REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous statis ulvers (see CLINICAL STUDIES) and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.

The amount of REGRANEX Gel to be applied will vary depending upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 2, and to calculate the length of gel in centimeters, use the formula shown below in Table 3.

Table 2: Formula to Calculate Length of Gel in Inches to be Applied Daily

Using the calculation, each square inch of ulcer surface will require approximately 2+3 inch length of gel squeezed from a 15g tube, or approximately 1 1/3inch length of the gel from a 2g tube. For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for a 15g tube (1 X 2 X 0.6=1 1/4)and 2 3/4 inch gel length should be used for a 2g tube (1 X 2 X 1.3=2 3/4).

Table 3: Formula to Calculate Length of Gel in Centimeters to be Applied Daily

Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15g tube, or approximately a 0.5 centimeter length of gel from a 2g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 centimeter length of gel should be used for a 15g tube [(4 X 2) divided by 4=2] and a 4 centimeter length of gel should be used for a 2g tube [(4 X 2) divided by 2=4].

The amount of REGRANEX Gel to be applied should be recalculated by the physician or wound care giver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX Gel from a 15g tube is 0.65g per inch length and 0.25g per centimeter length.

To apply REGRANEX Gel, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper. The measured REGRANEX Gel is transferred from the clean measuring surface using an application aid and then spread over the entire ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a second moist dressing (without REGRANEX Gel) for the remainder of the day. REGRANEX Gel should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX Gel should be reassessed. The step-by-step instructions for applying REGRANEX Gel for home administration are described under "Information for Patients".

REGRANEX (becaplermin) Gel, supplied as a clear, colorless to straw-colored preserved gel containing 100µg of becaplermin per gram of gel, is available in multi-use tubes in the following sizes:

REGRANEX Gel is for external use only.

Storage
Store refrigerated, 2-8º C (36-46º F). DO NOT FREEZE. DO NOT USE THE GEL AFTER THE EXPIRATION DATE AT THE BOTTOM OF THE TUBE.

Caution: Federal (USA) law prohibits dispensing without prescription.

Distributed by: OMP DIVISION, ORTHO-McNEIL PHARMACEUTICAL, INC., Raritan, New Jersey 08869
Manufactured by: OMJ Pharmaceuticals, Inc., U.S. License No. 1196, San German, Puerto Rico 00683
Bacaplermin Concentrate provided by: Chiron Corp., U.S. License No. 1106, Emeryville, CA 94608
FDA Revision: 05/18/2005

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