• What is REGRANEX gel?

    REGRANEX gel is a protein medicine made in yeast 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.

    • 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?

    If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX.

    • If you decide to use REGRANEX, your healthcare provider will tell you how to use REGRANEX.
  • What should I tell my doctor before starting REGRANEX gel?

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

    • Have 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. Especially tell your healthcare provider if you apply other medicines to diabetic ulcers of your legs or 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

REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.

Malignancies distant from the site of application have been reported in both a clinical study and in posmarketing use. The benefits and risks of REGRANEX gel treatment should be carefully evaluated before prescribing in patients with known malignancy.

See complete prescribing information for more details.

Important Safety Information: REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.

Important Safety Information: REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.