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Becaplermin

Pronunciation

(be KAP ler min)

Index Terms

  • Recombinant Human Platelet-Derived Growth Factor B
  • rPDGF-BB

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]

Brand Names: U.S.

  • Regranex

Pharmacologic Category

  • Growth Factor, Platelet-Derived
  • Topical Skin Product

Pharmacology

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

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. Tube size and unit of measure will determine the formula used in the calculation. 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)

2 g tube: [ulcer length (cm) x width (cm)] divided by 2 = length of gel (cm)

Inches:

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

2 g tube: [length (in) x width (in)] x 1.3 = length of gel (in)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

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. The following stability information has also been reported: May be stored at room temperature for up to 6 days (Cohen, 2007).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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

<1% (Limited to important or life-threatening): Dermal ulcer (with or without tunneling), erythema (with purulent discharge), excessive granulation tissue, infected skin ulcer, local pain

ALERT: U.S. Boxed Warning

Malignancy:

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin in a postmarketing retrospective cohort study. Becaplermin should only be used when the benefits can be expected to outweigh the risks. Becaplermin should be used with caution in patients with known malignancy.

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: [U.S. Boxed Warning]: An increased rate of mortality secondary to malignancies was observed in a postmarketing retrospective cohort study of patients treated with ≥3 tubes of becaplermin. Becaplermin should only be used when the benefits can be expected to outweigh the risks. Use with caution in patients with known malignancy. Malignancies of varying types have been reported; all were remote from the becaplermin treatment site.

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 Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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