REGRANEX* Gel is formulated with 0.01% becaplermin, a recombinant human platelet-derived growth factor (rh PDGF-BB) formulated in aqueous sodium carboxymethylcellulose-based gel, for topical administration. Prescription required.
• Only FDA-approved platelet-derived growth factor treatment indicated for lower extremity diabetic neuropathic ulcers as an adjunct to good ulcer care
• Promotes wound closure by initiating and supporting the healing process
• Proven to close neuropathic ulcers 32% (6 weeks) faster than placebo gel
• Provided 43% greater incidence of healing in neuropathic ulcers than placebo gel
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.
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).
Limitations of Use:
The efficacy of REGRANEX® Gel has not been established for the treatment of pressure injuries and venous insufficiency 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 primaryintention.
Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use.
Carefully evaluate the benefits of REGRANEX® Gel prior to prescribing in patients with a known malignancy.
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.
If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (eg, patch testing) as dictated by clinical circumstances.
Store refrigerated at 2°C-8°C (36°F-46°F). Do not freeze.
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The amount of REGRANEX® Gel to be applied will vary depending upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters.
Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25cm length of gel squeezed from a 15g tube, or approximately a 0.5cm length of gel from a 2g tube. For example, if the ulcer measures 4cm by 2cm, then a 2cm length of gel should be used for a 15g tube [(4 x 2) / 4 = 2] and a 4cm length of gel should be used for a 2g tube [(4 x 2) / 2 = 4].
The amount of REGRANEX® Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals, depending on the rate of change in ulcer area. The weight of REGRANEX® Gel from 15g tubes is 0.65g per inch length and 0.25g per centimeter length.
To apply REGRANEX® Gel, the calculated length of gel should be squeezed on to a clean measuring surface, eg, wax paper. The measured REGRANEX® Gel is transferred from the clean measuring surface using an application aid and then spread over the entire ulcer area to yield a thin continuous layer of approximately 1/16" thickness. The site(s) of application should then be covered by a saline moistened dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a second moist dressing (without REGRANEX® Gel) for the remainder of the day. REGRANEX® Gel should be applied once daily to the ulcer until complete healing has occurred. 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.
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