Becaplermin (Monograph)

Brand name: Regranex
Drug class: Cell Stimulants and Proliferants
Chemical name: Recombinant human platelet-derived growth factor B
CAS number: 165101-51-9

Medically reviewed by Drugs.com on Jul 12, 2023. Written by ASHP.

Introduction

Recombinant human platelet-derived growth factor (PDGF).

Uses for Becaplermin

Lower Extremity Diabetic Ulcers

Used topically as an adjunct to good ulcer care (e.g., adequate offloading, debridement, infection control, use of dressings that support moist wound healing) for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

Topical application of becaplermin gel in conjunction with good ulcer care reduces time to achieve complete ulcer healing and is associated with a higher incidence of complete ulcer closure.

Some experts suggest that due to lack of long-term data on the potential risk of malignancy (see Risk of Cancer under Cautions), becaplermin therapy should be reserved for treatment of diabetic foot ulcers that have not responded to standard ulcer care; some clinicians do not recommend routine use of becaplermin gel.

Efficacy of becaplermin gel not established for treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (International Association of Enterostomal Therapy [IAET] classification stage I or II), pressure ulcers, or venous stasis ulcers.

Nonsterile, low bioburden preserved product; do not use in wounds that close by primary intention.

Becaplermin Dosage and Administration

Administration

Topical Administration

Apply topically as a 0.01% gel.

For external use only. Do not administer orally, vaginally, or ophthalmically.

Measure appropriate amount of becaplermin gel onto a clean, firm, nonabsorbable surface (e.g., wax paper); transfer to the ulcer using an application aid (e.g., cotton swab, tongue depressor). Apply gel evenly as a thin continuous layer (approximately 1/16 of an inch thick) across the entire ulcer.

Cover application site(s) with a saline-moistened dressing; keep dressing in place for approximately 12 hours. Remove dressing after 12 hours and rinse ulcer with saline or water to remove residual becaplermin gel. After gel has been removed, cover the ulcer again with a saline-moistened dressing (without becaplermin gel) for the remainder of the day.

Dosage

Pediatric Patients

Lower Extremity Diabetic Ulcers

Topical

Patients ≥16 years of age: Dosage recommendations are the same as adults. (See Adults under Dosage and Administration.)

Adults

Lower Extremity Diabetic Ulcers

Topical

Amount of becaplermin gel used will vary depending upon the size of the ulcer.

Apply appropriate amount of becaplermin gel to the ulcer(s) once daily until complete healing has occurred. If the size of the ulcer does not decrease by approximately 30% after 10 weeks of treatment or if complete healing has not occurred after 20 weeks of treatment, reassess continued use of becaplermin gel.

Calculate amount of gel to be applied by measuring the greatest length and width of the ulcer (in inches or centimeters). In the event of multiple wounds, assess each ulcer individually. Excess application of becaplermin gel has not been shown to be beneficial. Use the following equations to calculate the becaplermin gel dose:

Length of gel to be applied (using 15-g tube) in inches or centimeters:

Dose of becaplermin (inches) = length of ulcer (inches) × width of ulcer (inches) × 0.6

Dose of becaplermin (cm) = (length of ulcer [cm] × width of ulcer [cm]) ÷ 4

The clinician or wound caregiver should recalculate the amount of becaplermin gel to be applied at weekly or biweekly intervals depending on the rate of change in the ulcer area.

Cautions for Becaplermin

Contraindications

• Known neoplasms at the site(s) of becaplermin gel application. (See Risk of Cancer under Cautions.)

Warnings/Precautions

Risk of Cancer

Becaplermin is a recombinant human platelet-derived growth factor that promotes cellular proliferation and angiogenesis; malignancies distant from the site of application have occurred with the use of becaplermin gel. An increased incidence of cancer (or cancer mortality with repeated use of the drug) has been reported in patients receiving becaplermin therapy in some postmarketing observational studies but not in others; diabetes mellitus itself may be associated with an increased prevalence of certain cancers.

The manufacturer states that application of becaplermin gel to an area of the body with a known neoplasm is contraindicated. Carefully evaluate risks and benefits of becaplermin therapy before using the drug in patients with known malignancy.

Sensitivity Reactions

Application Site Reactions

Consider possibility of sensitization or irritation caused by parabens or m-cresol if application site reactions occur. Interrupt or discontinue becaplermin therapy and consider further evaluation (e.g., patch testing) as clinically appropriate.

Specific Populations

Pregnancy

Category C.

No available data on use of becaplermin gel in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. If considering use during pregnancy, weigh potential benefits of drug against possible risks to the fetus.

Lactation

Not known whether distributed into human milk. Use with caution in nursing women.

Pediatric Use

Safety and efficacy of becaplermin gel not established in patients <16 years of age.

Geriatric Use

No overall differences in safety or efficacy observed in patients ≥65 years of age compared with younger patients. Insufficient experience in patients ≥75 years of age to determine whether they respond differently than younger adults.

Common Adverse Effects

Erythematous rashes.

Drug Interactions

Data lacking on the use of becaplermin gel with other topical drugs. Not known if becaplermin gel interacts with other topical drugs applied to the ulcer site.

Becaplermin Pharmacokinetics

Absorption

Bioavailability

Negligible systemic absorption. Following administration of becaplermin 0.01% gel at a dosage of 0.32–2.95 mcg/kg (7 mcg/cm²) once daily for 14 days in 10 patients with stage III or IV lower extremity diabetic ulcers, 6 patients had nonquantifiable PDGF concentrations at baseline and during becaplermin therapy, 2 patients had PDGF concentrations that did not increase substantially from baseline with becaplermin therapy, and 2 patients had PDGF concentrations that increased from baseline sporadically during therapy.

Distribution

Extent

Not known whether distributed into human milk.

Stability

Storage

Topical

Gel

2–8°C; do not freeze.

Tube of becaplermin gel may be exposed to room temperature for short periods of time (≤20 minutes) repeatedly until the expiration date of the product without compromising the stability of the drug.

If a tube of the gel is inadvertently exposed to room temperature for a period of time >20 minutes (up to 6 days), place tube of drug back into the refrigerator as soon as possible within that time period. After such exposure, drug may still be used until the expiration date on the tube; however, do not expose a tube of becaplermin gel to room temperature for long periods of time (>20 minutes) more than once for the life of the product.

Actions

• Recombinant human PDGF.

• Becaplermin has biologic activity similar to that of endogenous PDGF-BB. PDGF promotes wound healing by stimulating fibroblast proliferation to increase growth of granulation tissue, increasing the rate of re-epithelialization and revascularization, and promoting collagen production.

Advice to Patients

• Importance of advising patients to read the manufacturer's medication guide.

• Advise patients to review and discuss any questions or concerns with their clinician before receiving becaplermin gel and at regular intervals during therapy.

• Importance of advising patients that becaplermin gel should be used only as directed by a clinician.

• Advise patients to wash hands thoroughly before applying becaplermin gel. Advise patients that the tip of the becaplermin gel tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use.

• Importance of instructing patients about the topical application and storage of becaplermin gel. (See Administration under Dosage and Administration and also see Storage under Stability.)

• Importance of using becaplermin gel in conjunction with a good ulcer care program, including a strict non-weight-bearing program.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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.

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