elapegademase

What is the most important information I should know about elapegademase?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is elapegademase?

Elapegademase is a man-made form of an enzyme called adenosine deaminase (ADA). ADA is important in the body for preventing the buildup of certain proteins harmful to the white blood cells that help your body fight infections.

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

ADA-SCID is a lack of immunity to infections that might not cause illness in someone with a healthy immune system. Certain infections (such as pneumonia, chronic diarrhea, or serious skin rash) can be serious or even fatal in people with ADA-SCID.

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

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

What should I discuss with my healthcare provider before using elapegademase?

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.

How is elapegademase given?

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.

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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using elapegademase?

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.

What are the possible side effects of elapegademase?

• 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.

• 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 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.

What other drugs will affect elapegademase?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about elapegademase.