Important Safety Information
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.
- The efficacy of REGRANEX gel has not been established for the treatment of pressure ulcers and venous stasis ulcers.
- The effects of REGRANEX gel on exposed joints, tendons, ligaments, and bone have not been 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.
Malignancies distant from the site of application have been reported in both a clinical study and in posmarketing use. The benefits and risks of REGRANEX gel treatment should be carefully evaluated before prescribing in patients with known malignancy.
See complete prescribing information for more details.
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- REGRANEX gel Prescribing Information.
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