REGRANEX (becaplermin) Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

For external use only.

If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered.

The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. In preclinical studies, rats injected at the metatarsals with 3 or 10 µg/site (approximately 60 or 200 µg/kg) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodeling consisting of periosteal hyperplasia and subperiosteal boneresorption and exostosis. The soft tissue adjacent to the injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability of PDGF to stimulate connective tissue growth.

Information for Patients

Patients should be advised that:
- hands should be washed thoroughly before applying REGRANEX Gel;
- 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; - a cotton swab, tongue depressor, or other application aid should be used to apply REGRANEX Gel;
- REGRANEX Gel should only be applied once a day in a carefully measured quantity (see DOSAGE AND ADMINISTRATION section). 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 REGRANEX Gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver;

Step-by-step instructions for application of REGRANEX Gel are as follows:

• Squeeze the calculated length of gel on to a clean, firm, non-absorbable surface,e.g., wax paper.
• With a clean cotton swab, tongue depressor, or similar application and spread the measured REGRANEX Gel over the ulcer surface to obtain an even layer.
• 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 REGRANEX Gel);
- it is important to use REGRANEX Gel together with a good ulcer care program, including a strict non-weight-bearing program;
- excess application of REGRANEX Gel has not been shown to be beneficial;
- REGRANEX Gel should be stored in the refrigerator. Do not freeze REGRANEX Gel;
- REGRANEX Gel should not be used after the expiration date on the bottom, crimped end of the tube.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Becaplermin was not genotoxic in a battery of in vitro assays, (including those for bacterial and mammalian cell point mutation, chromosomal aberration, and DNA damage/repair). Becaplermin was also not mutagenic in an in vivo assay for the induction of micronuclei in mouse bone marrow cells.

Carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX Gel.

Pregnancy: Category C

Animal reproduction studies have not been conducted with REGRANEX Gel. It is also not known whether REGRANEX Gel can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. REGRANEX Gel should be given to pregnant women only if clearly needed.

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 REGRANEX Gel is administered to nursing women.

Geriatric Use

Among the patients receiving any dose of REGRANEX Gel in clinical studies of diabetic lower extremity ulcers, 150 patients were 65 years 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 75 and older were insufficient (n=34) to determine whether they respond differently from younger patients.

Pediatric Use

Safety and effectiveness of REGRANEX Gel in pediatric patients below the age of 16 years have not been established.

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