HCP Site

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.

Terms of Use

These terms and conditions apply when you use our website. By using this website, you are deemed to agree to these terms and conditions. If you do not agree to abide by all of these terms, please do not visit our website.

Smith & Nephew provides this website for your general information only, and we reserve the right to delete, modify or supplement the content of this website (including these terms) at any time for any reason without notification to anyone.

We do our best to ensure that the information on this website is accurate and helpful at all times. However, we cannot ultimately warrant the accuracy of that information and so we cannot be held liable for any use or reliance you may make of or put on it.

The information on this website is time-based, and may well no longer be an accurate reflection of our current position.

Nothing on this website should be construed as an offer to provide any service to you. No offer to contract shall be provided by us from this website, and any offer must be signed by an officer of the company.

Contributions

Other than those circumstances described in the Privacy Policy on this website, any contributions you send to this website are on a non-confidential basis, and we are under no obligation to refrain from reproducing, publishing, or otherwise using them in any way or for any purpose. That means that Smith & Nephew shall be free to use the content of any such communications, including any ideas, inventions, concepts, techniques or know-how disclosed therein, for any purpose without compensation or attribution to you, including developing, manufacturing and/or marketing goods or services.

So please do NOT submit any confidential information to us; anything you submit will not be held in confidence, but will be treated as publicly-available information.

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Smith & Nephew makes no representations, warranties or assurances as to the availability, accuracy, currency or completeness of this website or its contents. We shall not be liable for any damages or injury resulting from your access to, or inability to access this website, or from your reliance on any information provided at this website.

Unless otherwise noted, product labelling is for the country shown. Products shown may not be available in all countries or may be known by a different name. Indications for use may vary from country to country. You should always check with your local health care professional and/or read the package insert prior to use. Customer Service is available to help with product information or questions. The information provided here is not a substitute for medical care. If you have or suspect you have a health problem, you should consult your health care professional.

We will not be liable for any loss, damage, expense, costs, delays or other liability whatsoever (including without limitation any financial losses such as loss of profit) which you may incur as a result of any event (including without limitation any failure of transmission, communication, computer or other facilities or your inability to access the website for any reason or any failure, error or delay in the sending or receiving of any notice or communication or instruction through the post or any electronic medium).

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With the exception of websites under our control, if this website is linked to from other websites, or if other websites are linked to from this website, Smith & Nephew does not endorse or have any responsibility for the content of such other websites, and Smith & Nephew shall not be liable for any damages or injury arising from the content of any other website.

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If you wish to make any use of material on our website other than that set out above, please address your request to enquiries@smith-nephew.com

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.

With the exception of websites under our control, if this website is linked to from other websites, or if other websites are linked to from this website, Smith & Nephew does not endorse or have any responsibility for the content of such other websites, and Smith & Nephew shall not be liable for any damages or injury arising from the content (or the use of your data) of any other website.

This statement is subject to change, and Smith & Nephew will not proactively notify you of any such changes. It is your responsibility to ensure you visit this web page regularly to review any changes that may have been made since your previous visit.

This agreement shall be governed by the laws of the state of Tennessee and any disputes subject to the exclusive jurisdiction of the United States of America.

This statement was last updated on 5 November 2012.

Copyright © 2013 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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