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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.

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General

Smith & Nephew PLC, registered office 15 Adam St, London, United Kingdom, WC2N 6LA, is a holding company and is not an operating company. Therefore, products and services are provided exclusively by subsidiaries and not by Smith & Nephew PLC. "Smith & Nephew" may refer to Smith & Nephew PLC itself or one or more of its subsidiaries.

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This statement was last updated on 15 May 2012.

Copyright © 2012 Smith & Nephew

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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