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  • Brilinta
    / Astra Zeneca

    Active Ingredient
    Ticagrelor 60 mg, 90 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    56 X 60 mg

    partial basket chart 53183

    Film Coated Tablets

    56 X 90 mg

    partial basket chart 15216 2523

    Film Coated Tablets

    168 X 90 mg

    partial basket chart 152226 2524


    Patients taking BRILINTA should also take ASA daily, unless specifically contraindicated.
    Following an initial dose of ASA, BRILINTA should be used with a maintenance dose of ASA of 75-150 mg.
    Acute coronary syndromes: BRILINTA treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily.
    Treatment with Brilinta 90mg twice daily is recommended for up to 12 months in ACS patinets unless discontinuation is clinically indicated.
    History of myocardial infarction: Brilinta 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event. Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Brilinta 90 mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event. Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment. There are limited data on the efficacy and safety of Brilinta beyond 3 years of extended treatment. Therefore Brilinta should not be used for more than 36 months.
    If a switch is needed, the first dose of Brilinta should be administered 24 hours following the last dose of the other antiplatelet medication.
    In patients with Acute Coronary Syndromes (ACS), premature discontinuation with any antiplatelet therapy, including BRILINTA, could result in an increased risk of cardiovascular death, or myocardial infarction due to the patient’s underlying disease.
    Therefore, premature discontinuation of treatment should be avoided.
    Missed dose: Lapses in therapy should also be avoided. A patient who misses a dose of BRILINTA should take only one 90 mg tablet (their next dose) at its scheduled time.
    Elderly population: No dose adjustment is required in elderly.
    Renal impairment: No dose adjustment is necessary for patients with renal impairment. No information is available concerning treatment of patients on renal dialysis and therefore Brilinta is not recommended in these patients.
    Hepatic impairment: BRILINTA has not been studied in patients with severe hepatic impairment and its use in patients with moderate to severe hepatic impairment is therefore contraindicated. Only limited information is available in patients with moderate hepatic impairment. Dose adjustment is not recommended, but ticagrelor should be used with caution. No dose adjustment is necessary for patients with mild hepatic impairment.
    Paediatric population: The safety and efficacy of BRILINTA in children below the age of 18 in the approved adult indication has not been established. No data are available.
    Method of administration: For oral use. BRILINTA can be administered with or without food.
    For patients who are unable to swallow the tablet(s) whole, Brilinta tablets (90 mg and 2×90 mg) can be crushed to a fine powder and mixed in half a glass of water and drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture.


    Co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with
    – acute coronary syndromes (ACS) or
    – a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
    Limitations of use: 90 mg twice daily during the first year after an ACS event followed by 60 mg twice daily for additional 2 years.


    Hypersensitivity to the active substance or to any of the excipients.
    Active pathological bleeding.
    History of intracranial haemorrhage.
    Severe hepatic impairment.
    Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor.

    Special Precautions

    Bleeding risk: The use in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events. Should be used with caution in the following patient groups: Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding). The use of BRILINTA is contraindicated in patients with active pathological bleeding, in those with a history of intracranial haemorrhage, and in patients with moderate to severe hepatic impairment.
    Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of BRILINTA dosing.
    Since co-administration of BRILINTA with desmopressin did not decrease template-bleeding time, desmopressin is unlikely to be effective in managing clinical bleeding events.
    Surgery: Patients should be advised to inform physicians and dentists that they are taking Brilinta before any surgery is scheduled and before any new medicinal product is taken. If a patient is to undergo elective surgery and antiplatelet effect is not desired BRILINTA should be discontinued 7 days prior to surgery.
    Hepatic impairment: Use of Brilinta is contraindicated in patients with severe hepatic impairment.
    Dyspnoea: Dyspnoea was reported in patients treated with Brilinta. Dyspnoea is usually mild to moderate in intensity and often resolves without need for treatment discontinuation. Patients with asthma/COPD may have an increased absolute risk of experiencing dyspnoea with Brilinta. Brilinta should be used with caution in patients with history of asthma and/or COPD. The mechanism has not been elucidated. If a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with Brilinta should be stopped.
    See prescribing information for full details.




    Side Effects

    Very common: Blood disorder, Bleedings, Hyperuricaemia, Dyspnoea.
    Common: Gout / Gouty Arthrities, Dizziness, Headache, Syncope, Vertigo, Hypotension, Respiratory system bleedings, Gastrointestinal
    haemorrhage, Diarrhoea, Dyspepsia, Nausea, Constipation, Subcutaneous or
    dermal bleeding, Rash, Pruritus, Urinary tract bleeding, Blood creatinine increased, Post procedural haemorrhage, Traumatic bleedings.
    See prescribing information for full details.

    Drug interactions

    Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CYP3A4. Ticagrelor is also a P-gp substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
    See prescribing information for full details.

    Pregnancy and Lactation

    Women of childbearing potential: Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during BRILINTA therapy.
    There are no or limited amount of data from the use of ticagrelor in pregnant women. Studies in animals have shown reproductive toxicity. BRILINTA is not recommended during pregnancy.
    Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of ticagrelor and its active metabolites in milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from BRILINTA therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.


    Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study. Other clinically meaningful adverse reactions which may occur with overdose include dyspnoea and ventricular pauses.
    In the event of overdose, the above potential adverse reactions could occur and ECG monitoring should be considered.
    There is currently no known antidote to reverse the effects of BRILINTA, and BRILINTA is not expected to be dialysable. Treatment of overdose should follow local standard medical practice. The expected effect of excessive BRILINTA dosing is prolonged duration of bleeding risk associated with platelet inhibition. If bleeding occurs appropriate supportive measures should be taken.

    Important notes

    Shelf life: 3 years.
    Storage: do not store above 30°C.

    AstraZeneca AB Gärtunavägen Sweden