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 reasons not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• liver disease.

Olipudase alfa 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.

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:

• joint pain;
• hives, rash, itching;
• stuffy nose;
• headache;
• cough;
• sore throat;
• feeling like you might pass out;
• eye redness;
• fever, tiredness; or
• diarrhea, stomach pain, vomiting, nausea.

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.

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.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fever, feeling faint, bloody or black stools, nausea, coughing up blood or vomit that looks like coffee grounds, loss of appetite, dark urine, confusion, fatigue, irregular heartbeats, or trouble breathing.

Follow your doctor's instructions about any limits on food, drinks, or activities.

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.