair= There is no FDA guidance on the use of Ultomiris in patients with hepatic impairment. | |||
|useInReproPotential= There is no FDA guidance on the use of Ultomiris in women of reproductive potentials and males. | |||
|useInImmunocomp= There is no FDA guidance one the use of Ultomiris in patients who are immunocompromised. | |||
|useInOthers=(Description) | |||
|administration= | |||
|monitoring = | |||
|overdose = | |||
|drugBox={{Drugbox2 | |||
| verifiedrevid = | |||
| IUPAC_name = | |||
| image = | |||
| drug_name = Tagraxofusp-erzs | |||
<!--Clinical data--> | |||
| tradename = Elzonris | |||
| MedlinePlus = | |||
| licence_US = | |||
| pregnancy_AU = | |||
| pregnancy_US = | |||
| legal_status = | |||
| routes_of_administration = | |||
<!--Pharmacokinetic data--> | |||
| bioavailability = | |||
| metabolism = | |||
| elimination_half-life = | |||
| excretion = | |||
<!--Identifiers--> | |||
| CAS_number_Ref = | |||
| CAS_number = 1803171-55-2 | |||
| ATC_prefix = | |||
| ATC_suffix = | |||
| PubChem = | |||
| IUPHAR_ligand = | |||
| DrugBank_Ref = | |||
| DrugBank = | |||
| ChemSpiderID_Ref = | |||
| ChemSpiderID = | |||
| UNII_Ref = | |||
| UNII = C3VX249T6L | |||
| KEGG_Ref = | |||
| KEGG = Intravenous | |||
| ChEBI_Ref = | |||
| ChEBI = | |||
| ChEMBL_Ref = | |||
| ChEMBL = | |||
<!--Chemical data--> | |||
| C= | H= | N= | O= | |||
| molecular_weight = 188303.705 Da | |||
| smiles = | |||
| InChI = | |||
| InChIKey = | |||
| StdInChI_Ref = | |||
| StdInChI = | |||
| StdInChIKey_Ref = | |||
| StdInChIKey = | |||
| melting_point = | |||
}} | |||
|mechAction= | |||
|structure= There is limited information regarding Ultomiris Structure in the drug label. | |||
|PD= | |||
*The extent and duration of the pharmacodynamic response in patients with PNH and aHUS were exposure-dependent for ULTOMIRIS. Free C5 levels of <0.5 mcg/mL were correlated with maximal intravascular hemolysis control and complete terminal complement inhibition in patients with PNH. | |||
*Complete terminal complement inhibition following initiation of ULTOMIRIS treatment led to normalization of serum LDH by week 4 in complement-inhibitor naïve patients with PNH, and maintained LDH normalization in patients previously treated with eculizumab with PNH. | |||
|PK= | |||
Ravulizumab-cwvz pharmacokinetics increase proportionally over a dose range of 200 to 5400 mg. | |||
=====Distribution===== | |||
=====Elimination===== | |||
=====Specific Populations===== | |||
|nonClinToxic= | |||
====Carcinogenesis, Mutagenesis, Impairment of Fertility==== | |||
|clinicalStudies= | |||
=====Paroxysmal Nocturnal Hemoglobinuria (PNH)===== | |||
====PNH Study 301 [ALXN1210-PNH-301; NCT02946463]==== | |||
====PNH Study 302 [ALXN1210-PNH-302; NCT03056040]==== | |||
=====Atypical Hemolytic Uremic Syndrome (aHUS) ===== | |||
====Study in Adult Patients with aHUS [ALXN1210-aHUS-311; NCT02949128]==== | |||
====Study in Pediatric Patients with aHUS [ALXN1210-aHUS-312; NCT03131219]==== | |||
|howSupplied= | |||
|storage= | |||
|packLabel= | |||
[[Image:ULTOMIRIS Drug Label ravulizumab.jpeg|none|thumb|400px|This image is provided by the National Library of Medicine.]] | |||
|fdaPatientInfo= | |||
=====Meningococcal Infection===== | |||
====Other Infections==== | |||
====Discontinuation==== | |||
====Infusion reactions==== | |||
*Advise patients that administration of ULTOMIRIS may result in infusion reactions. | |||
|nlmPatientInfo=(Link to patient information page) | |||
|lookAlike= There is limited information regarding Ultomiris Look-Alike Drug Names in the drug label. | |||
|brandNames= | |||
Elzonris | |||
|drugShortage= | |||
Drug Shortage | |||
}} |
Revision as of 05:32, 14 December 2020
{{DrugProjectFormSinglePage |authorTag= Uma Maveli[1]
|genericName=generic name |aOrAn=a |drugClass= monoclonal antibody |indicationType= treatment |indication= |hasBlackBoxWarning=Yes |adverseReactions= Some adverse reactions that occur in patients undergoing treatment with Tagraxofusp-erzs are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight gain. Some lab abnormalities that occur include decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.
