Regranex Logo
For US Healthcare Professionals only.

IMPORTANT SAFETY INFORMATION

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. View More.

GOOD ULCER CARE IS A FOUNDATION FOR HEALING

The healing process for diabetic foot ulcers begins with good ulcer care1

SOMETIMES GOOD ULCER CARE IS NOT ENOUGH

  • Good ulcer care practices alone are often not enough to stop ulcers from becoming chronic5
  • It is estimated that about half (49%) of all diabetic neuropathic foot ulcers treated with good ulcer care alone may still fail to heal6
Good ulcer care, diabetic foot ulcers, debridement, infection control, off-loading, chronic diabetic neuropathic foot ulcers, diabetic neuropathic ulcer, diabetic foot ulcer, diabetic wound

References: 1. Snyder RJ, Hanft JR. Diabetic foot ulcers—effects on quality of life, costs, and mortality and the role of standard wound care and advanced-care therapies in healing: a review. Ostomy Wound Manage. 2009;55:28-38. 2. Edmonds M, Foster AVM, Vowden P. Wound bed preparation for diabetic ulcers. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:6-11. 3. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14:680-692. 4. REGRANEX® Gel Prescribing Information. 5. Snyder RJ, Kirsner RS, Warriner RA III, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010;56(Suppl 4):S1-S24. 6. Papanas N, Maltezos E. Benefit-risk assessment of becaplermin in the treatment of diabetic foot ulcers. Drug Saf. 2010;33:455-461. 7. Falanga V. Wound bed preparation: science applied to practice. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:2-5.

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 use

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. 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.

Contraindications

REGRANEX® 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 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.

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.

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 information

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.

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.

This information is intended for healthcare professionals in the United States and is not intended for the general public.