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 serious adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Boxed Warning and Warnings and Precautions (5.1 , 5.2) ] Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions (5.4) ] Hypersensitivity Including Angioedema [see Warnings and Precautions (5.5) ] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (60 mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months;
4136 patients were treated for more than 1 year).
The population treated with Effient was 27 to 96 years of age, 25% female, and 92% Caucasian.
All patients in the TRITON-TIMI 38 study were to receive aspirin.
The dose of clopidogrel in this study was a 300 mg loading dose and 75 mg once daily.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with the rates observed in other clinical trials of another drug and may not reflect the rates observed in practice.
Drug Discontinuation The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel.
5 WARNINGS AND PRECAUTIONS CABG-related bleeding: Risk increases in patients receiving Effient who undergo CABG ( 5.2 ).
Discontinuation of Effient: Premature discontinuation increases risk of stent thrombosis, MI, and death ( 5.3 ).
Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Effient ( 5.4 ).
Hypersensitivity: Hypersensitivity including angioedema has been reported with Effient including in patients with a history of hypersensitivity reaction to other thienopyridines ( 5.5 ).
5.1 General Risk of Bleeding Thienopyridines, including Effient, increase the risk of bleeding.
Like all medications, Effient 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: