BRILINTA- ticagrelor tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cardinal Health 107, LLC

INN (International Nazwa):

TICAGRELOR

Skład:

TICAGRELOR 90 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 ICH in this population [see Clinical Studies (14.1), (14.2)]. BRILINTA is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] . BRILINTA is contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product. Risk Summary Available data from case reports with BRILINTA use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area. When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD (see DATA). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m2 basis. Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae. At the mid-dose of 100 mg/kg/day (5.5 times the MRHD on a mg/m2 basis), delayed development of liver and skeleton was seen. When pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the MRHD on a mg/m2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred. In a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation. Pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the MRHD on a mg/m2 basis). Relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the MRHD on a mg/m2 basis). Risk Summary There are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Breastfeeding is not recommended during treatment with BRILINTA. The safety and effectiveness of BRILINTA have not been established in pediatric patients. Effectiveness was not demonstrated in an adequate and well-controlled study conducted in 101 BRILINTA-treated pediatric patients, aged 2 to <18 for reducing the rate of vaso-occlusive crises in sickle cell disease. About half of the patients in PLATO, PEGASUS, THEMIS, and THALES were ≥65 years of age and at least 15% were ≥75 years of age. No overall differences in safety or effectiveness were observed between elderly and younger patients. Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Avoid use of BRILINTA in patients with severe hepatic impairment. There is limited experience with BRILINTA in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor. No dosage adjustment is needed in patients with mild hepatic impairment [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)] . No dosage adjustment is needed in patients with renal impairment [see Clinical Pharmacology (12.3)] . Patients with End-Stage Renal Disease on dialysis Clinical efficacy and safety studies with BRILINTA did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, no clinically significant difference in concentrations of ticagrelor and its metabolite and platelet inhibition are expected compared to those observed in patients with normal renal function [see Clinical Pharmacology (12.3)] . It is not known whether these concentrations will lead to similar efficacy and safety in patients with ESRD on dialysis as were seen in PLATO, PEGASUS, THEMIS and THALES.

Podsumowanie produktu:

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet with a “90” above “T” on one side: Overbagged with 10 tablets per bag, NDC 55154-9618-0 Approximately 1440 tablets per bottle, NDC 55154-9618-8 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].

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

Cardinal Health 107, LLC
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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 over-the

Charakterystyka produktu

BRILINTA- TICAGRELOR TABLET
CARDINAL HEALTH 107, LLC
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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
•
•
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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 Scale sc