REGRANEX Gel is the first and only FDA-approved recombinant platelet-derived growth factor (PDGF) therapy for use on diabetic neuropathic ulcers.
REGRANEX (becaplermin) Gel, 0.01% contains becaplermin, a human platelet-derived growth factor that 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. REGRANEX Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices.
Endogenous platelet-derived growth factor (PDGF) is the catalyst that initiates healing by attracting repair cells to revitalize wounds1. PDGF works to stimulate fibroblast proliferation to increase granulation tissue, increase the rate of reepithelialization and revascularization and promote collagen production.2
If you are a healthcare professional in the United States and would like to learn more about REGRANEX (becaplermin) Gel, 0.01% visit www.regranex.com.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY
An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy.
Indications and usage
REGRANEX (becaplermin) Gel 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. REGRANEX Gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices.
Limitations of use
The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers
The effects of REGRANEX Gel on exposed joints, tendons, ligaments, and bone have not been established in humans
REGRANEX Gel is a non-sterile, low bioburden preserved product that should not be used in wounds that close by primary intention
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of the product (e.g. parabens)
Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use.
In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo; none occurred in patients receiving good ulcer care alone. Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX Gel.
Please see full Prescribing Information for Important Safety Information including Boxed Warning and Medication Guide (PDF)
1 Diegelmann RF, Evans MC. Wound healing: an overview of acute, fibrotic and delayed healing. Front Biosci. 2004;9:283-289.
2 Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79(4):1283-1316.