Becaplermin
Class: Cell Stimulants and Proliferants
Chemical Name: Recombinant human platelet-derived growth factor B
CAS Number: 165101-51-9
Brands: Regranex
Introduction
Recombinant human platelet-derived growth factor (PDGF).
Uses for Becaplermin
Lower Extremity Diabetic Ulcers
Used topically as an adjunct to good ulcer care (e.g., adequate offloading, debridement, infection control, use of dressings that support moist wound healing) for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
Topical application of becaplermin gel in conjunction with good ulcer care reduces time to achieve complete ulcer healing and is associated with a higher incidence of complete ulcer closure.
Some experts suggest that due to lack of long-term data on the potential risk of malignancy (see Risk of Cancer under Cautions), becaplermin therapy should be reserved for treatment of diabetic foot ulcers that have not responded to standard ulcer care; some clinicians do not recommend routine use of becaplermin gel.
Efficacy of becaplermin gel not established for treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (International Association of Enterostomal Therapy [IAET] classification stage I or II), pressure ulcers, or venous stasis ulcers.
Nonsterile, low bioburden preserved product; do not use in wounds that close by primary intention.
Becaplermin Dosage and Administration
Administration
Topical Administration
Apply topically as a 0.01% gel.
For external use only. Do not administer orally, vaginally, or ophthalmically.
Measure appropriate amount of becaplermin gel onto a clean, firm, nonabsorbable surface (e.g., wax paper); transfer to the ulcer using an application aid (e.g., cotton swab, tongue depressor). Apply gel evenly as a thin continuous layer (approximately 1/16 of an inch thick) across the entire ulcer.
Cover application site(s) with a saline-moistened dressing; keep dressing in place for approximately 12 hours. Remove dressing after 12 hours and rinse ulcer with saline or water to remove residual becaplermin gel. After gel has been removed, cover the ulcer again with a saline-moistened dressing (without becaplermin gel) for the remainder of the day.
Dosage
Pediatric Patients
Lower Extremity Diabetic Ulcers
Topical
Patients ≥16 years of age: Dosage recommendations are the same as adults. (See Adults under Dosage and Administration.)
Adults
Lower Extremity Diabetic Ulcers
Topical
Amount of becaplermin gel used will vary depending upon the size of the ulcer.
Apply appropriate amount of becaplermin gel to the ulcer(s) once daily until complete healing has occurred. If the size of the ulcer does not decrease by approximately 30% after 10 weeks of treatment or if complete healing has not occurred after 20 weeks of treatment, reassess continued use of becaplermin gel.
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