A front-line solution to a serious problem

The five-year mortality rate for patients with diabetic ulcers is greater than many cancers.1-3 REGRANEX Gel helps treat lower extremity diabetic ulcers with faster healing rates than standard care alone.4

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How much is enough?

Use this dosing calculator to determine how much REGRANEX Gel is enough based on your patient's wound size.

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At home. Once a day. Three steps.

Patients and/or their caregivers can apply REGRANEX Gel in the comfort of home.

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Support for prescribers and patients

The Regranex360 comprehensive program helps with benefits, compliance, coverage, and more.

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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 (becaplermin) Gel, 0.01% 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 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.

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 (eg, 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 and 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.

Show References

  1. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26:491-494.
  2. Armstrong DG, Wrobel J, Robbins JM. Guest editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4:286-287.
  3. American Cancer Society. Cancer Facts & Figures 2014. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2014/cancer-facts-and-figures-2014.pdf. Accessed May 5, 2017.
  4. Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21:822-827.
  5. REGRANEX Gel Prescribing Information.
  6. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
  7. Diegelmann RF, Evans MC. Wound healing: an overview of acute, fibrotic and delayed healing. Front Biosci. 2004;9:283-289.
  8. Guo S, DiPietro LA. Factors affecting wound healing. J Dent Res. 2010;89:219-229.
  9. 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.
  10. Edmonds M, Foster AV, 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.
  11. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14:680-692.
  12. 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(4 Suppl):S1-S24.
  13. Papanas N, Maltezos E. Benefit-risk assessment of becaplermin in the treatment of diabetic foot ulcers. Drug Saf. 2010;33:455-461.
  14. 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.
  15. Delamater AM. Improving patient adherence. Clin Diabetes. 2006;24:71-77.
  16. Lantis JC II, Boone D, Gendics C, Todd G. Analysis of patient cost for recombinant human platelet-derived growth factor therapy as the first-line treatment of the insured patient with a diabetic foot ulcer. Adv Skin Wound Care. 2009;22:167-171.
  17. Data on file. Smith & Nephew. October 2012.
  18. Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot and Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45(5 Suppl):S1-S66.
  19. Huang ES, Basu A, O’Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the US. Diabetes Care. 2009;32:2225-2229.
  20. Boulton AJ. The diabetic foot: grand overview, epidemiology and pathogenesis. Diabetes Metab Res Rev. 2008;24 Suppl 1:S3-S6.
  21. International Working Group on the Diabetic Foot. Time to act. Available at: https://www.worlddiabetesfoundation.org/sites/default/files/Diabetes%20and%20Foot%20care_Time%20to%20act.pdf. Accessed May 9, 2017.
  22. Adeshara KA, Diwan AG, Tupe RS. Diabetes and complications: cellular signalling pathways, current understanding and targeted therapies. Curr Drug Targets. 2016;17:1309-1328.
  23. Kirsner RS. The standard of care for evaluation and treatment of diabetic foot ulcers. The University of Michigan Medical School. The University of Michigan Health System’s Educational Services for Nursing. Barry University School of Podiatric Medicine 2010. Available at: http://www.barry.edu/includes/docs/continuing-medical-education/diabetic.pdf. Accessed May 5, 2017.

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 (becaplermin) Gel, 0.01% 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.

Important Safety Information

People who use 3 or more tubes of REGRANEX (becaplermin) Gel may have an increased risk of death from cancer.

You should talk with your healthcare provider about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX Gel. If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX Gel.