Dosing and uses of Regranex Gel (becaplermin)
Adult dosage forms and strengths
geL
- 0.01%
Diabetic Neuropathic Ulcers
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)
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 hours; then rinse off residual gel with saline & apply new saline-moistened dressing (no gel)
Re-measure ulcer weekly or bi-weekly to adjust dosage
If ulcer size not decreased 30% in 10 weeks, or not healed in 20 weeks, reassess continued treatment with becaplermin
Pediatric dosage forms and strengths
<16 years old: Safety & efficacy not established
Regranex Gel (becaplermin) adverse (side) effects
1-10%
Erythema
Skin rash
<1%
Ulcer infection
Tunneling of ulcer
Skin ulceration
Local pain
Warnings
Black box warnings
An increased risk of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin gel in a postmarketing retrospective cohort study. It should only be used when the benefits can be expected to outweigh the risks. This drug should be used with caution in patients with known malignancy.
Contraindications
Hypersensitivity
Neoplasm at application site
Cautions
Malignancy
Increased risk of cancers if exposed to 3 or more tubes
Do not use on self-healing wounds
Store in fridge; do NOT freeze
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
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 of Regranex Gel (becaplermin)
Mechanism of action
Recombinant human PDGF-BB; stimulates chemotactic recruitment of wound-healing cells; promotes angiogenesis and induces fibroblast proliferation and differentiation to promote wound healing; granulation tissue enhancer
Pharmacokinetics
Onset of action: Within 8 weeks (15% completely healed); within 10 weeks (25% completely healed)
Distribution: Binds to normal skin and granulation tissue
