Medication Guide App

Becaplermin

Pronunciation: be-KAP-ler-min
Class: Wound healing agent

Trade Names

Regranex
- Topical gel 0.01%

Pharmacology

Promotes the chemotactic recruitment and proliferation of cells involved in wound repair and enhances the formation of granulation tissue.

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Pharmacokinetics

Absorption

Systemic bioavailability was nonquantifiable in clinical studies.

Indications and Usage

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

Contraindications

Known hypersensitivity to any component of the product; known neoplasm at the site(s) of application.

Dosage and Administration

Adults and Adolescents 16 yr of age and older

Topical Amount applied varies depending upon the size of the ulcer. Each square inch of ulcer requires approximately 2/ 3 - or 1 1/ 3 –inch length of gel from a 15 or 2 g tube, respectively, applied daily.

General Advice

  • The amount of becaplermin gel to be applied depends on the rate of change of the ulcer area, and should be recalculated at weekly or biweekly intervals by the health care provider or caregiver.
  • Apply by squeezing the required length of gel onto a clean measuring surface (eg, wax paper). Then transfer the gel, using an application aid, and spread the gel over the entire ulcer area, in a thin continuous layer approximately 1/ 16 of an inch thick.
  • After application, cover the site with a saline moistened dressing and leave in place for approximately 12 h.
  • Remove the dressing and rinse the ulcer with saline or water to remove residual gel and cover again with a second moist dressing for the remainder of the day.
  • Apply once daily until ulcer completely heals.
  • If the ulcer does not decrease in size by 30% after 10 weeks or completely heal within 20 weeks, continued treatment should be reassessed.

Storage/Stability

Store in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Erythematous rash (2%).

Precautions

Warnings

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin gel. Use with caution in patients with known malignancy.


Monitor

Monitor for evidence of reduced ulcer.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 16 yr of age.

Elderly

No differences in safety and efficacy were observed in patients 65 yr of age and older compared with younger patients.

Malignancy

Use with caution in patients with known malignancy.

Sensitization

If application-site reactions occur, consider the possibility of paraben or m-cresol sensitization or irritation.

Overdosage

Symptoms

No information available.

Patient Information

  • Instruct patients to thoroughly wash hands prior to applying the gel.
  • Instruct patient not to allow the tip of the tube to come into contact with the ulcer or any other surface.
  • Instruct patient to apply gel with a cotton swab, tongue depressor, or other application aid.

Copyright © 2009 Wolters Kluwer Health.

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