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Xenpozyme
Olipudase Alfa‑rpcp
$6810.00
20mg/5ml · 1 vial
BrandBranded medicine· By Sanofi
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FDA boxed warningHypersensitivity reactions including anaphylaxis
Patients treated with XENPOZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during XENPOZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to XENPOZYME may be considered.
Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment.
About Xenpozyme
Overview
Xenpozyme (olipudase alfa-rpcp) is an enzyme replacement medicine given by intravenous infusion. It treats manifestations of acid sphingomyelinase deficiency (ASMD) outside the central nervous system in adults and children. It works by supplying the enzyme that is deficient in ASMD, helping break down a fatty substance called sphingomyelin that builds up inside cells.
What it treats
Acid sphingomyelinase deficiency (ASMD) in adults and children, for manifestations outside the central nervous system.
Safety information
Side effects
Common side effects in adults include headache, cough, diarrhoea, low blood pressure and eye redness. In children, common side effects include fever, cough, diarrhoea, a runny or inflamed nose, abdominal pain, vomiting, headache, hives, nausea, rash, joint pain, itching, tiredness and a sore throat. Serious side effects include allergic reactions, including anaphylaxis, reactions associated with the infusion, and raised liver enzymes. Seek urgent medical help for anaphylaxis or a severe infusion reaction. Contact your doctor about other allergic or infusion-related reactions. Blood tests are needed to check liver enzymes. Starting treatment or increasing the dose during pregnancy may increase the risk of birth defects and is not recommended. Contact your doctor if you are pregnant or become pregnant during treatment. Use effective contraception during treatment and for 14 days after the last dose if treatment is stopped.
FDA boxed warning
Hypersensitivity reactions including anaphylaxis
Patients treated with XENPOZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during XENPOZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to XENPOZYME may be considered.
Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications to Xenpozyme. However, severe infusion-related reactions require the infusion to be stopped and appropriate medical treatment started. Liver enzymes (ALT and AST) must be checked before starting treatment, during dose escalation and before resuming treatment after a missed dose. Starting Xenpozyme or increasing the dose during pregnancy is not recommended because it may increase the risk of fetal malformations. People who can become pregnant should use effective contraception during treatment and for 14 days after the last dose if treatment is stopped.
Using Xenpozyme
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label XENPOZYME (OLIPUDASE ALFA-RPCP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] (DailyMed, retrieved 19 September 2026).
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