Becaplermin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Regranex: 0.01% (15 g) [contains metacresol, methylparaben, propylparaben]

Pharmacology

Mechanism of Action

Recombinant B-isoform homodimer of human platelet-derived growth factor (rPDGF-BB) which enhances formation of new granulation tissue, induces fibroblast proliferation and differentiation to promote wound healing; also promotes angiogenesis.

Use: Labeled Indications

Diabetic ulcers: Adjunctive treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

Limitations of use: Efficacy has not been established for pressure and venous stasis ulcers; has not been evaluated for 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.

Contraindications

Known neoplasm(s) at the site(s) of application

Dosage and Administration

Dosing: Adult

Diabetic ulcers (lower extremity): Topical: Apply appropriate amount of gel once daily with a cotton swab, tongue depressor, or similar tool, as a coating over the ulcer. The amount of becaplermin to be applied will vary depending on the size of the ulcer area.

Note: If the ulcer does not decrease in size by ~30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with becaplermin gel should be reassessed.

Estimation of gel requirement: To calculate the length of gel applied to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer. Recalculate amount of gel needed every 1 to 2 weeks, depending on the rate of change in ulcer area.

Centimeters: 15 g tube: [ulcer length (cm) x width (cm)] divided by 4 = length of gel (cm)

Inches: 15 g tube: [length (in) x width (in)] x 0.6 = length of gel (in)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Diabetic ulcers (lower extremity): Adolescents ≥16 years: Refer to adult dosing.

Administration

For topical use; not for oral, ophthalmic, or intravaginal use. Squeeze appropriate amount of gel onto clean measuring surface (eg, wax paper), spread onto entire ulcer area in a thin, continuous layer ~¹/₁₆ inch thick. Cover with saline moistened dressing; leave dressing in place ~12 hours. After 12 hours, remove dressing, rinse with saline or water to remove residual becaplermin gel and cover with saline moistened dressing (without becaplermin gel) for remainder of the day. Continue use once daily until ulcer is completely healed.

Storage

Refrigerate at 2°C to 8°C (36°F to 46°F); do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%: Dermatologic: Erythematous rash (2%)

<1%, postmarketing, and/or case reports: Connective tissue disorder (excessive granulation tissue), dermal ulcer (with or without tunneling), erythema (with purulent discharge), local pain

Warnings/Precautions

Concerns related to adverse effects:

• Application site reactions: Sensitization or irritation of skin may occur; may be due to parabens or m-cresol. Interruption or discontinuation of treatment should be considered; further evaluation (eg, patch testing) may be necessary.
• Malignancy: Malignancies of varying types have been reported; all were remote from the becaplermin treatment site. Use with caution in patients with known malignancy. Becaplermin should only be used when the benefits can be expected to outweigh the risks.

Other warnings/precautions:

• Appropriate use: For external use only; do not use in wounds that close by primary intention. Effects on exposed joints, tendons, ligaments and bone have not been established.

Monitoring Parameters

Ulcer volume (pressure ulcers); wound area; evidence of closure; drainage (diabetic ulcers); signs/symptoms of toxicity (erythema, local infections)

Pregnancy

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Patient Education

What is this drug used for?

• It is used to treat skin ulcers.

Frequently reported side effects of this drug

• Redness

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Application site irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.