Becaplermin Topical

IMPORTANT WARNING:

Becaplermin gel is used as part of a total treatment program to help heal ulcers (sores) of the foot, ankle, or leg in people who have diabetes. Becaplermin gel must be used along with good ulcer care including: removal of dead tissue by a medical professional; the use of special shoes, walkers, crutches, or wheelchairs to keep weight off the ulcer; and treatment of any infections that develop. Becaplermin cannot be used to treat ulcers that have been stitched or stapled. Becaplermin is a human platelet-derived growth factor, a substance naturally produced by the body that helps in wound healing. It works by helping to repair and replace dead skin and other tissues, attracting cells that repair wounds, and helping to close and heal the ulcer.

Becaplermin comes as a gel to apply to the skin. It is usually applied once a day to the ulcer. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use becaplermin gel 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 prescribed will not help your ulcer heal faster.

Your doctor will show you how to measure becaplermin gel and will tell you how much gel to apply. The amount of gel you will need depends on the size of your ulcer. Your doctor will examine your ulcer every 1-2 weeks, and may tell you to use less gel as your ulcer heals and grows smaller.

It may take up to 20 weeks for you to feel the full benefit of becaplermin gel. Continue to use becaplermin gel for as long as it is prescribed by your doctor, even if your ulcer appears to be healed. Your doctor will tell you when your ulcer is completely healed and no longer needs treatment with becaplermin gel.

Becaplermin gel is for use on the skin only. Do not swallow the medication. Do not apply the medication to any part of your body other than the ulcer that is being treated.

To apply becaplermin gel, follow these steps:

1. Wash your hands thoroughly.

2. Gently rinse the wound with water. Wash your hands again.

3. Squeeze the length of gel your doctor has told you to use onto a clean, non-absorbent surface such as wax paper. Do not touch the tip of the tube to the wax paper, the ulcer, or any other surface. Recap the tube tightly after use.

4. Use a clean cotton swab, tongue depressor, or other applicator to spread the gel over the ulcer surface in an even layer about 1/16th of an inch (0.2 centimeters) thick.

5. Moisten a piece of gauze dressing with saline and place it on the wound. The gauze should cover only the wound, not the skin around it.

6. Place a small, dry pad dressing over the wound. Wrap a soft, dry gauze bandage over the pad and hold it in place with adhesive tape. Be careful not to attach the adhesive tape to your skin.

7. After about 12 hours, remove the bandage and gauze dressing and rinse the ulcer gently with saline or water to remove whatever gel is left.

8. Bandage the ulcer following the instructions in steps 5 and 6. Do not reuse the gauze, dressing, or bandage that you removed before washing the ulcer. Use fresh supplies.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using becaplermin gel,

• tell your doctor and pharmacist if you are allergic to becaplermin, any other medications, or parabens.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional products and herbal supplements you are taking or plan to take. Be sure to mention other medications that are applied to the ulcer.
• tell your doctor if you have or have ever had the condition mentioned in the IMPORTANT WARNING section.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using becaplermin gel, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed application and continue your regular application schedule. Do not apply extra gel to make up for a missed application.

Becaplermin gel may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• rash

Becaplermin gel may cause other side effects. Tell your doctor if you have any unusual problems while you are using this medication.

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/Safety/MedWatch] or by phone [1-800-332-1088].

Keep this medication in the container it came in tightly closed, and out of reach of children. Keep it in the refrigerator at all times but do not freeze it. Do not use the gel after the expiration date marked 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.

Keep all appointments with your doctor.

Do not let anyone else use 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.

Last Reviewed - 02/01/2009