MedlinePlus Drug Information: Becaplermin

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Becaplermin

(be kap' ler min)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? What special precautions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[Posted 03/27/2008] The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using becaplermin (Regranex Gel) , a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using becaplermin with their patients.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex and http://www.fda.gov/cder/drug/early_comm/becaplermin.htm.

Why is this medication prescribed? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Becaplermin is used to treat ulcers of the foot, ankle, or leg in patients with diabetes. Becaplermin 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.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used? Return to top

Becaplermin comes as a gel to apply to the skin. It is usually applied once daily to the ulcer. 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. 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? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before using becaplermin,

tell your doctor and pharmacist if you are allergic to becaplermin, parabens, or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription 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.
tell your doctor 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? Return to top

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? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Side effects from becaplermin can occur. Tell your doctor if this symptom is severe or does not go away:

rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Keep this medication in the refrigerator, tightly closed, and out of reach of children. Do not freeze it. Do not use the gel after the expiration date at the bottom of the tube. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory.

Do not use becaplermin gel for other wounds or ulcers unless your doctor tells you to.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Regranex®

Last Revised - 07/01/2001
Last Reviewed - 07/01/2001

American Society of Health-System Pharmacists, Inc. Disclaimer