APMA News - September/October 2022 - 74

Back in stock.
Permanently.
Now manufactured at our
facility in Fort Worth, TX
The inconsistent availability of REGRANEX has
been met by a definitive response. Get it when your
patients need it and get it more affordably than
you think
* No more supply issues for you and your patients
* No more worrying about product availability
* No more turning to other treatments
Now you can reliably
make REGRANEX a first
line in your DFU protocol.
Scan to find out more information
Indications: REGRANEX (becaplermin) gel 0.01% ( " REGRANEX " ) is a prescription only medication 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, an not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.
Contraindications: REGRANEX 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 occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX
contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The
efficacy of REGRANEX 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 or ischemic diabetic ulcers.
The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile,
low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention. 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, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group
were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three
or more tubes of REGRANEX, observed in one of three retrospective postma keting studies. Other adverse reactions that have been reported
include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the
complete prescribing information, please see the FDA-approved product labeling, here: https://regranex.com/pdf/PI_Full_Version.pdf. You are
encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
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APMA News - September/October 2022

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