Olipudase alfa
Generic name: olipudase alfa [ oh-LIP-ue-dase-AL-fa ]
Brand name: Xenpozyme
Dosage form: intravenous powder for injection (rpcp 20 mg; rpcp 4 mg)
Drug class: Lysosomal enzymes
What is olipudase alfa?
Olipudase alfa is used to treat people with a genetic disorder called acid sphingomyelinase deficiency (ASMD).
Olipudase alfa may also be used for purposes not listed in this medication guide.
Olipudase alfa side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Olipudase alfa may cause serious side effects. Call your doctor at once if you have:
-
liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects of olipudase alfa may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
Before taking this medicine
Tell your doctor if you have or have ever had:
May harm an unborn baby. Use effective birth control while using olipudase alfa and for at least 14 days after your last dose. Tell your doctor if you become pregnant.
You may need to have a negative pregnancy test before starting this treatment.
Ask a doctor if it is safe to breastfeed while using olipudase alfa.
How is olipudase alfa given?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Olipudase alfa is injected into a vein. Ask your doctor or pharmacist if you don't understand how to use an injection.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Doses are based on weight. Your dose may change if you gain or lose weight.
You will be watched for a short time to make sure you do not have an allergic reaction.
You will need frequent blood tests to check your liver function.
Follow all storage instructions provided with olipudase alfa. Your pharmacist can provide more information about how to store this medicine.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include fever, feeling like you might pass out, bloody or tarry stools, nausea, coughing up blood or vomit that looks like coffee grounds, loss of appetite, dark urine, confusion, lack of energy, irregular heartbeats, breathing problems.
What should I avoid while receiving olipudase alfa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect olipudase alfa?
Other drugs may affect olipudase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Olipudase alfa Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for olipudase alfa.
Xenpozyme (olipudase alfa-rpcp) - Genzyme Corporation
Formulation type | Strength |
---|---|
Single-Dose Vial | 20 mg |
Single-Dose Vial | 4 mg |
View Xenpozyme information in detail.
Popular FAQ
How effective is Xenpozyme?
Treatment with Xenpozyme is effective in adults and children and can significantly improve lung function, reduce liver and spleen size, and increase platelet counts. It can also improve lipid profiles and growth in children.
Clinical trial results show that Xenpozyme starts working by week 26 of treatment. After 26 weeks of treatment with Xenpozyme, significant improvements in a range of measures were noted during clinical studies and levels of sphingomyelin were decreased. Continue reading
More about olipudase alfa
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: lysosomal enzymes
- Breastfeeding
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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