Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Erythematous rashes occurred in 2% of patients treated with REGRANEX.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Lynch Regenerative Medicine, LLC at 1-888-576-7343 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care), and none in subjects receiving good ulcer care alone.
Subjects treated with REGRANEX did not develop neutralizing antibodies against becaplermin.
In a retrospective follow-up study of 491 of 651 subjects (75%) from two randomized, controlled trials of another formulation of becaplermin gel 0.01%, the subjects were followed for a median of approximately 20 months to evaluate safety and recurrence of healed diabetic lower extremity ulcers.
Eight of 291 subjects (2.7%) from the becaplermin gel group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval [CI], 0.6-12.8).
The types of cancers varied and all were remote from the treatment site [see Warnings and Precautions ( 5.1 )] .
6.2 Postmarketing Experience Because post-approval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
The following adverse reactions have been identified during post approval use of REGRANEX.
Increased rate of death from systemic malignancies in patients dispensed 3 or more tubes of REGRANEX was observed in one of three retrospective postmarketing studies [ see Clinical Studies ( 14.3 ) ].
5 WARNINGS AND PRECAUTIONS Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use.
( 5.1 ) The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy.
( 5.1 ) 5.1 Risk of Cancer REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis [ see Clinical Pharmacology ( 12.1 ) ].
Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use [ see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 ) ].
The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy.
Like all medications, Regranex Gel 0.01% can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: