Regranex (becaplermin)

For the topical treatment of lower extremity diabetic neuropathic ulcers, the amount of becaplermin gel used will vary depending upon the size of the ulcer. The appropriate amount of becaplermin gel should be applied 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, continued use of becaplermin gel should be reassessed.

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

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

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

Becaplermin is applied topically to the skin as a gel containing 0.01% becaplermin. Becaplermin gel is for external use only and should not be administered orally, vaginally, or ophthalmically.

The appropriate amount of becaplermin gel should be measured on a clean, firm, nonabsorbable surface (e.g., wax paper) and then transferred to the ulcer using an application aid (e.g., cotton swab, tongue depressor). The gel should be applied evenly as a thin continuous layer (approximately 1/16 of an inch thick) across the entire ulcer. The application site(s) should then be covered by a saline-moistened dressing that should remain in place for approximately 12 hours. After 12 hours, the dressing should be removed and the ulcer should be rinsed with saline or water to remove residual becaplermin gel. After removal of the gel, the ulcer should again be covered with a saline-moistened dressing (without becaplermin gel) for the remainder of the day.

Becaplermin gel should be stored at 2-8degreesC until the expiration date on the tube; the gel should not be frozen. The manufacturer states that the tube of becaplermin gel may be exposed to room temperature for short periods of time (i.e., 20 minutes or less) repeatedly until the expiration date of the product without compromising the stability of the drug. If a tube of becaplermin gel is inadvertently exposed to room temperature for a period of time exceeding 20 minutes (i.e., up to 6 days), the tube of gel should be placed back into the refrigerator as soon as possible within that time period. After such exposure, the drug may still be used until the expiration date on the tube; however, the manufacturer states that a tube of becaplermin gel should not be exposed to room temperature for long periods of time (exceeding 20 minutes) more than once for the life of the product.

No dosing information is available for this tab.

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

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known neoplasms at the site(s) of becaplermin gel application. (See Risk of Cancer under Cautions: Warnings/Precautions.)

There are no contraindication contraindications for this drug.

• Malignancy

There are no moderate contraindications for this drug.

Erythematous rashes occurred in approximately 2% of patients who received becaplermin gel (with good ulcer care) during clinical trials.

Rare or Very Rare

• Malignancy

Less Frequent

• Erythema
• Skin rash
• Stinging of skin
• Treatment site sequelae

No enhanced messaging available.

Safety and efficacy of becaplermin gel have not been established in patients younger than 16 years of age.

Category C. (See Users Guide.)

There are no available data on the 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 use during pregnancy is considered, the potential benefits of the drug should be weighed against the possible risks to the fetus.

It is not known whether becaplermin is distributed into human milk. Because many drugs are distributed into human milk, caution is advised if the drug is administered in nursing women.

In clinical trials, no overall differences in safety or efficacy were observed in patients 65 years of age or older compared with younger patients. However, the manufacturer states that clinical studies of becaplermin gel did not include sufficient numbers of patients 75 years of age or older to determine whether they respond differently than younger patients.