Prasugrel oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing prasugrel.
Drugs List
Therapeutic Indications
Uses
Adjunct to prevent atherothrombotic events in ACS patients undergoing PCI
Dosage
Patients receiving prasugrel treatment should also receive aspirin daily.
A treatment of up to 12 months is recommended unless discontinuation is clinically indicated.
Adults
Patients weighing 60kg and over
Initially a single loading dose of 60mg, followed by a maintenance dose of 10mg once a day for up to 12 months.
Patients weighing less than 60kg
Initially a single loading dose of 60mg, followed by a maintenance dose of 5mg once a day for up to 12 months.
The 10mg maintenance dose is not recommended in patients weighing less than 60kg, as these patients have an increased exposure to the active metabolite of prasugrel. Patients weighing less than 60kg had an increased risk of bleeding compared with patients weighing 60kg or above when given the 10mg dose. The efficacy and safety of the 5mg dose have not been prospectively assessed.
Elderly
The use of prasugrel in patients aged 75 years or over is not recommended. Treatment should only be initiated after careful individual benefit/risk evaluation. The dose should follow the regimen below, with the lower maintenance dose.
Initially a single loading dose of 60mg, followed by a maintenance dose of 5mg once a day for up to 12 months.
Patients aged 75 years or over are more sensitive to bleeding and have greater exposure to the active metabolite of prasugrel.
Additional Dosage Information
The onset of action of the 60mg loading dose may be most rapid when given to the patients in a fasted state.
Contraindications
Children under 18 years
Haemorrhage
Breastfeeding
History of cerebrovascular accident
History of transient ischaemic attack
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Precautions and Warnings
Patients over 75 years
Recent surgery
Recent trauma
Risk of haemorrhage
Weight below 60kg
Anaemia
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of gastrointestinal bleeding
History of intracranial disorder
Lactose intolerance
Peptic ulcer
Pregnancy
Renal impairment
Thrombocytopenia
Before initiating therapy enquire about previous hypersensitivity reactions
Some formulations contain lactose
Monitor for hypersensitivity reactions - risk of severe reactions
Reduce dose in patients who weigh less than 60kg
Refer if thrombotic thrombocytopenic purpura suspected to a specialist
Advise on the need to report unusual bleeding
Contact doctor immediately with any signs of hypersensitivity reactions
Discontinue 7 days prior to surgery when antiplatelet effect not required
Reduce dose in elderly
Avoid premature discontinuation - usual duration is 12 months
Advise patient not to take NSAIDs unless advised by clinician
Advise patient of risk of bleeding
Advise patient to inform physician/dentist of their use of this medication
Platelet transfusion may be appropriate for patients who develop active bleeding while receiving prasugrel.
The benefits and risks of prasugrel treatment should be carefully considered prior to commencing treatment in patients whose coronary anatomy is not well defined and who may require urgent CABG surgery.
Premature discontinuation of prasugrel should be avoided unless clinically indicated. Premature discontinuation could result in an increased risk of thrombosis, myocardial infarction or death from the patient's underlying disease.
Pregnancy and Lactation
Pregnancy
Use prasugrel with caution during pregnancy.
The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus. Animal studies have not indicated direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. At the time of writing, there is little published experience concerning exposed human pregnancies and their outcomes. Potential risks are unknown.
Lactation
Prasugrel is contraindicated during breastfeeding.
The manufacturer notes that the use of prasugrel during breastfeeding is not recommended. At the time of writing, there is little published experience concerning the use of prasugrel during breastfeeding. Animal studies have shown excretion of prasugrel into breast milk. It is unknown whether prasugrel is excreted into human breast milk.
Side Effects
Anaemia
Angioedema
Bleeding
Contusion
Ecchymosis
Epistaxis
Gastro-intestinal haemorrhage
Gingival bleeding
Haematochezia
Haematoma
Haematoma (injection site)
Haematuria
Haemoptysis
Haemorrhage (injection site)
Hypersensitivity reactions
Intracranial bleeding
Ocular haemorrhage
Post operative wound haemorrhage
Rash
Rectal haemorrhage
Retroperitoneal bleeding
Subcutaneous haemorrhage
Thrombocytopenia
Thrombotic thrombocytopenic purpura
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Efient 5mg film-coated tablets. Daiichi Sankyo UK Limited. Revised November 2018.
Summary of Product Characteristics: Efient 10mg film-coated tablets. Daiichi Sankyo UK Limited. Revised November 2018.
Summary of Product Characteristics: Prafsia 5mg film-coated tablets. Northumbria Pharma Ltd. Revised February 2019.
Summary of Product Characteristics: Prafsia 10mg film-coated tablets. Northumbria Pharma Ltd. Revised March 2019.
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