Indication

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.

• Limitations of use:
  • The efficacy of REGRANEX® Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (State I or II, IAET staging classification) or ischemic diabetic ulcers.
  • The effects of REGRANEX® Gel on exposed joints, tendons, ligaments, and bone have not established in humans.
  • REGRANEX® Gel is a non-sterile, low bioburden preserved product. Therefore it should not be used in wounds that close by primary intention.

Important Safety Information (continued below)

• An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX® Gel in a postmarketing retrospective cohort study. --continued--(See Important Safety Information, including BOXED WARNING, below).
• REGRANEX® Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.
• Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. REGRANEX® Gel should be used with caution in patients with a known malignancy.
• In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX® Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone.

Efficacy

Clinical studies have shown that when used as an adjunct to and not a substitute for good wound care practice (including sharp debridement or removal of dead tissue), REGRANEX® Gel increases the incidence of complete healing of diabetic foot ulcers over time.

Conventional treatment for diabetic foot ulcers involves keeping the wound clean and moist, using saline solution, and bandages. However, some wounds may take a long time to heal or not heal at all. REGRANEX Gel contains a genetically engineered growth factor (referred to as platelet-derived growth factor) normally found in the body that promotes the chemotactic recruitment and proliferation of cells involved in wound repair and enhances the formation of granulation tissue..

There have been over one million prescriptions written for REGRANEX Gel since it was introduced in 1998 (IMS DATA, 1998-2005).

REGRANEX Gel is covered under many prescription drug plans.

Dosage

REGRANEX® Gel should be applied once a day, directly to the wound, and then covered with a moist dressing. Rinse the wound with saline or water and cover it approximately 12 hours, the dressing should be removed and the ulcer rinsed with saline or water to remove residual gel. The wound should then be covered again with a moist dressing.

The amount of REGRANEX® Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals using the formulas found in the Prescribing Information.

If the ulcer is not approximately 30% smaller after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX® Gel should be reassessed.

REGRANEX® Gel is supplied in 15-gram tubes containing becaplermin. It is for topical external use only (not for oral, ophthalmic or intravaginal use) and must be kept refrigerated (2 - 8°C, 36° - 46° F) at all times. Do not freeze.

Click here to view the full U.S. Prescribing Information including Boxed Warning & Medication Guide.

For more information, contact:

REGRANEX Gel Clinical Communication Center

1-888-REGRANEX (1-888-734-7263)