Rediscover

REGRANEX® Gel provides chronic wounds with daily replenishment of platelet-derived growth factor (PDGF)1:

  • The recombinant PDGF in REGRANEX Gel demonstrates biological activity similar to endogenous PDGF to revitalize chronic wounds1
    • Promotes the recruitment and proliferation of cells involved in wound repair
    • Enhances the formation of granulation tissue

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® Gel 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.

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.

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.

Reference: 1. REGRANEX Gel Prescribing Information. Healthpoint Biotherapeutics, Ltd. October 2011.

References: 1. Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. Diabetes Care. 1998;21(5):822-827. 2. Smiell JM, Wieman TJ, Steed DL, Perry BH, Sampson AR, Schwab BH. Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies. Wound Repair Regen. 1999;7(5):335-346.

Please see Full Prescribing Information, including Boxed Warning.

To report suspected adverse reactions, contact Healthpoint Biotherapeutics at 1-800-441-8227 or FDA at www.fda.gov/medwatch or at 1-800-FDA-1088.