BRILINTA- ticagrelor tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TICAGRELOR (UNII: GLH0314RVC) (TICAGRELOR - UNII:GLH0314RVC)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

TICAGRELOR

Composition:

TICAGRELOR 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BRILINTA is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1)] . BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2)] . While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3)] . BRILINTA is contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent I

Product summary:

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet with a “90” above “T” on one side: Bottles of 60 – NDC 0186-0777-60 100 count Hospital Unit Dose – NDC 0186-0777-39 BRILINTA (ticagrelor) 60 mg is supplied as a round, biconvex, pink, film-coated tablet with a “60” above “T” on one side: Bottles of 60 – NDC 0186-0776-60 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature].

Authorization status:

New Drug Application

Patient Information leaflet

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
BRILINTA® (brih-LIN-tah)
(ticagrelor) Tablets
What is the most important information I should know about BRILINTA?
BRILINTA is used to lower your chance of having, or dying from, a
heart attack or stroke. BRILINTA (and
similar drugs) can cause bleeding that can be serious and sometimes
lead to death. In cases of serious
bleeding, such as internal bleeding, the bleeding may result in the
need for blood transfusions or surgery.
While you take BRILINTA:
•
you may bruise and bleed more easily
•
you are more likely to have nose bleeds
•
it will take longer than usual for any bleeding to stop
Call your doctor right away, if you have any of these signs or
symptoms of bleeding while taking
BRILINTA:
•
bleeding that is severe or that you cannot control
•
pink, red or brown urine
•
vomiting blood or your vomit looks like “coffee grounds”
•
red or black stools (looks like tar)
•
coughing up blood or blood clots
Do not stop taking BRILINTA without talking to the doctor who
prescribes it for you. People who are
treated with a stent, and stop taking BRILINTA too soon, have a higher
risk of getting a blood clot in the
stent, having a heart attack, or dying. If you stop BRILINTA because
of bleeding, or for other reasons, your
risk of a heart attack or stroke may increase.
Your doctor may instruct you to stop taking BRILINTA 5 days before
surgery. This will help to decrease
your risk of bleeding with your surgery or procedure. Your doctor
should tell you when to start taking
BRILINTA again, as soon as possible after surgery.
Taking BRILINTA with aspirin
BRILINTA is taken with aspirin. Talk to your doctor about the dose of
aspirin that you should take with
BRILINTA. In most cases, you should not take a dose of aspirin higher
than 100 mg daily because it can
affect how well BRILINTA works. Do not take doses of aspirin higher
than what your doctor tells you to
take. Tell your doctor if you take other medicines that contain
aspirin, and do not take new ov

Summary of Product characteristics

BRILINTA- TICAGRELOR TABLET
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRILINTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRILINTA.
BRILINTA® (TICAGRELOR) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: (A) BLEEDING RISK, AND (B) ASPIRIN DOSE AND BRILINTA
EFFECTIVENESS
IN PATIENTS WITH ACS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
BLEEDING RISK
•
•
•
•
ASPIRIN DOSE AND BRILINTA EFFECTIVENESS IN PATIENTS WITH ACS
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.7) 08/2021
INDICATIONS AND USAGE
BRILINTA is a P2Y12 platelet inhibitor indicated
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
BRILINTA, LIKE OTHER ANTIPLATELET AGENTS, CAN CAUSE SIGNIFICANT,
SOMETIMES FATAL
BLEEDING. (5.1, 6.1)
DO NOT USE BRILINTA IN PATIENTS WITH ACTIVE PATHOLOGICAL BLEEDING OR A
HISTORY OF
INTRACRANIAL HEMORRHAGE. (4.1, 4.2)
DO NOT START BRILINTA IN PATIENTS UNDERGOING URGENT CORONARY ARTERY
BYPASS GRAFT
SURGERY (CABG). (5.1, 6.1)
IF POSSIBLE, MANAGE BLEEDING WITHOUT DISCONTINUING BRILINTA. STOPPING
BRILINTA
INCREASES THE RISK OF SUBSEQUENT CARDIOVASCULAR EVENTS. (5.4)
MAINTENANCE DOSES OF ASPIRIN ABOVE 100 MG DAILY REDUCE THE
EFFECTIVENESS OF
BRILINTA AND SHOULD BE AVOIDED. (2, 5.2, 14.1)
to reduce the risk of cardiovascular (CV) death, myocardial infarction
(MI), and stroke in patients with
acute coronary syndrome (ACS) or a history of MI. For at least the
first 12 months following ACS, it is
superior to clopidogrel.
BRILINTA also reduces the risk of stent thrombosis in patients who
have been stented for treatment of
ACS. (1.1)
to reduce the risk of a first MI or stroke in patients with coronary
artery disease (CAD) at high risk for
such events. While use is not limited to this setting, the efficacy of
BRILINTA was established in a
population with type 2 diabetes mellitus (T2DM). (1.2)
to reduce the risk of stroke in patients with acute ischemic stroke
(NIH Stroke Sc