Side Effects

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Uses

This medication is used to treat certain foot/leg ulcers in people with diabetes. It is used along with good foot/leg care (such as keeping pressure off the wound) to help the ulcer heal completely. Becaplermin works by attracting certain natural substances to the ulcer that help wound healing.

How to use Regranex Gel

Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using becaplermin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Wash hands thoroughly before applying this medicine. To avoid contaminating the container tip, do not touch it to the skin or any other surface. Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

The amount of the medication applied is based on the size of the ulcer. Your doctor or wound specialist should adjust your dose every 1 to 2 weeks.

Squeeze the prescribed amount of medication onto a clean, firm, and non-absorbent surface (such as waxed paper). Use a clean applicator (such as a cotton swab, tongue depressor) to apply a thin layer of the medication evenly over the ulcer as directed by your doctor, usually once daily.

Cover the ulcer with wound dressing as directed by your doctor. After 12 hours, remove the dressing, rinse the ulcer, and apply new dressing on the ulcer. Do not apply more medication at this time.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Use this medication until the ulcer heals completely.

Do not apply a thick layer of the medication or use more of the medication than directed. This will not increase the effects of the medication or help the wound heal faster and may increase the risk of side effects. Talk to your doctor for more details.

Tell your doctor if your condition worsens, does not improve after 10 weeks, or does not heal completely after 20 weeks.

Precautions

Before using becaplermin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as parabens), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (especially in the ulcer area).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

This medication has been prescribed for your current wound only. Do not use it later for another wound unless told to do so by your doctor. A different medication may be necessary in that case.

Good foot care can help reduce the chances of foot ulcers. Wash your feet daily and check for cuts, sores, or blisters. Keep your toenails neat and trimmed. Choose shoes that are well-fitting, and always wear socks with your shoes.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.