XENPOZYME 4 mg/1.1mL
olipudase alfa-rpcp · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Genzyme Corporation
XENPOZYME is a injection, powder, lyophilized, for solution containing olipudase alfa-rpcp at 4 mg/1.1mL, taken intravenous. Manufactured by Genzyme Corporation.
Key Facts
- Brand Name
- XENPOZYME
- Generic Name
- olipudase alfa-rpcp
- NDC Code (Product)
58468-0051- Manufacturer
- Genzyme Corporation
- Strength
- 4 mg/1.1mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761261
- Marketing Start
- 08/29/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important recommendations prior to XENPOZYME treatment initiation. ( 2.1 ) Adults: Recommended starting dose is 0.1 mg/kg administered as an intravenous infusion. ( 2.2 ) Pediatrics: Recommended starting dose is 0.03 mg/kg administered as an intravenous infusion. ( 2.3 ) See Full Prescribing Information for the recommended dose escalation and maintenance dosage, dosage modifications to reduce the risk of adverse reactions, and preparation and administration instructions. ( 2.2 , 2.3 , 2.5 , 2.6 , 2.7 ) 2.1 Important Recommendations Prior to XENPOZYME Treatment Initiation Therapy with XENPOZYME should be directed in consultation with physicians knowledgeable in the management of ASMD. In order to avoid dosing errors including overdosage [see Overdosage (10) ] , follow all instructions for dosage and administration. Laboratory Testing Before initiating XENPOZYME: Obtain baseline transaminase (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) levels in all patients within 1 month prior to treatment initiation [see Warnings and Precautions (5.3) ] . Verify pregnancy status in females of reproductive pot…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions (IARs) [see Warnings and Precautions (5.2) ] Elevated Transaminase Levels [see Warnings and Precautions (5.3) ] Most common adverse reactions in adult patients (incidence ≥10%) are headache, cough, diarrhea, hypotension, and ocular hyperemia. ( 6.1 ) Most common adverse reactions in pediatric patients (incidence ≥20%) are pyrexia, cough, diarrhea, rhinitis, abdominal pain, vomiting, headache, urticaria, nausea, rash, arthralgia, pruritus, fatigue, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety analysis from 3 clinical trials included a…
Frequently Asked Questions
What is XENPOZYME used for?
XENPOZYME contains olipudase alfa-rpcp. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is XENPOZYME a controlled substance?
XENPOZYME is not classified as a controlled substance by the DEA.
What is the generic name for XENPOZYME?
The generic name for XENPOZYME is olipudase alfa-rpcp. There are no other listed brand versions of olipudase alfa-rpcp.
What is the NDC code for XENPOZYME 4 mg/1.1mL?
The NDC (National Drug Code) for XENPOZYME 4 mg/1.1mL is 58468-0051, listed by Genzyme Corporation.
Other XENPOZYME Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)