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REGRANEX®
(becaplermin) Gel, 0.01%

A recombinant platelet-derived growth factor (PDGF) therapy transforming care for lower extremity diabetic neuropathic ulcer.

REGRANEX (becaplermin) Gel, 0.01% is a product of:

LRM WoundCare

REGRANEX multi-colored diamonds icon
A recombinant platelet-derived growth factor (PDGF) therapy transforming care for lower extremity diabetic neuropathic ulcer.A recombinant platelet-derived growth factor (PDGF) therapy transforming care for lower extremity diabetic neuropathic ulcer.

As rates of diabetes continue to increase, so does the frequency of diabetic foot ulcer (DFU).

An estimated 15% of patients with diabetes are likely to develop a DFU, and 85% of diabetes-related lower extremity amputations are preceded by this condition.

REGRANEX Gel is the only FDA-approved PDGF for the treatment of diabetic neuropathic ulcers, formulated to act as a first-line treatment in conjunction with good ulcer care.

Engineered for growth and healing

REGRANEX’s recombinant pure PDGF formulation initiates the DFU healing process by attracting repair cells to the wound with targeted precision.

A doctor holding a bandage to a patient's foot

REGRANEX (becaplermin) Gel, 0.01% logo

The REGRANEX Healing Process

REGRANEX stimulates tissue growth by promoting fibroblast proliferation, while also enhancing the rate of re-epithelialization and revascularization to facilitate body restoration.

A nurse laughing and smiling with an older woman

An easy, three-step application process

REGRANEX is designed for a flexible, once-daily application schedule as part of effective wound care and assessment, to be applied by either the clinician, caregiver, or patient. Simply prepare, apply, and cover.

REGRANEX gel should be refrigerated when not in use.

“ I have been using Regranex since its launch because it is effective and remains one of a very short list of products with level 1 evidence. I look forward to continuing and expanding usage. ”
Lee Ruotsi
MD, ABWMS, CWS-P, UHM
“ I am very much looking forward to the relaunch of Regranex. I have used it since it was first FDA approved and found it to provide outstanding results when used with appropriate wound bed preparation and patient selection. ”
Gerit Mulder
DPM, PhD
“ I was part of the Ortho-McNeil launch of Regranex in 1998 and learned the difference between wound care and wound healing, and the science behind Regranex is solid. It simply makes sense as a go-to in the well-prepared diabetic foot ulcer. ”
Dot Weir
RN CWON, CWS
“ I have consistently prescribed Regranex since it was FDA approved. Regranex is an integral part of my overall care of patients with diabetic foot ulcers, which includes patient education, appropriate off-loading of the wound area, confirmation of adequate arterial flow, blood glucose control, and wound/peri-wound debridement and bioburden management as needed. ”
Susie Seaman
NP, MSN, CWCN, CWS
REGRANEX® (becaplermin) gel 0.01% 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, as an adjunct to, and not a substitute for, good ulcer care practices. Limitations of Use: Efficacy of REGRANEX has not been established for the treatment of pressure ulcers or venous stasis ulcers, or on exposed joints, tendons, ligaments, and bone in humans. Not intended for use in wounds that close by primary intention. For topical use; not for oral, ophthalmic, or intravaginal use. REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application. REGRANEX contains becaplermin, which promotes cellular proliferation and angiogenesis. Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. If application site reactions occur, consider the possibility of sensitization or irritation due to parabens or m-cresol. Further evaluate, interrupt or discontinue treatment, as appropriate. In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, 8 of 291 subjects (2.7%) from the REGRANEX group and 2 of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% CI). This risk information is not comprehensive. For complete product information, please see the full Prescribing Information.

Important Safety Information

INDICATION

REGRANEX® (becaplermin) gel 0.01% 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, as an adjunct to, and not a substitute for, good ulcer care practices.

Limitations of Use:

Efficacy of REGRANEX has not been established for the treatment of pressure ulcers or venous stasis ulcers, or on exposed joints, tendons, ligaments, and bone in humans. Not intended for use in wounds that close by primary intention.

For topical use; not for oral, ophthalmic, or intravaginal use.

CONTRAINDICATIONS

REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

WARNINGS & PRECAUTIONS

Risk of Cancer. REGRANEX contains becaplermin, which promotes cellular proliferation and angiogenesis. Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use.

Application Site Reactions. If application site reactions occur, consider the possibility of sensitization or irritation due to parabens or m-cresol. Further evaluate, interrupt or discontinue treatment, as appropriate.

ADVERSE REACTIONS

In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, 8 of 291 subjects (2.7%) from the REGRANEX group and 2 of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% CI).

This risk information is not comprehensive. For complete product information, please see the full Prescribing Information.

Lynch Regenerative Medicine
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