Becaplermin (brand name Regranex) is a cicatrizant, available as a topical gel. Regranex is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ulcers.
The reference site for Becaplermin
WHAT IS Becaplermin?
Becaplermin is used to treat ulcers of the foot, ankle, or leg in patients with diabetes.
This medicine is a human platelet-derived growth factor, a substance naturally produced by the body that helps in wound healing. It works, in combination with good ulcer care (cleaning, pressure relief, and infection control), by bringing the cells that the body uses to repair wounds to the site of the ulcer.
Brand Name(s): Regranex
CAS nº: 165101-51-9
The sections below will provide you with more specific information and guidelines related to becaplermin and its correct use. Please read them carefully.
Becaplermin is the first drug that can be applied directly to the ulcer that is designed to promote healing. It was approved by the FDA in December 1997.
Please visit the official site of the FDA for further information.
Why is this medication prescribed?
Becaplermin is a gel applied topically to diabetic ulcers in the lower limbs (foot, ankle, and leg) to promote healing of the ulcers.
It belongs to a class of drugs called platelet-derived growth factors or PDGFs. Designed to mimic naturally-occurring PDGF, becaplermin is man-made using recombinant DNA technology. Becaplermin, or as it also is known, recombinant human PDGF (rhPDGF-BB), is active early in the process of ulcer healing. Wound and ulcer healing is a three-phased process that the body initiates after an injury to the skin occurs.
The process begins with the first phase, inflammation. In this phase, blood flow and fluid increase around the site of the ulcer. If there is bleeding from injured blood vessels, platelets from the blood invade the site of the ulcer and cause the blood to clot. This stops the bleeding. Platelets also release chemical messengers (proteins) called platelet-derived growth factors (PDGFs). These PDGFs send signals to cells around the ulcer and recruit them to the site of the ulcer where they initiate the second phase of the healing process, called proliferation. In this phase scar tissue forms, and the remaining cells of the normal skin divide and produce new cells to replaced the damaged cells.
Diabetic ulcers heal slowly and sometimes not at all because the healing process is impaired, probably because blood flow to the skin is reduced in diabetics. This can lead to serious bacterial infections within the ulcers which can spread and necessitate amputation of the foot or leg. Becaplermin acts along with naturally-occurring PDGF to expedite the recruitment of cells to the ulcer. It promotes the division of cells and the formation of new skin.
Remodeling, the third and final phase of wound healing, restructures the healed ulcer, and the scar tissue that has formed is broken down. As a result of remodeling, the new skin assumes the appearance of the old skin.
Other uses for this medicine
This medication has not been approved for any alternative uses other than those mentioned in the product information section.
Dosage and using this medicine
Becaplermin comes as a gel that is to be applied directly to the skin, on a daily basis. Your doctor or wound caregiver will tell you how much becaplermin gel to apply.
The amount of gel to apply depends on the size of the ulcer. The amount you apply may be changed every 1 or 2 weeks as your ulcer heals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
It is important that you use becaplermin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Using more gel than your doctor prescribes will not make your ulcer heal faster.
To apply becaplermin gel, follow these steps:
– wash your hands thoroughly. - squeeze the amount of gel your doctor has told you to use onto a clean, non-absorbent surface such as wax paper. The tip of the tube should not come in contact with the ulcer or any other surface. Recap the tube tightly after use. - with a clean cotton swab, tongue depressor, or other applicator, spread the gel over the ulcer surface in an even layer about 1/16th of an inch thick. - moisten a piece of gauze dressing with saline (salt water) and cover the ulcer with the dressing. - after about 12 hours, remove the gauze dressing and rinse the ulcer gently with saline or water to remove whatever gel is left. - cover the ulcer with a gauze dressing moistened with saline. This drug must be used for a few weeks before your ulcer begins to heal. You may need to use becaplermin for up to 20 weeks.
This drug must be used in combination with a good ulcer care program, including a strict non-weight-bearing program and good cleaning practices.
What special precautions should I follow?
BEFORE TAKING FLUOXETINE:
Tell your doctor and pharmacist if you are allergic to becaplermin, parabens, or any other drugs. Be sure to inform your doctor and pharmacist what prescription and non-prescription medications you are taking, especially other topical medications applied to the ulcer and vitamins and herbal products. Tell your doctor if you have or have ever had a cancerous growth at the site of the ulcer. Moreover, let you doctor know if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using becaplermin, call your doctor.
What should I do if I forget a dose?
Apply the missed dose as soon as you remember it. However, if it is almost time for the next application, skip the missed application and continue your regular application schedule.
Do not apply a double amount of gel to make up for a missed application.
What side effects can this medication cause?
Becaplermin is well tolerated. In studies, about 2% of patients using becaplermin or a placebo gel alone developed a rash as compared to no rashes with good ulcer care alone. Thus, the rash probably is due to the preservatives (methylparabens, proylparabens, or m-cresol) rather than the rhPDGF-BB in the Regranex® cream.
If a rash occurs, the medical personnel who are supervising the ulcer care should be contacted.
What storage conditions are needed for this medicine?
Always keep this medication in the refrigerator, tightly closed, and out of reach of children. Do not freeze it.
Remember not to use the gel after the expiration date at the bottom of the tube. It is advised that you throw away any medication that is outdated or no longer needed. If you have any questions, please talk with your pharmacist about the proper disposal of your medication.
In case of an emergency/overdose
An overdose of becaplermin topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that becaplermin topical has been ingested, call your local poison control center on 1-800-222-1222.
However, if the victim has collapsed or is not breathing, call the local emergency services on 911.
PICTURES OF BECAPLERMIN PILLS
Below you will find images and specific information on the principal types of becaplermin that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.
The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.
Imprint: REGRANEX GEL
Manufacturer: ORTHO-MCNEIL PHARM.