
Healthcare Professional Important Safety Information
REGRANEX Gel is contraindicated in patients with
neoplasms at the site of application. An increased risk of mortality
secondary to malignancy remote from the site of treatment has been
observed in patients treated with 3 or more tubes of REGRANEX Gel in a
post-marketing retrospective cohort study. (See Boxed WARNING).
However, in a separate analysis of cancer incidence, these results were
consistent with no overall increase in cancer incidence (See WARNINGS).
REGRANEX Gel should be used with caution in patients with known
malignancy. REGRANEX Gel is contraindicated in patients with known
hypersensitivity to any component of this product (eg, parabens).
Erythematous rashes occurred in 2% of patients treated with REGRANEX
Gel or placebo gel. REGRANEX Gel should not be used in wounds that
close by primary intention.
All full U.S. Prescribing Information on this website is in Adobe®
Acrobat® form. (If you need to download the Adobe Acrobat Reader,
please click here. This link will take you to a website to which this Privacy Policy
does not apply. You are solely responsible for your interactions with
such websites.) If you need information about any SYSTAGENIX
Wound Management product, please contact your doctor, pharmacist, or
other healthcare professional. You can also call the REGRANEX Gel
Clinical Communication Center, 1-888-REGRANEX, 8:30 a.m. - 4:30 p.m.
(EST).
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