Label Changes for:

Brilinta (ticagrelor) Tablets

December 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

December 2013

ADVERSE REACTIONS

DRUG INTERACTIONS

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

 

March 2013

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

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.”

 

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