Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces the introduction of Regranex360◊, a comprehensive new program to support patients in the US using REGRANEX◊ Gel. REGRANEX Gel is the first and only FDA-approved platelet-derived growth factor (PDGF) therapy indicated as an adjunct to good ulcer care for the treatment of lower extremity diabetic neuropathic ulcers.1
“We are very pleased to introduce the Regranex360 program as part of our ongoing commitment to offer evidence-based biologic therapeutics along with best-in-class provider and patient support programs to the wound care market,” said Rob Bancroft, President of Smith & Nephew Biotherapeutics. “In particular, we are delighted to streamline and enhance the REGRANEX Gel patient experience with a program designed to help each individual stay on track with their treatment.”
Regranex360 is a full service online portal designed to simplify the prior authorization and product acquisition process. In addition, to promote compliance and adherence to REGRANEX Gel, Regranex360 provides each patient with a care coordinator they can contact via phone throughout their entire course of therapy.
Regranex360 is simple to use and access. Clinicians submit enrollment forms either through Regranex360.com or via fax. Regranex360 then obtains prior authorization approval and forwards the prescription to an appropriate pharmacy. A patient care coordinator will contact the patient to schedule delivery, provide education and answer any questions about treatment. Patients can also contact the Regranex360 hotline with any questions during their course of therapy.
Regranex360.com is available to prescribers and patients 24 hours a day, 7 days a week; the hotline, 1-888-REGRANEX (734-7263) is accessible Monday through Friday, 8:00am to 7:00pm EST.
In addition to the Regranex360 program, Smith & Nephew Biotherapeutics has also launched a new REGRANEX Gel Web site (www.Regranex.com) that highlights features of the product, including clinical research, provides a dosing calculator and offers additional tips for patients.
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 three or more tubes of REGRANEX Gel in a post-marketing 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. |
Indications and usage:
REGRANEX (becaplermin) Gel, 0.01% 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.
Limitations of use:
- The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis 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 that should not be used in wounds that close by primary intention
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.
In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo; none occurred in patients receiving good ulcer care alone.
Please see Full Prescribing Information with Boxed Warning and Important Safety Information at www.Regranex.com.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2012 were more than $4.1 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
Forward-looking Statements
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1. REGRANEX Gel Prescribing Information.
2. 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. Diabetes Care. 1998;21(5):822-827.