Loading…
Prasugrel Viatris (Previously Prasugrel Mylan) is a brand name for Prasugrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI])…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults Prasugrel Viatris should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. 1). Patients taking Prasugrel Viatris should also take ASA daily (75 mg to 325 mg). In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Prasugrel Viatris, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’s underlying disease.
1). Patients ≥75 years old The use of Prasugrel Viatris in patients ≥75 years of age is generally not recommended. 4), treatment is deemed necessary in the patients age group ≥75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
2). Patients weighing <60 kg Prasugrel Viatris should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose. The 10 mg maintenance dose is not recommended. 2). 2). 4). 2). 4). Prasugrel Viatris is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Paediatric population The safety and efficacy of Prasugrel Viatris in children below age 18 has not been established. 1). Method of administration Prasugrel Viatris is for oral use. It may be administered with or without food. 2). The tablets should not be crushed or broken.
Other brands of Prasugrel in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 months (5,802 patients were treated for over 6 months; 4,136 patients were treated for more than 1 year). 3% for clopidogrel. 4% for clopidogrel). Bleeding Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations.
No significant difference was seen in the STEMI population. 2% with clopidogrel). 6 a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. b Other standard therapies were used as appropriate.
c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL. d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below. Patients may be counted in more than one row.
e ICH = intracranial haemorrhage. f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL. 1% for clopidogrel. CABG-related bleeding In the phase 3 clinical study, 437 patients underwent CABG during the course of the study.
5% in the clopidogrel group. The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study medicinal product. 0% (3 of 60 patients) in the clopidogrel group. 4% (3 of 89 patients) in the clopidogrel group.
4). 4). 6 10/43 a Other standard therapies were used as appropriate. The […]
Bleeding risk In the phase 3 clinical study (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings. Patients with acute 4/43 coronary syndromes undergoing PCI treated with prasugrel and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.
Therefore, the use of prasugrel in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings. This concern applies especially to patients: • ≥75 years of age (see below).
g. 8). In these patients the 10 mg maintenance dose is not recommended. A 5 mg maintenance dose should be used. • with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
For patients with active bleeding for whom reversal of the pharmacological effects of prasugrel is required, platelet transfusion may be appropriate. The use of Prasugrel Viatris in patients ≥75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
In the phase 3 clinical study these patients were at greater risk of bleeding, including fatal bleeding, compared to patients <75 years of age. 8). Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
These patients may have an increased bleeding risk. Therefore, prasugrel should be used with caution in these patients. Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Bleeding risk associated with timing of loading dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri- procedural bleeding compared with a prasugrel loading dose at the time of PCI.
Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. 1). Surgery Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Prasugrel Viatris should be discontinued at least 7 days prior to surgery. 8). The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Hypersensitivity including angioedema Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel. 8). 5/43 Thrombotic thrombocytopaenic purpura (TTP) TTP has been reported with the use of prasugrel.
TTP is a serious condition and requires prompt treatment. 5). Prasugrel Viatris 5 mg contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Prasugrel Viatris 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
1. Active pathological bleeding. History of stroke or transient ischaemic attack (TIA). Severe hepatic impairment (Child Pugh class C).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.