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Becaplermin

Class: Cell Stimulants and Proliferants
ATC Class: D03AX06
Molecular Formula: C532H892N162O153S9
CAS Number: 165101-51-9
Brands: Regranex

Warning

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin gel in a postmarketing retrospective cohort study. Becaplermin gel should only be used when the benefits can be expected to outweigh the risks. Becaplermin gel should be used with caution in patients with known malignancy.1

Introduction

Becaplermin is a cell stimulant or proliferant.

Uses for Becaplermin

Becaplermin has the following uses:

Becaplermin gel contains becaplermin, a human platelet-derived growth factor that is indicated for the topical treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. Becaplermin gel is indicated as an adjunct to, and not a substitute for, good ulcer care practices.1

Becaplermin has the following limitations of use:

The efficacy of becaplermin gel has not been established for the treatment of pressure ulcers and venous stasis ulcers.1

The effects of becaplermin gel on exposed joints, tendons, ligaments, and bone have not been established in humans.1

Becaplermin gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.1

Becaplermin Dosage and Administration

General

Becaplermin is available in the following dosage form(s) and strength(s):

Gel: 0.01%1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For topical use; not for oral, ophthalmic or intravaginal use.1

To calculate the length of becaplermin gel to apply, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters.1

Formula to Calculate Length of Gel to Be Applied Daily

Inches or Centimeters

Tube Size

Formula

15g tube

Inches: ulcer length × ulcer width × 0.6

15g tube

Centimeters: ulcer length × ulcer width ÷ 4

Cautions for Becaplermin

Contraindications

Known neoplasm(s) at the site(s) of application.1

Warnings/Precautions

Cancer and Cancer Mortality

Becaplermin gel contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The benefits and risks of becaplermin treatment should be carefully evaluated before prescribing. Becaplermin should be used with caution in patients with a known malignancy.1

Malignancies distant from the site of application have occurred in becaplermin users in both a clinical study and postmarketing use, and an increased rate of death from systemic malignancies was seen in patients who have received 3 or more tubes of becaplermin gel.1

In a follow-up study, 491 (75%) of 651 subjects from two randomized, controlled trials of becaplermin gel 0.01% were followed for a median of approximately 20 months to identify malignancies diagnosed after the end of the trials. Eight of 291 subjects (3%) from the becaplermin group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval 0.6–12.8). The types of cancers varied and all were remote from the treatment site.1

In a retrospective study of a medical claims database, cancer rates and overall cancer mortality were compared between 1,622 patients who used becaplermin gel and 2,809 matched comparators. Estimates of the incidence rates reported below may be under-reported due to limited follow-up for each individual.1

  • The incidence rate for all cancers was 10.2 per 1,000 person years for patients treated with becaplermin gel and 9.1 per 1,000 person years for the comparators. Adjusted for several possible confounders, the rate ratio was 1.2 (95% confidence interval 0.7–1.9). Types of cancers varied and were remote from the site of treatment.1

  • The incidence rate for mortality from all cancers was 1.6 per 1,000 person years for those who received becaplermin gel and 0.9 per 1,000 person years for the comparators. The adjusted rate ratio was 1.8 (95% confidence interval 0.7–4.9).1

  • The incidence rate for mortality from all cancers among patients who received 3 or more tubes of becaplermin gel was 3.9 per 1,000 person years and 0.9 per 1,000 person years in the comparators. The adjusted rate ratio for cancer mortality among those who received 3 or more tubes relative to those who received none was 5.2 (95% confidence interval 1.6–17.6).1

Application Site Reactions

If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (e.g., patch testing) as dictated by clinical circumstances.1

Specific Populations

Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women treated with becaplermin gel. Becaplermin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with becaplermin gel.1

Nursing Mothers

It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when becaplermin gel is administered to nursing women.1

Pediatric Use

Safety and effectiveness of becaplermin gel in pediatric patients below the age of 16 years have not been established.1

Geriatric Use

Among patients receiving any dose of becaplermin gel in clinical studies of diabetic lower extremity ulcers, 150 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients < 65 years of age and patients ≥ 65 years of age. The number of patients aged 75 and older were insufficient (n=34) to determine whether they respond differently from younger patients.1

Common Adverse Effects

Erythematous rashes occurred in 2% of patients treated with becaplermin gel.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

It is not known if becaplermin gel interacts with other topical medications applied to the ulcer site. The use of becaplermin gel with other topical drugs has not been studied.1

Actions

Mechanism of Action

Becaplermin gel has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.1

Advice to Patients

Patient Counseling Information

Counsel patients to review and discuss any questions or concerns with their healthcare provider before starting becaplermin and at regular intervals while receiving becaplermin.1

Patients should be advised that they should read the medication guide. 1

Hands should be washed thoroughly before applying becaplermin gel.1

The tip of the tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use. 1

A cotton swab, tongue depressor, or other application aid should be used to apply becaplermin gel.1

Becaplermin gel should only be applied once a day in a carefully measured quantity. The measured quantity of gel should be spread evenly over the ulcerated area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The measured length of the gel to be squeezed from the tube should be adjusted according to the size of the ulcer. The amount of becaplermin gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver.1

Step-by-Step Instructions for Application of Becaplermin Gel

Squeeze the calculated length of gel onto a clean, firm, nonabsorbable surface (e.g., wax paper).1

With a clean cotton swab, tongue depressor, or similar application aid, spread the measured becaplermin gel over the ulcer surface to obtain an even layer.1

Cover with a saline moistened gauze dressing. After approximately 12 hours, the ulcer should be gently rinsed with saline or water to remove residual gel and covered with a saline-moistened gauze dressing (without becaplermin gel). It is important to use becaplermin gel together with a good ulcer care program, including a strict non-weight-bearing program. Excess application of becaplermin gel has not been shown to be beneficial. Becaplermin gel should be stored in the refrigerator. Do not freeze becaplermin gel. Becaplermin gel should not be used after the expiration date on the bottom, crimped end of the tube.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Becaplermin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

0.01%

Regranex

Smith & Nephew

AHFS Drug Information. © Copyright 2017, Selected Revisions June 5, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Smith & Nephew, Inc. Regranex (becaplermin) topical prescribing information. 2017 Mar.

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