• What is REGRANEX Gel?

    REGRANEX Gel is the only medicine of its kind approved by the Food and Drug Administration (FDA) for the treatment of diabetic foot sores. REGRANEX Gel is a human-derived protein medicine that is used with other practices (such as good wound care) to treat diabetic sores on your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs.

    • It is not known if REGRANEX Gel is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation)
    • It is not known if REGRANEX Gel is safe and effective in children under 16 years of age
  • What is the most important information I should know about REGRANEX Gel?

    You should discuss the potential benefits and risks of REGRANEX Gel with your doctor. People who use three or more tubes of REGRANEX Gel may have an increased risk of death from cancer.

    • You should talk with your doctor about the possible benefits and risks to you if you use more than three tubes of REGRANEX Gel
    • If you already have cancer, you and your doctor should carefully consider whether you will use REGRANEX Gel
  • What should I tell my doctor before starting REGRANEX Gel?

    Before you use REGRANEX Gel, tell your doctor if you:

    • Have or have had cancer
    • Have poor blood flow to your lower legs and feet
    • Have allergies to any of the ingredients in REGRANEX Gel (ask your doctor for a complete list)
    • Have any other medical conditions
    • Are pregnant or plan to become pregnant, because it is not known if REGRANEX Gel will harm your unborn baby
    • Are breastfeeding or plan to breastfeed, because it is not known if REGRANEX Gel passes into your breast milk
    • Tell your healthcare provider about all the medicines you take. These include prescription and non-prescription medicines, vitamins, and herbal supplements. It is especially important to tell your doctor if you apply any other medicines to the sores on your feet.
  • What are the possible side effects of REGRANEX Gel?

    REGRANEX Gel may cause serious side effects. Common side effects of REGRANEX Gel include:

    • Red skin rash
    • Burning at the application site

    Tell your doctor if you have any side effects that bother you or do not go away. These are not all the possible side effects of REGRANEX Gel. For more information, ask 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. You may also report side effects to Smith & Nephew at 1-800-441-8227.

  • Is REGRANEX Gel covered by insurance?

    REGRANEX Gel is covered under many prescription drug plans (including most Medicare Part D plans and many state Medicaid plans). Your insurance company may need a prior authorization before it will cover the cost of a prescription for REGRANEX Gel. Click here for more information.

  • What is a “prior authorization”?

    A prior authorization means that an insurance provider must approve a prescription before it is filled at the pharmacy. Check with your insurance provider to see if you will need a prior authorization for your REGRANEX Gel prescription. If a prior authorization is required, simply call your doctor so that he or she can contact your insurance provider, or you can click here for support from Regranex360.

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Diabetes and foot wound problems

The effects of diabetes can slow wound healing anywhere on the body. Small cuts and blisters can easily develop into deep sores.

Learn about diabetic foot sores
Important Safety Information

People who use 3 or more tubes of REGRANEX (becaplermin) Gel may have an increased risk of death from cancer.

REGRANEX Gel is a man-made protein medicine that is used with other ulcer care practices (such as good wound care) to treat diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs.

Do not use REGRANEX Gel if you have a skin tumor at the area where you apply the product.

Before you use REGRANEX Gel, tell your healthcare provider if you:

If you decide to use REGRANEX Gel, use the product exactly as your healthcare provider tells you to use it. This includes following your healthcare provider's instructions about not putting weight on the affected leg and foot (non-weight bearing).

Keep REGRANEX Gel and all medicines out of the reach of children. Do not use REGRANEX Gel for a condition for which it was not prescribed. Do not give REGRANEX Gel to other people, even if they have the same symptoms that you have. It may harm them.

Read the Medication Guide before you start using REGRANEX Gel and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important Safety Information

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX (becaplermin) Gel, 0.01% in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.

Important Safety Information

People who use 3 or more tubes of REGRANEX (becaplermin) Gel may have an increased risk of death from cancer.

You should talk with your healthcare provider about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX Gel. If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX Gel.