Regranex (for the skin) is used to treat diabetic foot ulcers in people with normal blood flow in the legs and feet.

Regranex is not for use in treating pressure ulcers (bed sores) or ulcers caused by poor circulation.

Regranex may also be used for purposes not listed in this medication guide.

You should not use Regranex if you have cancer affecting the skin where you will apply Regranex.

Some people using becaplermin have developed cancer. However, it is not known whether this medicine actually causes cancer.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before applying Regranex.

Use a cotton swab, tongue depressor, or other disposable applicator to apply Regranex to your skin.

To keep the tip of the medicine tube from getting contaminated, do not allow the tip to touch any surface, including your fingers or the ulcer you are treating.

It may take several weeks before your symptoms improve. Use this medicine daily and call your doctor if your foot ulcer is not at least one-third smaller in size after 10 weeks, or if it is not completely healed after 20 weeks.

Becaplermin is only part of a complete ulcer care program that includes not putting weight on your leg and foot that is affected by an ulcer. Follow your doctor's instructions very closely.

Your doctor will need to check your foot ulcer on a regular basis.

Store the medicine in a refrigerator. Do not freeze. Keep the tube tightly capped when not in use. Do not use Regranex past the expiration date.

You should not use becaplermin if you are allergic to it, or if you have cancer affecting the skin where you will apply this medicine.

Tell your doctor if you have ever had:

• cancer; or

• blood circulation problems in your lower legs.

Some people using becaplermin have developed cancer. However, it is not known whether becaplermin actually causes cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

Regranex is not approved for use by anyone younger than 16 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of Regranex is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid putting weight on the foot affected with a diabetic ulcer.

Avoid using other medications on the areas you treat with becaplermin unless your doctor tells you to.

Avoid getting Regranex in your eyes, mouth, or vagina.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• an increase in the size of the ulcer, or worsening symptoms;

• severe itching;

• skin redness; or

• blistering or peeling skin.

Common side effects of Regranex may include:

• red rash; or

• burning where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.