Engineered for growth

REGRANEX Gel is the only FDA-approved PDGF for the treatment of diabetic neuropathic ulcers, formulated to act as a first-line treatment following effective ulcer care.

The prevalence of diabetes is rising, with an estimated 15% of patients likely to experience a diabetic foot ulcer (DFU).1-3 85% of diabetes-related lower extremity amputations are preceded by a DFU4, yet it is estimated that 85% of those amputations can be prevented.3

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How REGRANEX Gel works

Product Features

Medical Education

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Disclaimers

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") 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 including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling.

The efficacy of REGRANEX gel has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers.

The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

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Recall and Complaints

Customer will provide such support and assistance as S+N may reasonably request in the event of a general or limited voluntary or mandatory recall of the Product(s). Customer shall promptly report any complaint in respect of the Products to complaints@smith-nephew.com.

Terms & Conditions and Warranties

Citations

1. Diegelmann RF, et al. Front Biosci. 2004;9:283-289.

2. Heldin CH, et al. Physiol Rev. 1999;79:1283-1316.

3. Edmonds M, et al. Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:6-11.

4. Enoch S, et al. Wounds. 2003;15:213-229.

5. Wieman TJ, et al. Diabetes Care. 1998;21:822-827.

6. Boulton AJ. Diabetes Metab Res Rev. 2008;24 Suppl 1:S3-S6.

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