Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
BOXED WARNING - updated
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
A. BLEEDING RISK
- Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
- Do not use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage
- Do not start Brilinta in patients undergoing urgent coronary artery bypass graft surgery (CABG)
- If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
- Maintenance doses of aspirin above 100 mg reduce the effectiveness of Brilinta and should be avoided
Effects on Other Drugs
- Ticagrelor is also a p-glycoprotein (P-gp) substrate.
- BRILINTA is contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product
WARNINGS AND PRECAUTIONS
- ….but occasionally required discontinuation (0.9% of patients taking BRILINTA versus 0.1% of patients taking clopidogrel .... In the case of intolerable dyspnea requiring discontinuation of Brilinta, consider prescribing another antiplatelet agent.
- BRILINTA is contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product [see Adverse Reactions (6.2)]
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- The following adverse reactions have been identified during post-approval use of BRILINTA. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Immune system disorders – Hypersensitivity reactions including angioedema [see Contraindications (4.4)]
Who should not take Brilinta? the following bullet was added:
- "are allergic to ticagrelor or any of the ingredients in BRILINTA. See the end of this Medication Guide for a list of ingredients in BRILINTA.”