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Regranex (becaplermin) gel 0.01% the science behind PDGF and diabetic neuropathic ulcers mechanism of action.

Regranex Gel is the only FDAapproved plateletderived growth factor or PDGF, treatment indicated for lower extremity diabetic neuropathic ulcers as an adjunct to good ulcer care.

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Indications: REGRANEX (becaplermin) gel 0.01% (“REGRANEX”) is a prescription only medication 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, an 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 plateletderived 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 nonsterile, 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 followup period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of
REGRANEX, observed in one of three retrospective postma keting 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 FDAapproved product labeling, here: https://regranex.com/pdf/PI_Full_Vers.... You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1800FDA1088."