REGRANEX (becaplermin) gel
[SMITH & NEPHEW, INC.]
These highlights do not include all the information needed to use REGRANEX
® Gel safely and effectively. See full prescribing information for REGRANEX Gel.
REGRANEX
® (becaplermin) GEL for TOPICAL use.
Initial U.S. Approval: 1997
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. (5.1)
INDICATIONS AND USAGE
REGRANEX Gel contains becaplermin, a human platelet-derived growth factor that 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. (1.1)
Limitations of use:
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The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers. (1.2)
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The effects of REGRANEX Gel on exposed joints, tendons, ligaments, and bone have not been established in humans. (1.2)
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REGRANEX Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention. (1.2)
DOSAGE AND ADMINISTRATION
For topical use; not for oral, ophthalmic or intravaginal use. (2)
To calculate the length of REGRANEX Gel to apply, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. (2)
Formula to Calculate Length of Gel to Be Applied Daily
|
|
Inches or Centimeters |
|
Tube Size |
Formula |
|
15g tube |
Inches: ulcer length × ulcer width × 0.6 |
|
15g tube |
Centimeters: ulcer length × ulcer width ÷ 4 |
DOSAGE FORMS AND STRENGTHS
Gel: 0.01% (3)
CONTRAINDICATIONS
Known neoplasm(s) at the site(s) of application (4)
WARNINGS AND PRECAUTIONS
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. (5.1)
ADVERSE REACTIONS
Erythematous rashes occurred in 2% of patients treated with REGRANEX Gel (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Smith & Nephew, Inc. at 1-800-441-8227.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2014
