REGRANEX 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.

The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [

The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans [

REGRANEX is not intended to be used in wounds that close by primary intention.

REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use.

The amount of REGRANEX to be applied depends 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 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2.

Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15 g 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 15 g tubes (1 x 2 x 0.6 = 1 1/4).

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 15 g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 cm length of gel should be used for a 15 g tube [(4 x 2) ÷ 4 = 2].

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

To apply REGRANEX, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper, and measured to the correct length with a ruler. The measured REGRANEX is transferred from the clean measuring surface using an application aid and then spread over the entire cleaned 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 gauze 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 moist primary dressing (without REGRANEX gel) for the remainder of the day. REGRANEX 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 should be reassessed. The step-by-step instructions for applying REGRANEX in a home care setting can be found in the FDA-approved Instructions for Use.

Gel: 0.01%; clear, colorless to straw-colored

REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

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

There are no data on the effects of REGRANEX overdose.

REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast,

Becaplermin has a molecular weight of approximately 25 kD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds. REGRANEX is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate, sodium chloride, and purified water. Each gram of REGRANEX contains 100 mcg of becaplermin.

REGRANEX (0.01%) is clear, colorless to straw-colored and is available in multi-use tubes in the following size:

15 g tube NDC 85822-734-15

Store refrigerated at 2° - 8°C (36° - 46°F). Do not freeze.

Manufactured for and marketed by: LRM, Therapeutics, Inc., Franklin, TN 37067, a wholly owned subsidiary of Lynch Regenerative Medicine, LLC

U.S. Gov’t License # 2443

REGRANEX

Part No. 90038-0526