|blackBoxWarningTitle= CAPILLARY LEAK SYNDROME |blackBoxWarningBody=
- There have been fatal and life-threatening cases of Capillary Leak Syndrome
- Before initiating treatment, check patient to ensure proper cardiac function and that serum albumin is greater than 3.2 g/dL
- Measure Albumin levels periodically during treatment, and monitor closely after ending treatment for a period of time that is clinically instructed
- Additionally, assess patients periodically and monitor carefully for signs or symptoms of CLS. Some signs and symptoms include weight gain, [[edema] (new or progressively deteriorating), pulmonary edema, hypotension, orhemodynamic instability
|fdaLIADAdult=
ULTOMIRIS is indicated for:
Limitations of Use
Recommended Vaccination and Prophylaxis
Recommended Weight-Based Dosage Regimen - PNH
Recommended Weight-Based Dosage Regimen - aHUS
Dosing Considerations
Preparation of ULTOMIRIS
Administration of ULTOMIRIS
|offLabelAdultGuideSupport=
There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.
|offLabelAdultNoGuideSupport=
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.
|fdaLIADPed=
There is limited information regarding ULTOMIRIS FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
|offLabelPedGuideSupport= There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.
|offLabelPedNoGuideSupport=
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.
|contraindications=
|warnings =
Serious Meningococcal Infections
Other Infections
Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
Treatment Discontinuation for PNH
Treatment Discontinuation for aHUS
Infusion Reactions
|clinicalTrials =
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Immunogenicity
|postmarketing= There is limited information regarding Ravulizumab Postmarketing Experience in the drug label.
|drugInteractions= There is limited information regarding Ravulizumab Drug Interactions in the drug label.
|useInPregnancyFDA= There are no available data on ULTOMIRIS use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. |useInLaborDelivery= The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. |useInNursing= |useInPed= The safety and efficacy of Ultomiris for the treatment of PNH in pediatric patients have not been established. |useInGeri= Clinical studies of Ultomiris did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. |useInGender= There is no FDA guidance on the use of Ultomiris with respect to specific gender populations. |useInRace= There is no FDA guidance on the use of Ultomiris with respect to specific racial populations. |useInRenalImpair= There is no FDA guidance on the use of Ultomiris in patients with renal impairment. |useInHepaticImpair= There is no FDA guidance on the use of Ultomiris in patients with hepatic impairment. |useInReproPotential= There is no FDA guidance on the use of Ultomiris in women of reproductive potentials and males. |useInImmunocomp= There is no FDA guidance one the use of Ultomiris in patients who are immunocompromised.
|useInOthers=(Description) |administration=
|monitoring =
|overdose =
|drugBox=
Tagraxofusp-erzs
| |
Systematic (IUPAC) name | |
? | |
Identifiers | |
CAS number | |
ATC code | ? |
PubChem | ? |
Chemical data | |
Formula | ? |
Mol. mass | 188303.705 Da |
Pharmacokinetic data | |
Bioavailability | ? |
Metabolism | ? |
Half life | ? |
Excretion | ? |
Therapeutic considerations | |
Pregnancy cat. |
? |
Legal status | |
Routes | ? |
|mechAction=
|structure= There is limited information regarding Ultomiris Structure in the drug label. |PD=
- The extent and duration of the pharmacodynamic response in patients with PNH and aHUS were exposure-dependent for ULTOMIRIS. Free C5 levels of <0.5 mcg/mL were correlated with maximal intravascular hemolysis control and complete terminal complement inhibition in patients with PNH.
- Complete terminal complement inhibition following initiation of ULTOMIRIS treatment led to normalization of serum LDH by week 4 in complement-inhibitor naïve patients with PNH, and maintained LDH normalization in patients previously treated with eculizumab with PNH.
|PK= Ravulizumab-cwvz pharmacokinetics increase proportionally over a dose range of 200 to 5400 mg.
Distribution
Elimination
Specific Populations
|nonClinToxic=
Carcinogenesis, Mutagenesis, Impairment of Fertility
|clinicalStudies=
Paroxysmal Nocturnal Hemoglobinuria (PNH)
PNH Study 301 [ALXN1210-PNH-301; NCT02946463]
PNH Study 302 [ALXN1210-PNH-302; NCT03056040]
Atypical Hemolytic Uremic Syndrome (aHUS)
Study in Adult Patients with aHUS [ALXN1210-aHUS-311; NCT02949128]
Study in Pediatric Patients with aHUS [ALXN1210-aHUS-312; NCT03131219]
|howSupplied=
|storage=
|packLabel=
|fdaPatientInfo=
Meningococcal Infection
Other Infections
Discontinuation
Infusion reactions
- Advise patients that administration of ULTOMIRIS may result in infusion reactions.
|nlmPatientInfo=(Link to patient information page) |lookAlike= There is limited information regarding Ultomiris Look-Alike Drug Names in the drug label.
|brandNames= Elzonris |drugShortage= Drug Shortage
}}