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becaplermin (Regranex)
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:
1) systemically available PDGF < 3%
2) rash (2%)
* Boxed warning:
- 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.
General
platelet-derived growth factor subunit B; PDGF subunit B; PDGF-2; platelet-derived growth factor B chain; platelet-derived growth factor beta polypeptide; proto-oncogene c-sis; Becaplermin (PDGFB, PDGF2, SIS)
recombinant protein; chimer
dermatologic agent
References
- Ortho-McNeil Pharmaceuticals
- FDA MedWatch
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex
- FDA approves removal of boxed warning from REGRANEX
(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/