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IMPORTANT SAFETY INFORMATION
WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY
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. REGRANEX® Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX® Gel should be used with caution in patients with known malignancy.
Indication and limitations of useREGRANEX® (becaplermin) 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. REGRANEX® Gel is indicated 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® 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 (Stage I or II, IAET staging classification) or ischemic diabetic 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.
ContraindicationsREGRANEX® Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application. REGRANEX® Gel is contraindicated in patients with known hypersensitivity to any component of the product (e.g., parabens).
Warnings and precautionsMalignancies 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.
If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered.
Commonly observed adverse reactionsIn 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.
See warnings above regarding malignancy.
Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX® Gel.
Other important informationThe amount of REGRANEX® Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending upon the rate of change in ulcer area.
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.
Pregnancy & Nursing Mothers: Pregnancy Category C. REGRANEX® Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REGRANEX® Gel is administered to nursing women.
Safety and effectiveness of REGRANEX® Gel in pediatric patients below the age of 16 years have not been established.
Counsel patients to review the Medication Guide and to discuss any questions or concerns with their healthcare provider before starting REGRANEX® Gel and at regular intervals during treatment, including when their prescription is refilled.
To report suspected adverse reactions, contact Smith & Nephew at 1-800-441-8227 or contact FDA at www.fda.gov/medwatch or at 1-800-FDA-1088.
Please see accompanying full Prescribing Information and Medication Guide.