Elapegademase

Elapegademase is a man-made version of an enzyme called adenosine deaminase (ADA). ADA is important for preventing harmful proteins from building up, which can affect the white blood cells that help your body fight infections.

Elapegademase is used to replace ADA in adults and children who have adenosine deaminase severe combined immune deficiency (ADA-SCID).

ADA-SCID means there is a lack of immunity to infections that might not make a person with a healthy immune system sick. Certain infections (like pneumonia, chronic diarrhea, or serious skin rash) can be very serious or even deadly for people with ADA-SCID.

ADA-SCID can also slow the growth or development of an infant or young child with this condition.

Elapegademase may also be used for other purposes not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Tell your doctor if you have ever used a medication called Adagen (pegademase bovine).

Also tell your doctor if you have had severe thrombocytopenia (low levels of platelets in blood).

Your doctor should check your progress on a regular basis if you use elapegademase during pregnancy.

It may not be safe to breast-feed while using elapegademase. Ask your doctor about any risk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Elapegademase may cause serious side effects. Call your doctor immediately if you have:

• bleeding where the medicine was injected;
• other unusual bleeding (nosebleeds, bleeding gums);
• a seizure; or
• pale or yellowed skin, dark colored urine; or
• confusion or weakness.

The following symptoms may be signs of infection, which may indicate that elapegademase is not an effective treatment for you. Tell your doctor if you have:

• fever, chills, unusual tiredness;
• sore throat, sinus pain, swollen glands;
• skin warmth or swelling;
• stomach cramps, vomiting, or diarrhea;
• blood in your urine or stools;
• painful or difficult urination;
• breathing problems, cough with mucus;
• sores or white patches in your mouth or on your skin;
• problems with balance or walking; or
• problems with your teeth or gums.

Common side effects of elapegademase may include:

• vomiting; or
• cough.

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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Elapegademase is injected into a muscle. A healthcare provider can teach you how to properly use the medication by yourself.

Elapegademase is usually given once every 7 days. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Elapegademase doses are based on weight. Your dose needs may change if you gain or lose weight.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

It may take 2 to 6 months before you receive the full benefit of using elapegademase. Keep using the medication regularly to get the most benefit.

Do not shake the medication bottle or you may ruin the medicine.

Store in the refrigerator, do not freeze. Throw away the medicine if it has become frozen.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

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.

• Avoid being near people who are sick or have infections.
• Tell your doctor at once if you develop signs of infection.

• Avoid activities that may increase your risk of bleeding or injury.
• Use extra care to prevent bleeding while shaving or brushing your teeth.

Other drugs may affect elapegademase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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