Elapegademase-Lvlr - Injection

Pronunciation: EL-a-peg-AD-e-mase

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

Elapegademase-lvlr is used to treat a certain inherited immune system disorder, adenosine deaminase severe combined immune deficiency (ADA-SCID). In this condition, the immune system does not work normally to fight infections. People with this disorder tend to get repeated infections that can be very serious or life-threatening. Elapegademase-lvlr is a man-made form of a substance made in your body (adenosine deaminase). It helps increase the number of blood cells that prevent and fight infection (lymphocytes).

How To Use

See also Precautions and Notes sections.

This medication is given by injection into a muscle as directed by your doctor, usually once or twice a week.

The dosage is based on your medical condition, weight, and response to treatment. Your doctor will check lab tests often to see how well it is working for you and to find your best dose.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before use, take elapegademase-lvlr out of the refrigerator. Let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) each week. It may help to mark your calendar.

Your immune system will improve slowly, usually over 2 to 6 months of treatment. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Bruising/pain at the injection site, cough, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using elapegademase-lvlr, tell your doctor or pharmacist if you are allergic to it; or to pegademase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • blood clotting problems (such as hemophilia, low blood platelets)

It may take several months before you see an effect from using elapegademase-lvlr. Even after it begins to work, you may still be more likely to get infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Elapegademase-lvlr is very similar to pegademase. Do not use pegademase while using elapegademase-lvlr.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as ADA activity, deoxyadenosine nucleotide levels, complete blood counts) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store in the original package in the refrigerator away from moisture. Do not freeze or shake. Protect from light. After using, discard the vial. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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