Becaplermin, rh-PDGF skin gel

What is this medication?

BECAPLERMIN (be KAP ler min) is used on the skin to treat ulcers on the lower legs in patients with diabetes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Regranex

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer at the site of the ulcer
• Wounds that are closed by your care team
• Wounds that show exposed joints, tendons, ligaments, or bone
• An unusual or allergic reaction to becaplermin, parabens, metacresol, or other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medicine is for external use only. Follow the directions on the prescription label. Wash your hands before use. Squeeze the prescribed amount of gel onto a clean, non-absorbable surface like wax paper. With a cotton swab, tongue depressor, or a similar application aid, spread an even layer of the gel over the ulcer. Cover the ulcer with a saline-moistened gauze dressing. After 12 hours, remove the gauze dressing and rinse the ulcer with saline or water to remove excess gel. Apply a new piece of saline-moistened gauze dressing to the ulcer. Do not use your medicine more often than directed. Finish the full course of medicine prescribed by your doctor or health care professional even if you think your condition is better.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the treated area without asking care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Your care team may change your dose weekly or every other week as the size of your ulcer changes. If your skin ulcer does not get smaller in 10 weeks or does not get better after 20 weeks, ask your care team if you should continue using this medication.

This medication works best when used with other methods for good skin ulcer care, such as not bearing weight on the leg that has the skin ulcer.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skinSide effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
• Mild skin irritation, redness, or dryness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Throw away any unused portion after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.