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 also discussed elsewhere in the labeling: •Bleeding [see Warnings and Precautions ( 5.1 )] •Dyspnea [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (>5%) are bleeding and dyspnea.
( 5.1 , 5.3 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088or www .fda.gov/medwatch.
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.
Ticagrelor has been evaluated for safety in more than 58,000 patients.
Bleeding in PLATO (Reduction in risk of thrombotic events in ACS) Figure 1 is a plot of time to the first non-CABG major bleeding event.
Figure 1- Kaplan-Meier estimate of time to first non-CABG PLATO-defined major bleeding event (PLATO) Frequency of bleeding in PLATO is summarized in Tables 1 and
About half of the non-CABG major bleeding events were in the first 30 days.
Table 1 - Non-CABG related bleeds (PLATO) Ticagrelor * N=9235 Clopidogrel N=9186 n (%) patients with event n (%) patients with event PLATO Major + Minor 713 (7.7) 567 (6.2) Major 362 (3.9) 306 (3.3) Fatal/Life-threatening 171 (1.9) 151 (1.6) Fatal 15 (0.2) 16 (0.2) Intracranial hemorrhage (Fatal/Life-threatening) 26 (0.3) 15 (0.2) PLATO Minor bleed: requires medical intervention to stop or treat bleeding.
PLATO Major bleed : any one of the following: fatal;
5 WARNINGS AND PRECAUTIONS • Dyspnea was reported more frequently with ticagrelor than with control agents in clinical trials.
Dyspnea from ticagrelor is self-limiting.
( 5.3 ) •Severe Hepatic Impairment: Likely increase in exposure to ticagrelor.
( 5.5 ) •Laboratory Test Interference: False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT).
Ticagrelor is not expected to impact PF4 antibody testing for HIT.
Like all medications, Ticagrelor 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: