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Becaplermin: Drug information

Becaplermin: Drug information
(For additional information see "Becaplermin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Regranex
Pharmacologic Category
  • Growth Factor, Platelet-derived;
  • Topical Skin Product
Dosing: Adult
Diabetic ulcers

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: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Diabetic ulcers

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

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

Contraindications

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

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.

Dosage Forms: US

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

Gel, External:

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

Generic Equivalent Available: US

No

Pricing: US

Gel (Regranex External)

0.01% (per gram): $108.78

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

Topical: 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.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf#page=8, must be dispensed with this medication.

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.

Medication Safety Issues
Sound-alike/look-alike issues:

Regranex may be confused with Granulex, Repronex

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if becaplermin is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

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

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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Regranex;
  • (CZ) Czech Republic: Regranex;
  • (DE) Germany: Regranex;
  • (ES) Spain: Regranex;
  • (FR) France: Regranex;
  • (GB) United Kingdom: Regranex;
  • (GR) Greece: Regranex;
  • (HU) Hungary: Regranex;
  • (IE) Ireland: Regranex;
  • (IL) Israel: Regranex;
  • (IN) India: Plermin;
  • (KE) Kenya: Healace;
  • (KR) Korea, Republic of: Regranex;
  • (NL) Netherlands: Regranex;
  • (PR) Puerto Rico: Regranex;
  • (SE) Sweden: Regranex;
  • (SG) Singapore: Regranex;
  • (TW) Taiwan: Regranex;
  • (UG) Uganda: Healace
  1. Regranex (becaplermin) [prescribing information]. Fort Worth, TX: Smith & Nephew, Inc; August 2019.
Topic 8596 Version 136.0

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