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, 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 stasis ulcers (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. Important Safety Information: REGRANEX Gel is contraindicated in patients with neoplasms at the site of application. An increased risk of mortality secondary to malignancy remote from the site of treatment has been observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. (See Boxed WARNING). However, in a separate analysis of cancer incidence, these results were consistent with no overall increase in cancer incidence (See WARNINGS). REGRANEX Gel should be used with caution in patients with known malignancy. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of this product (eg, parabens). Erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo gel. REGRANEX Gel should not be used in wounds that close by primary intention. Click here for Full Prescribing Information for REGRANEX Gel. |