Ticalor Special Precautions

Reduced Efficacy with Higher Aspirin Dosage: Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor and should be avoided. After initial dose, use with aspirin 75-100 mg per day.
Bleeding: Like other antiplatelet agents, ticagrelor can cause significant, sometimes fatal bleeding.
Do not use ticagrelor in patients with active pathological bleeding or a history of intracranial hemorrhage.
Do not start ticagrelor in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue ticagrelor at least 5 days prior to any surgery.
Suspect bleeding in any patient receiving ticagrelor who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other invasive procedure, even if no overt manifestations of bleeding are present.
If possible, bleeding should be managed without discontinuing ticagrelor. Stopping ticagrelor increases the risk of subsequent cardiovascular events.
Ticagrelor should be used with caution in patients who are using medicinal products that may increase the risk of bleeding (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics).
No data exist with ticagrelor regarding a hemostatic benefit of platelet transfusions; circulating ticagrelor may inhibit transfused platelets. Since coadministration of ticagrelor with desmopressin did not decrease template bleeding time, desmopressin is unlikely to be effective in managing clinical bleeding events.
Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa therapy may augment hemostasis. Ticagrelor may be resumed after the cause of bleeding has been identified and controlled.
Surgery: If a patient requires surgery, physicians should consider each patient's clinical profile as well as the benefits and risks of continued antiplatelet therapy for determining when discontinuation of ticagrelor treatment should occur.
Because of the reversible binding of ticagrelor, restoration of platelet aggregation occurs faster with ticagrelor compared to clopidogrel. A risk of bleeding complications may be reduced, e.g. in settings where antiplatelet therapy must be temporarily discontinued due to surgery or trauma.
Patients undergoing CABG, ticagrelor had a similar rate of major bleeds compared to clopidogrel at all days after stopping therapy except Day 1 where ticagrelor had a higher rate of major bleeding.
If a patient is to undergo elective surgery and antiplatelet effect is not desired, ticagrelor should be discontinued at least 5 days prior to surgery.
Patients with hepatic impairment: Caution is advised in patients with moderate hepatic impairment because ticagrelor has not been studied in these patients.
Ticagrelor is contraindicated in patients with severe hepatic impairment.
Patients at risk for bradycardic events: Due to observations of mostly asymptomatic ventricular pauses in an earlier clinical study, patients with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2^nd or 3^rd degree AV block or bradycardic-related syncope) were excluded from the main study evaluating the safety and efficacy of ticagrelor. Therefore, due to the limited clinical experience in these patients, caution is advised.
Dyspnoea: Dyspnoea, usually mild to moderate in intensity and often resolving without need for treatment discontinuation, is reported in patients treated with ticagrelor (approximately 13.8%). The mechanism has not yet been elucidated, if a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with ticagrelor should be stopped.
Other: Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor.
Discontinuation of Ticagrelor: Patients who require discontinuation of ticagrelor are at increased risk for cardiac events. Premature discontinuation of treatment should be avoided. If ticagrelor must be temporarily stopped due to an adverse event(s), should be re-initiated as soon as possible when the benefits outweigh the risks of the adverse event or when the adverse event has come to resolution.