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Regranex (Becaplermin) - Summary

 
 



WARNING

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing 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. (See CONTRAINDICATIONS and WARNINGS)

 

REGRANEX SUMMARY

REGRANEX® Gel contains becaplermin, a recombinant human platelet-derived growth factor (rhPDGF-BB) 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.

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, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers (See Clinical Studies) 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.


See all Regranex indications & dosage >>

NEWS HIGHLIGHTS

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 analysis. [2010]
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...

more studies >>

Clinical Trials Related to Regranex (Becaplermin)

Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer [Recruiting]
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 Regranexļæ½ 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 elbow).

A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer [Recruiting]
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).

Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD [Recruiting]
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy

more trials >>


Page last updated: 2013-02-10

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