What is Regranex used for?
Regranex is a prescription medicine that is used to treat skin ulcers.
REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae.
Becaplermin has a molecular weight of approximately 25 kD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds. REGRANEX is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection. Each gram of REGRANEX contains 100 mcg of becaplermin.
Mechanism of Action
REGRANEX has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.
Before taking Regranex, tell your doctor:
- If you are allergic to Regranex; 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 a tumor where the drug is being used.
This is not a list of all drugs or health problems that interact with this medicine.
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 Regranex 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 Regranex?
- Tell all of your health care providers that you take Regranex. This includes your doctors, nurses, pharmacists, and dentists.
- It may take several weeks to see the full effects.
- Talk with your doctor before you use other drugs or products on your skin.
- Cases of cancer have happened in some people taking Regranex. If you have questions, talk with the doctor.
- If you have cancer, talk with your doctor.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is Regranex best taken?
Use Regranex as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Do not take Regranex by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
- Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
- Do not touch the container tip to the skin.
- Squeeze the gel needed on a piece of wax paper.
- Use something like a clean cotton swab or tongue depressor to put on the ulcer.
- Spread gel over the ulcer in a thin layer.
- Cover the ulcer with a clean saline dressing for 12 hours.
- Take off the dressing after 12 hours and rinse with saline or water.
- Recover with a clean saline dressing.
- Put the cap back on after you are done using your dose.
What do I do if I miss a dose?
- Put on 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 put on 2 doses at the same time or extra doses.
What are the side effects of Regranex 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.
- Irritation where Regranex is used.
What are some other side effects of Regranex?
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:
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 Regranex?
- Store in a refrigerator. Do not freeze.
- 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SRC: NLM .