Elapegademase injection

What is this medication?

ELAPEGADEMASE (EL a peg AD e mase) is a drug that is used to replace an enzyme that is missing in patients with severe combined immunodeficiency disease associated with adenosine deaminase deficiency. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): REVCOVI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• infection
• low blood platelet counts
• an unusual or allergic reaction to elapegademase, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or healthcare professional if you are unable to keep an appointment. If you give yourself this medicine at home and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your healthcare professional for regular check ups on your progress. You will need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs and symptoms of infection like fever; chills; sore throat; pain when urinating
• signs and symptoms of low red blood cells or anemia such as unusually weak or tired; feeling faint or lightheaded; falls; breathing problems

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• cough
• pain, redness, or irritation at site where injected
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

If you are using this medicine at home, store it in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.