- See Important Safety Information Below
- Full U.S. Prescribing Information including BOXED WARNING & Medication Guide
Regranex Gel REGRANEX GEL diabetic foot ulcers
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REGRANEX® (becaplermin) Gel, 0.01%
Diabetic Foot Ulcer Backgrounder


Diabetic Foot Ulcers: A Serious Problem

Diabetes affects more than 25 million Americans and that number is forecast to increase within the next 5 years, with approximately 1 million new cases diagnosed each year. ¹

One of the many complications of diabetes is foot disease.  Approximately 900,000 diabetic foot ulcers will occur each year, with many of these classified as non-healing. ¹

Additionally, more than 60 percent of non-traumatic lower-limb amputations occur in people with diabetes. In 2006, approximately 180 non-traumatic lower-limb amputations PER DAY were performed in people with diabetes. ²

Other studies have suggested that diabetes-related amputations cost approximately three billion dollars per year ($38,077 per amputation procedure) ³

 

From Blister to Ulceration

Diabetes can cause nerve damage and circulatory problems in the feet. This can result in loss of feeling and make it difficult for those with the disease to feel pain or notice a sore. Diabetes can also lead to a diminished response to infection.

Minor injuries, such as a blister from a poorly fitting shoe, cracks in dry skin, or burns, should not go unnoticed, undiagnosed, or untreated. Otherwise, they can become chronic or nonhealing ulcers.

Good Prevention Goes a Long Way

The first step toward prevention of foot ulcers is controlling diabetes, exercising, avoiding smoking, and maintaining a healthy body weight. It is also important to check feet daily for cuts, sores, or blisters; redness or swelling; infected or blackened toenails; and corns and calluses. Any cut, sore, bruise, or blister that does not begin to heal in two days should be reported to a doctor.

Follow good foot care practices, including washing feet in warm (not hot) water, drying feet well, moisturizing feet with lotion, applying sunscreen, and keeping nails trimmed.

Avoid walking barefoot and always wear well-fitting shoes and socks.

Early Treatment Is Key

Patients with diabetes should call their doctor or healthcare professional immediately if they see any cut, sore, bruise, or blister on their feet that doesn't begin to heal in two days. Treatment may include:

  • Debridement (removing unhealthy tissue around the wound to encourage a supply of healthy blood)
  • Treating infection with antibiotics if necessary
  • Relieving pressure on the wound by recommending orthopedic shoes, inserts, walkers, crutches, or wheelchairs (offloading)
  • Dressing the wound to help keep it clean and moist
  • Prescribing a medication that has been shown in clinical studies to help increase the incidence of complete healing (See important safety information below)

For more information, contact:

REGRANEX Gel Clinical Communication Center

1-888-REGRANEX (1-888-734-7263)

References
1- https://www.smarttrak.net/markets/3020/#all_article_108149
2- http://diabetes.niddk.nih.gov/dm/pubs/statistics/#Amputations
3- Arran Shearer, et al, “Predicted Costs and Outcomes from Reduced Vibration Detection in People with Diabetes in the U.S.,” Diabetes Care 26 (2003): 2305-10; and Adam Gordois, et al, “The Health Care Costs of Diabetic Peripheral Neuropathy in the U.S.,” Diabetes Care 26 (2003): 1790-95

 

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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