Indication and Important Safety Information including Boxed Warning

Indication

• REGRANEX® (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, 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 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. 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. [See Warnings and Precautions (5.1)].

 

• Contraindications—REGRANEX® Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.
• Warnings and Precautions—
  • Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. REGRANEX® Gel shoul 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 reactions—
  • 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.
  • Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX® Gel.
• Use—
  • REGRANEX® Gel is for topical use; not for oral, ophthalmic or intravaginal use.
  • REGRANEX® Gel should not be used by patients sensitive to any of its components.
  • The use of REGRANEX® Gel with other topical drugs has not been studied.
  • The 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.
• Pediatric Patients—Safety and effectiveness of REGRANEX® Gel in pediatric patients below the age of 16 years have not been established.
• Pregnancy & Nursing Mothers—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.

Please see Full Prescribing Information, including Boxed Warning and Medication Guide.

 

To report suspected adverse reactions, contact Healthpoint Biotherapeutics at 1-800-441-8227 or FDA at www.fda.gov/medwatch or at 1-800-FDA-1088.

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