Elapegademase
Generic name: elapegademase
Brand name: Revcovi
Dosage form: intramuscular solution (1.6 mg/mL)
Drug class: Other immunostimulants
What is elapegademase?
Elapegademase is a prescription medicine that is used to treat severe immune deficiency due to adenosine deaminase deficiency.
Description
Elapegademase-lvlr is a recombinant adenosine deaminase (rADA) based on bovine amino acid sequence, conjugated to monomethoxypolyethylene glycol (mPEG). rADA is manufactured in E. coli and is covalently conjugated to mPEG with a succinimidyl carbamate linker to produce methoxypolyethylene glycol recombinant adenosine deaminase (SC-PEG rADA). The approximate molecular weight of elapegademase-lvlr (SC-PEG rADA) is 113 KDa.
REVCOVI (elapegademase-lvlr) injection is a sterile, preservative free, clear, colorless solution for intramuscular use supplied in single-dose vials. Each vial provides 1.5 mL of solution containing 2.4 mg elapegademase-lvlr (1.6 mg/mL), sodium chloride (12.75 mg), sodium phosphate dibasic heptahydrate (12.7 mg), sodium phosphate monobasic monohydrate (3.81 mg), and Water for Injection, USP. The pH is 6.9.
Mechanism of Action
SCID associated with a deficiency of ADA enzyme is a rare, inherited, and often fatal disease. ADA enzyme is involved in purine metabolism, catalyzing the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Maintaining a low level of 2′-deoxyadenosine and adenosine is crucial for proper number and function of immune cells as well as decreasing the frequency of opportunistic infections. Elevated adenosine levels, as occurring in ADA deficiency, contribute to apoptosis and a block in the differentiation of thymocytes, causing severe T‑lymphopenia.
Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number
Before taking elapegademase, tell your doctor:
- If you are allergic to elapegademase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have low platelet levels.
This is not a list of all drugs or health problems that interact with elapegademase.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take elapegademase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take elapegademase?
- Tell all of your health care providers that you take elapegademase. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- It may take up to 6 months for your immune system to start working better. The full effect may not be seen for longer. Keep doing what your doctor has told you to avoid infections. Tell your doctor right away if you have any new signs of infection after you start elapegademase. This includes fever, chills, sore throat, weakness, cough, shortness of breath, passing urine more often, or pain when passing urine.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using elapegademase while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is elapegademase best taken?
Use elapegademase as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into a muscle.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Do not shake.
- Before using elapegademase, take it out of the refrigerator and leave it at room temperature for 30 minutes.
- Do not heat or microwave.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not use if solution changes color.
- Do not mix with any other liquid drugs.
- Throw away any part of the opened vial not used after the shot is given.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
- Keep taking elapegademase as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss a dose, call your doctor.
What are the side effects of elapegademase that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of elapegademase?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Cough.
- Throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out elapegademase?
- Store in a refrigerator. Do not freeze.
- Do not use if it has been frozen.
- Store in the original container to protect from light.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
SRC: NLM .