Becaplermin Topical

WHY is this medicine prescribed?

Becaplermin gel is used as part of a total treatment program to help heal certain 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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 to 2 weeks, and may tell you to use less gel as your ulcer heals and grows smaller.

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, nonabsorbent 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 (about as thick as a penny).
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.

What SPECIAL PRECAUTIONS should I follow?

Before using becaplermin gel,

• tell your doctor and pharmacist if you are allergic to becaplermin, parabens, any other medications, or any of the ingredients in becaplermin gel.

• 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 a skin tumor or cancer by the area that you are to apply becaplermin gel. Your doctor will probably tell you not to use becaplermin gel.

• tell your doctor if you have or have ever had poor blood flow to your legs or feet, or cancer. Talk to your doctor about the risks of using becaplermin gel.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using becaplermin gel, call your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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

• rash
• burning feeling at or near the area that you applied becaplermin gel

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What OTHER INFORMATION should I know?

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.