Xenpozyme 20 mg intravenous solution

Generic name:
Olipudase alfa - injection

Pronunciation
(oh-LIP-ue-dase)

Brand name(s)
Xenpozyme

This medication may cause very serious allergic or infusion reactions. Your doctor may prescribe other medications (such as acetaminophen, antihistamines, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of a serious allergic reaction or infusion reactions such as rash, hives, redness/itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or fever. Your doctor may slow down or stop your treatment for some time.

This medication is used to treat symptoms due to a certain inherited disorder (acid sphingomyelinase deficiency-ASMD). This condition causes buildup of a fatty substance called sphingomyelin in various parts of the body. Olipudase alfa is an enzyme that helps break down sphingomyelin. It is not a cure for ASMD, but it can help decrease some symptoms caused by this disorder such as enlarged spleen and liver.

Read the Patient Information Leaflet if available from your pharmacist before you start using olipudase alfa and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein as directed by your doctor. The first 2 doses are usually given 1 week apart, followed by injections every 2 weeks. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, weight, and response to treatment.

To get the most benefit, do not miss any doses. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Pain/redness/swelling at the infusion site, headache, muscle/joint pain, tiredness, watering eyes, itching, nausea, vomiting, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver problems (nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using olipudase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially allergic and infusion reactions.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using olipudase alfa. Olipudase alfa may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 14 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver and spleen measurements, complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.