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Important Safety Information

People who use 3 or more tubes of REGRANEX® 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. View More.

Frequently Asked
Questions (FAQs)

  • 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 man-made 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 3 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 3 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 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 Regranex360SM.

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

REGRANEX® (becaplermin) 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.

  • 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

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:

  • Have cancer
  • Have poor blood flow to your legs and feet
  • Have allergies to any of the ingredients in REGRANEX® Gel. See the Medication Guide for a complete list of ingredients
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. It is not known if REGRANEX® Gel will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if REGRANEX® Gel passes into your breast milk
  • Take any medicines (including 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

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).

  • REGRANEX® Gel is for use on skin ulcers only. Do not use REGRANEX® Gel in your mouth, eyes, or vagina
  • See the Medication Guide for more information REGRANEX® Gel may cause serious side effects
  • People who use 3 or more tubes of REGRANEX® Gel may have an increased risk of death from cancer
  • Common side effects of REGRANEX® Gel include:
    • — Red skin rash
    • — Burning at the application site
  • Tell your doctor if you have any side effect that bothers you or that does 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 the FDA at www.fda.gov/medwatch or at 1-800-FDA-1088. You may also report side effects to Smith & Nephew at 1-800-441-8227

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.

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