becaplermin (Regranex)
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Introduction
Tradename: Regranex. Recombinant platelet-derived growth factor-beta (PDGF-beta).
Indications
- cutaneous ulcer due to diabetic neuropathy (FDA-approved)
- also useful for venous stasis ulcers
Dosage
- Apply gel to clean wound bed once a day.
- Cover with saline moistened dressing
- After 12 hours, rinse with saline or water & apply new dressing. Gel 0.01% in 2, 7.5 & 15 g tubes
Adverse effects
- systemically available PDGF < 3%
- rash (2%)
- may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel[2]
* Boxed warning removed; no increased risk[3]
Mechanism of action
- Aids in production of granulation tissue.
More general terms
References
- ↑ Ortho-McNeil Pharmaceuticals
- ↑ 2.0 2.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex
- ↑ 3.0 3.1 FDA approves removal of boxed warning from REGRANEX<TM> (becaplermin) gel, 0.01% as multiple studies demonstrate product safety. http://www.smith-nephew.com/news-and-media/media-releases/news/fda-approves-removal-of-boxed-warning-from-regranex-becaplermin-gel-001-as-multiple-studies-demonstrate-product-safety/