Usage
- Becaplermin is prescribed for the treatment of lower extremity diabetic neuropathic ulcers (foot ulcers) that extend into the subcutaneous tissue or beyond and have adequate blood supply. It is used adjunctively with good ulcer care practices, including initial sharp debridement, pressure relief, and infection control.
- Pharmacological classification: Growth factor.
- Becaplermin is a recombinant human platelet-derived growth factor (rhPDGF-BB). It stimulates cell proliferation and angiogenesis, promoting the formation of granulation tissue and accelerating wound healing.
Alternate Names
- rhPDGF-BB
- Brand Name: Regranex
How It Works
- Pharmacodynamics: Becaplermin binds to PDGF receptors on target cells, such as fibroblasts, smooth muscle cells, and endothelial cells, stimulating their proliferation, migration, and matrix synthesis, leading to granulation tissue formation and wound healing.
- Pharmacokinetics: Topical application of becaplermin gel results in minimal systemic absorption. Studies have shown no consistent increase in plasma PDGF-BB concentrations above pre-treatment levels following multiple topical applications to ulcers.
- Mode of Action: Becaplermin binds to specific cell surface receptors, initiating intracellular signaling cascades that promote cell growth and division, extracellular matrix production, and angiogenesis, thus accelerating wound healing in diabetic neuropathic ulcers.
- Receptor binding: Becaplermin binds to PDGF receptors.
- Elimination pathways: Primarily local degradation with minimal systemic absorption and subsequent renal or hepatic clearance.
Dosage
Standard Dosage
Adults:
- Apply a thin layer of 0.01% becaplermin gel once daily to the entire ulcer area. The amount of gel to be applied is calculated based on the ulcer size (length x width) and varies depending on the tube size (15g or 2g). The dose should be recalculated every 1-2 weeks based on changes in ulcer size. Treatment duration should not exceed 20 weeks. If no significant healing progress is seen after 10 weeks, therapy should be reevaluated.
Children:
- Safety and efficacy have not been established in patients younger than 16 years of age.
Special Cases:
- Elderly Patients: No dose adjustment is generally necessary.
- Patients with Renal Impairment: No dose adjustment is necessary due to minimal systemic absorption.
- Patients with Hepatic Dysfunction: No dose adjustment is necessary due to minimal systemic absorption.
- Patients with Comorbid Conditions: Use with caution in patients with known malignancies. Evaluate risks and benefits carefully.
Clinical Use Cases
Becaplermin is specifically indicated for lower extremity diabetic neuropathic ulcers. It is not indicated for use in other clinical settings such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
- Dose adjustments are based on ulcer size and should be recalculated every 1-2 weeks. No adjustments are necessary based on renal or hepatic function.
Side Effects
Common Side Effects
- Erythema
- Rash
- Burning sensation at the application site
Rare but Serious Side Effects
- Allergic reactions (rash, itching/swelling, dizziness, trouble breathing)
- Increased risk of malignancy (cancer)
Long-Term Effects
- Potential increased risk of cancer with prolonged or repeated use.
Adverse Drug Reactions (ADR)
- Severe allergic reactions requiring immediate medical attention.
Contraindications
- Hypersensitivity to becaplermin or any component of the gel (e.g., parabens).
- Known neoplasm at the site of application.
Drug Interactions
- No formal drug interaction studies have been conducted.
- Concomitant use of other topical medications on the ulcer is not recommended.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C. Not recommended for use during pregnancy.
- Breastfeeding: Excretion in breast milk is unknown. Use with caution in breastfeeding women.
Drug Profile Summary
- Mechanism of Action: Recombinant human PDGF that promotes cellular proliferation and angiogenesis to facilitate wound healing.
- Side Effects: Erythema, rash, burning sensation, increased risk of malignancy.
- Contraindications: Hypersensitivity, neoplasm at application site.
- Drug Interactions: No formal studies, avoid concomitant topical medications.
- Pregnancy & Breastfeeding: Not recommended in pregnancy, use with caution while breastfeeding.
- Dosage: Topical application once daily, dose calculated based on ulcer size, max 20 weeks.
- Monitoring Parameters: Ulcer size, healing progress, signs of infection or adverse reactions.
Popular Combinations
- Becaplermin is typically used in conjunction with good ulcer care practices (debridement, offloading, infection control, moist wound dressings) but not combined with other medications applied directly to the ulcer.
Precautions
- General Precautions: Evaluate for hypersensitivity, malignancy, and infection before starting therapy. Monitor for adverse reactions.
- Specific Populations:
- Pregnant Women: Avoid use.
- Breastfeeding Mothers: Use with caution.
- Children & Elderly: Safety and efficacy not established in children <16 years. No specific precautions for the elderly.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Becaplermin?
A: Apply a thin layer once daily, calculated based on ulcer size, adjusted every 1-2 weeks. Maximum treatment duration is 20 weeks.
Q2: How does Becaplermin work?
A: It’s a recombinant human PDGF that stimulates cell growth and blood vessel formation, promoting wound healing.
Q3: What are the common side effects?
A: Erythema, rash, and burning sensation at the application site.
Q4: Is Becaplermin safe to use during pregnancy?
A: No, it is not recommended for use during pregnancy.
Q5: Can Becaplermin be used with other topical medications?
A: No, concomitant use with other topical medications on the ulcer is not recommended.
Q6: How long can Becaplermin be used?
A: Maximum treatment duration is 20 weeks. Re-evaluate if no significant improvement after 10 weeks.
Q7: What are the contraindications to using Becaplermin?
A: Known hypersensitivity, and the presence of a neoplasm at the application site.
Q8: Are there any special considerations for elderly patients?
A: No specific dose adjustments are necessary for elderly patients.
Q9: What type of ulcer is Becaplermin used for?
A: Lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood supply. It is not effective for pressure ulcers or venous stasis ulcers.
