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 The following adverse reactions are described elsewhere in the labeling: Methemoglobinemia [see Warnings and Precautions (5.1) ] Overexposure [see Warnings and Precautions (5.2) ] Risks of Secondary Exposure in Children and Pets [see Warnings and Precautions (5.3) ] Anaphylactic Reactions [see Warnings and Precautions (5.4) ] Eye Irritation [see Warnings and Precautions (5.5) ] Most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IPG Pharmaceuticals, Inc.
at 1-888-711-7116 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.
However, the adverse reaction information from clinical trials does provide a basis for identifying the adverse events that appear to be related to drug use and for approximating their incidence in clinical practice.
PLIAGLIS has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure.
PLIAGLIS was studied in 11 placebo-controlled and 1 active-controlled trials, and in open-label safety trials.
All 2159 persons were exposed to only a single application of PLIAGLIS.
Adverse reactions were assessed by collecting spontaneously reported adverse reactions, and observations made on formal evaluation of the skin for specific reactions.
Most common adverse reactions in clinical trials Localized Reactions: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (e.g., blanching, ecchymosis, and purpura) (16%), and edema (14%).
5 WARNINGS AND PRECAUTIONS Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use.
( 5.1 ) Overexposure : To avoid overexposure that could lead to adverse effects, do not use for longer duration or over larger surface areas than recommended.
( 5.2 ) consider total amount of local anesthetics absorbed from all formulations.
( 5.2 ) do not apply to mucous membranes or broken or inflamed skin.
( 5.2 ) use with caution in patients who may be more sensitive to systemic effects of PLIAGLIS, including acutely ill or debilitated or those with severe hepatic disease or pseudocholinesterase deficiency.
Like all medications, Pliaglis 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: