Olipudase alfa-rpcp (Intravenous)

Olipudase alfa-rpcp injection is used to treat symptoms of acid sphingomyelinase deficiency (ASMD) that do not affect the central nervous system. ASMD is a genetic condition that impacts various organs (such as the liver, lungs, spleen, blood, and stomach) and can get worse over time.

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to check your or your child's progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to look for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to confirm that you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 14 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and need immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, large swelling like hives on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Inform your doctor right away if you develop a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the usefulness of olipudase alfa-rpcp injection. It has been found safe and effective.

Geriatric

There have not been appropriate studies to determine how olipudase alfa-rpcp injection affects older adults.

Breast Feeding

There are no adequate studies on women to determine the risk to infants when using this medication during breastfeeding. You should weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if there may be an interaction. If this is the case, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain kinds of food because interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• Body aches or pain
• Chest tightness
• Confusion
• Cough
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dryness or soreness of the throat
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Hives, itching, or skin rash
• Hoarseness
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Stuffy or runny nose
• Sweating
• Tender, swollen glands in the neck
• Trouble breathing
• Trouble swallowing
• Unusual tiredness or weakness
• Voice changes

Incidence not known

• Back pain
• Chills
• Headache
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Nausea and vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• Difficulty in moving
• Flushing, redness of the skin
• Lack or loss of strength
• Muscle or joint pain
• Redness of the eye
• Sneezing
• Throat irritation
• Unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Xenpozyme

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Olipudase Alfa

Find detailed information on biosimilars for this medication.

A doctor or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle that is placed into one of your veins.

This medicine must be given slowly, so the needle will have to remain in place for at least 20 minutes. It is usually given every 2 weeks.

You may also receive medicines (eg, allergy medicine, fever medicine, steroids) to help prevent possible unwanted effects during the injection.

Missed Dose

Call your doctor or pharmacist for instructions.

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