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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.

About Diabetes

The number of people with diabetes is increasing in both the
United States and around the world. Diabetes currently
affects nearly 26 million Americans.

What is diabetes?

Diabetes is a condition that causes too much sugar (also called glucose) to stay in your bloodstream. This high blood sugar can damage many parts of the body, such as the heart, blood vessels, nerves, eyes, and kidneys.

Foot complications

Diabetes and high blood sugar can lead to foot problems in 2 ways:

  • Nerve damage (also called neuropathy) can lead to loss of feeling in your feet and legs. Because of nerve damage, you may not feel cuts or sores, making it easy for them to become infected.
  • Poor circulation in your feet and legs is caused by narrowing of blood vessels (also called peripheral artery disease or PAD). Because your vessels aren't bringing enough blood with oxygen and nutrients, your body will be slow to fight off an infection and heal.

Complications with nerve damage and poor circulation put you at higher risk for 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.

  • 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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