Uses

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.

How to use Olipudase Alfa-Rpcp 20 Mg Intravenous Solution

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 visually 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 the days on the calendar when you need to receive this medication.

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

Side Effects

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.

Warnings

This medication may cause very serious allergic or infusion reactions. To decrease your risk of serious allergic or infusion reactions, your doctor may prescribe other medications (such as acetaminophen, antihistamines, corticosteroids) for you to take before receiving each dose. Tell your doctor right away if you have symptoms such as rash, hives, redness/itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or fever. Your doctor may stop or slow down your treatment for some time if you get serious side effects.

Precautions

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 breast-feeding.

Interactions

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.

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Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes Notes

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.

Missed Dose Missed Dose

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.

Storage Storage

Store in the refrigerator away from light and moisture. Do not freeze. Do not store in the bathroom. 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.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.