Drug Guide
Becaplermin
Classification
Therapeutic: Wound Healing Agent
Pharmacological: Recombinant Human Platelet-Derived Growth Factor (rhPDGF)
FDA Approved Indications
- Treatment of diabetic neuropathic foot ulcers that extend into the dermis and have an adequate blood supply
Mechanism of Action
Becaplermin is a recombinant human platelet-derived growth factor-BB (rhPDGF-BB) that stimulates cellular proliferation and angiogenesis, promoting wound healing in diabetic foot ulcers.
Dosage and Administration
Adult: Apply a thin layer of Becaplermin gel (0.4 mg/cm²) to the wound surface, cover with a sterile dressing, and repeat once daily. The maximum dose is generally 20 doses or for 12 weeks, whichever occurs first.
Pediatric: Not established; safety and efficacy not determined.
Geriatric: Use with caution; consider potential for increased sensitivity or adverse effects.
Renal Impairment: No specific adjustments recommended but monitor closely.
Hepatic Impairment: No specific adjustments required.
Pharmacokinetics
Absorption: Minimal systemic absorption when applied topically.
Distribution: Localized at the site of application.
Metabolism: Degraded locally at the application site, no significant systemic metabolism.
Excretion: Excreted through normal tissue turnover; systemic excretion data limited.
Half Life: Not applicable due to localized application.
Contraindications
- Known hypersensitivity to Becaplermin or any component of the formulation.
Precautions
- Use with caution in patients with known malignancy or history of neoplasia; not recommended for use on malignant tumors. Close monitoring for potential tumorigenic effects is advised, especially with multiple or prolonged applications.
Adverse Reactions - Common
- Local skin irritation (Likely)
- Infection at the application site (Uncommon)
Adverse Reactions - Serious
- Tumorigenesis, possibly related to growth factor activity (Rare)
- Allergic reactions, including anaphylaxis (Rare)
Drug-Drug Interactions
- No significant interactions reported.
Drug-Food Interactions
- No specific interactions known.
Drug-Herb Interactions
- No specific interactions known.
Nursing Implications
Assessment: Evaluate wound size, depth, and signs of infection; monitor for adverse effects.
Diagnoses:
- Impaired skin integrity
- Potential for infection
Implementation: Apply as directed; maintain sterile technique; educate patient on wound care.
Evaluation: Determine wound healing progress; monitor for adverse reactions.
Patient/Family Teaching
- Keep the wound clean and dry.
- Avoid applying at the same site with other topical agents.
- Report signs of infection or adverse reactions.
- Attend regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Potential risk of malignancy has not been conclusively established, but caution is advised with long-term or multiple applications.
Genetic Factors: None identified.
Lab Test Interference: None reported.
Overdose Management
Signs/Symptoms: Local tissue overgrowth; possible tumor formation with prolonged use.
Treatment: Discontinue use; provide supportive wound care; monitor for adverse effects.
Storage and Handling
Storage: Store at 2°C to 8°C (35°F to 46°F); do not freeze.
Stability: Stable until expiration date when stored properly.