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. [
Warnings and Precautions
REGRANEX Gel contains becaplermin, a recombinant human platelet-derived growth factor for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae. Becaplermin has a molecular weight of approximately 25 KD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds. REGRANEX Gel is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection. Each gram of REGRANEX Gel contains 100 mcg of becaplermin.
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, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.
Limitations of Use
The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see
] 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, IAET staging classification) or ischemic diabetic ulcers.
The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. [ see
REGRANEX Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.
Published Studies Related to Regranex (Becaplermin)
A matched cohort study of the risk of cancer in users of becaplermin. [2011.01]
BACKGROUND: Becaplermin is recombinant human platelet-derived growth factor for topical administration that might plausibly be related to cancer risk. Extended follow-up of patients from clinical trials of becaplermin compared with placebo identified a relative risk of cancer of 2.8 (95% confidence interval [CI], 0.6-12.8). The authors aimed to further investigate any association between becaplermin use and the occurrence of cancer by following a large cohort of patients in a clinical practice setting... CONCLUSIONS: Becaplermin does not appear to increase the risk of cancer or cancer mortality.
Benefit-risk assessment of becaplermin in the treatment of diabetic foot ulcers. [2010.06.01]
Becaplermin is a recombinant platelet-derived growth factor composed of two B chains that is approved for the treatment of neuropathic diabetic foot ulcers extending into or beyond the subcutaneous tissue in patients with adequate arterial perfusion... Finally, longer follow-up data are necessary to shed more light on the potential risk of malignancy in connection with becaplermin use.
Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture-controlling smart dressing: a randomized, multicenter, prospective analysis. [2010.05]
BACKGROUND: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound... CONCLUSIONS: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used.
Diabetic foot ulcers treated with becaplermin and TheraGauze, a
moisture-controlling smart dressing: a randomized, multicenter, prospective
over the entire surface of a wound... CONCLUSIONS: Wounds in which moisture content was regulated with TheraGauze
Treatment factors influencing the use of recombinant platelet-derived growth factor (Regranex) for head and lateral line erosion syndrome in ocean surgeonfish (Acanthurus bahianus). [2008.06]
The clinical efficacy of becaplermin (Regranex, Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey 08869) on head and lateral line erosion syndrome (HLLES) in ocean surgeonfish (Acanthurus bahianus) was examined in a two-part study to determine suitable application frequencies of the drug and the effects of the environment on outcome of treatments...
Clinical Trials Related to Regranex (Becaplermin)
The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin]) [Active, not recruiting]
The purpose of this study is to compare the risk of cancers in patients who have used
REGRANEX (becaplermin) to that of patients with similar characteristics and health issues
who have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is topical medication used
to treat non-healing neuropathic foot ulcers in patients with diabetes.
Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes [Active, not recruiting]
The purpose of this study is to evaluate risk of cancer incidence and mortality associated
with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U. S.
Veterans Health Administration.
Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer [Completed]
This is an open-label, active-control, multicentre, parallel group, randomised and
dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12. 5 µg/cm² every two
days for up to 20 weeks to becaplermin gel (Regranex® Gel 0. 01%) applied daily for up to 20
weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two
days for up to 20 weeks.
Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers [Recruiting]
The objective of this study is to compare the effectiveness and safety of windowed casts
with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment
of diabetic ulcers on the legs and feet.
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis [Recruiting]
The purpose of this study is to determine whether recombinant human platelet-derived growth
factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis
Page last updated: 2013-02-10