Dosing & Uses
Dosage Forms & Strengths
topical gel
- 0.01%
Diabetic Neuropathic Ulcers
Indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply; use adjunctively to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief, and infection control
Amount to be applied will vary depending upon size of ulcer area
Formula in inches per tube size
- 15 g tube: Length of ulcer × width × 0.6 = Length of gel (inches)
- 2 g tube: Length of ulcer × width × 1.3 = Length of gel (inches)
Formula in centimeters per tube size
- 15 g tube: Length of ulcer × width ÷ 4 = Length of gel (cm)
- 2 g tube: Length of ulcer × width ÷ 2 = Length of gel (cm)
Dosing Considerations
Efficacy not established for treatment of pressure ulcers and venous stasis ulcers
Efficacy not evaluated for treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification) or ischemic diabetic ulcers
Effects on exposed joints, tendons, ligaments, and bone have not been established in humans
Nonsterile, low bioburden, preserved product; therefore, it should not be used in wounds that close by primary intention
<16 years: Safety and efficacy not established
Adverse Effects
1-10%
Erythema
Skin rash
<1%
Ulcer infection
Tunneling of ulcer
Skin ulceration
Local pain
Postmarketing Reports
Burning sensation at site of application
Warnings
Contraindications
Hypersensitivity
Neoplasm at application site
Cautions
Malignancies distant from the site of application have occurred in patients using becaplermin gel a clinical study and in postmarketing use contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis; evaluate benefits and risks before prescribing in patients with known malignancy
If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered; consider interruption or discontinuation and further evaluation (eg, patch testing) according to clinical circumstances
Pregnancy & Lactation
Pregnancy
No data are available
Animal reproduction studies have not been conducted
Lactation
No data are available; developmental and health benefits of breastfeeding should be considered along with the lactating woman’s clinical need for the drug and any potential adverse effects on the breastfed child from becaplermin
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant human platelet-derived growth factor; promotes chemotactic recruitment and proliferation of cells involved in wound repair and enhances granulation tissue formation
Pharmacokinetics
Onset of action: Within 8 weeks (15% completely healed); within 10 weeks (25% completely healed)
Distribution: Binds to normal skin and granulation tissue
Administration
Topical Administration
Squeeze calculated length of gel onto clean surface, then spread evenly over ulcer using cotton swab, tongue depressor or similar implement
Cover gel with saline-moistened dressing for 12 hr; then rinse off residual gel with saline and apply new saline-moistened dressing (no gel)
Remeasure ulcer weekly or biweekly to adjust dosage
If ulcer size not decreased 30% in 10 weeks, or not healed in 20 weeks, reassess continued treatment with becaplermin
Storage
Refrigerate at 2-8°C (36-46°F
Do not freeze
Images
Patient Handout
Formulary
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