BRILIQUE® (ticagrelor)
BRILIQUE (ticagrelor) is the only P2Y12 inhibitor licensed in combination with aspirin to protect patients with prior MI and a high risk* of atherothrombotic events against subsequent CV events in both the acute and long-term treatment settings†1
*High risk is defined as ≥1 additional atherothrombotic risk factor (age ≥65 years, >1 prior MI, multivessel coronary artery disease, diabetes requiring medication, chronic non-end-stage renal dysfunction)1
†BRILIQUE (ticagrelor) 90mg twice daily in combination with acetylsalicylic acid (ASA) is indicated for patients with Acute Coronary Syndromes (ACS) for up to 12 months. BRILIQUE (ticagrelor) 90mg twice daily is not indicated for use in patients beyond 12 months. There are limited data on the efficacy and safety of BRILIQUE (ticagrelor) 60mg beyond 3 years of extended treatment
Brilique Product Information
Warnings and precautions
For a full list of warnings and precautions, please consult the BRILIQUE (ticagrelor) Summary of Product Characteristics, available at http/www.medicines.org.uk.
BRILIQUE (ticagrelor) Contraindications1
- 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), as co-administration may lead to a substantial increase in exposure to ticagrelor
BRILIQUE (ticagrelor) special warnings and precautions1
| Bleeding risk |
Use of BRILIQUE in patients at known increased risk of bleeding should be balanced against benefit in prevention of atherothrombotic events. If clinically indicated, BRILIQUE should be used with caution in patients with:
|
Moderate hepatic impairment |
Caution is advised, as BRILIQUE has not been studied in patients with moderate hepatic impairment. |
| Risk of bradycardia |
Caution is advised in patients with increased risk of bradycardic events (e.g. patients without a pacemaker who have experienced bradycardic related syncope second- or third-degree AV block or sick sinus syndrome), due to limited clinical experience. Caution should be exercised when administering BRILIQUE concomitantly with medicinal products known to induce bradycardia. |
| Surgery |
BRILIQUE should be discontinued 5 days prior to an intervention if a patient is to undergo elective surgery and antiplatelet effect is not desired. |
Patients with prior ischaemic stroke |
ACS patients with prior ischaemic stroke can be treated with BRILIQUE for up to 12 months. Treatment beyond 1 year is not recommended in these patients due to the absence of data. |
| Dyspnoea |
Dyspnoea has been reported in patients treated with BRILIQUE. It is usually mild-to-moderate in intensity and often resolves without need for treatment discontinuation. However, if a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and, if not tolerated, treatment should be stopped. BRILIQUE should be used with caution in patients with a history of asthma and/or COPD, as they may have an increased absolute risk of experiencing dyspnoea. |
| Creatinine elevations |
Creatinine levels may increase during treatment with ticagrelor. The mechanism has not been elucidated. Renal function should be checked according to routine medical practice. In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥ 75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB). |
| Uric acid increase |
Caution is advised in patients with a history of hyperuricaemia or gouty arthritis. As a precautionary measure, the use of BRILIQUE in patients with uric acid nephropathy is discouraged. |
| High maintenance-dose aspirin (>300 mg) | Co-administration of BRILIQUE and high maintenance-dose ASA (>300 mg) is not recommended. |
| Premature discontinuation | Premature discontinuation with any antiplatelet therapy could result in an increased risk of CV death, MI or stroke due to the patient's underlying disease. Therefore, premature discontinuation of treatment should be avoided. |
| Pregnancy and lactation | Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during ticagrelor therapy. Ticagrelor is not recommended during pregnancy and/or breastfeeding. |
| Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely with the use of ticagrelor. It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis |
ACS, acute coronary syndrome; ARB, angiotensin receptor blocker; ASA, acetylsalicylic acid; AV,atrioventricular; COPD, chronic obstructive pulmonary disease; CV, cardiovascular; GI, gastrointestinal; MI,myocardial infarction; NSAID, non-steroidal anti-inflammatory drug.