Safety

Brilinta (ticagrelor) 90 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

Summary View

ADVERSE REACTIONS

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.
    • Immune system disorders: Hypersensitivity reactions including angioedema
    • Skin and subcutaneous tissue disorders: Rash

 

September 2015

Summary View

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

 

December 2013

Summary View

ADVERSE REACTIONS

DRUG INTERACTIONS

 Effects on Other Drugs
  • Ticagrelor is also a p-glycoprotein (P-gp) substrate.

 

March 2013

Summary View

CONTRAINDICATIONS

Hypersensitivity
  • BRILINTA is contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product

WARNINGS AND PRECAUTIONS

Dyspnea
  • ….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.

 

January 2013

Summary View

4 CONTRAINDICATIONS

4.4 Hypersensitivity
  • 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)]

MEDICATION GUIDE

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.”

 

Page Last Updated: 08/15/2016
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