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Drug overview for REGRANEX (becaplermin):
Generic name: BECAPLERMIN (be-KAP-ler-min)
Drug class: Wound Healing, Topical Growth Factor
Therapeutic class: Dermatological
Becaplermin is a recombinant, human platelet-derived growth factor.
No enhanced Uses information available for this drug.
Generic name: BECAPLERMIN (be-KAP-ler-min)
Drug class: Wound Healing, Topical Growth Factor
Therapeutic class: Dermatological
Becaplermin is a recombinant, human platelet-derived growth factor.
No enhanced Uses information available for this drug.
DRUG IMAGES
REGRANEX 0.01% GEL
The following indications for REGRANEX (becaplermin) have been approved by the FDA:
Indications:
Diabetic neuropathic ulcer of lower extremity
Professional Synonyms:
Diabetic neuropathic ulcer of leg or foot
Diabetic neuropathic ulcer of the lower extremity
Indications:
Diabetic neuropathic ulcer of lower extremity
Professional Synonyms:
Diabetic neuropathic ulcer of leg or foot
Diabetic neuropathic ulcer of the lower extremity
The following dosing information is available for 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.
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| REGRANEX 0.01% GEL | Maintenance | Adults apply the calculated amount of gel to the affected area(s) by topical route once daily |
No generic dosing information available.
The following drug interaction information is available for REGRANEX (becaplermin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for REGRANEX (becaplermin):
Drug contraindication overview.
Known neoplasms at the site(s) of becaplermin gel application. (See Risk of Cancer under Cautions: Warnings/Precautions.)
Known neoplasms at the site(s) of becaplermin gel application. (See Risk of Cancer under Cautions: Warnings/Precautions.)
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Malignancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for REGRANEX (becaplermin):
Adverse reaction overview.
Erythematous rashes occurred in approximately 2% of patients who received becaplermin gel (with good ulcer care) during clinical trials.
Erythematous rashes occurred in approximately 2% of patients who received becaplermin gel (with good ulcer care) during clinical trials.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Malignancy |
There are 4 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Erythema Skin rash Stinging of skin Treatment site sequelae |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for REGRANEX (becaplermin):
Safety and efficacy of becaplermin gel have not been established in patients younger than 16 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
The following prioritized warning is available for REGRANEX (becaplermin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for REGRANEX (becaplermin)'s list of indications:
| Diabetic neuropathic ulcer of lower extremity | |
| E08.621 | Diabetes mellitus due to underlying condition with foot ulcer |
| E09.621 | Drug or chemical induced diabetes mellitus with foot ulcer |
| E10.621 | Type 1 diabetes mellitus with foot ulcer |
| E11.621 | Type 2 diabetes mellitus with foot ulcer |
| E13.621 | Other specified diabetes mellitus with foot ulcer |
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