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P2Y12 ADP Receptor Antagonist (Thienopyridine Prodrug)

Prasugrel (P2Y12 Antiplatelet — ACS/PCI)

Brand names: Efient

Prasugrel is an oral P2Y12-receptor antiplatelet used with aspirin (dual antiplatelet therapy) in patients with acute coronary syndrome who are managed with percutaneous coronary intervention.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Acute coronary syndrome managed with PCI (with aspirin) — oral loading dose 60 mg as a single dose, then maintenance 10 mg once a day. Reduced maintenance dose 5 mg once daily in patients weighing <60 kg, and in patients ≥75 years if treatment is judged necessary after individual benefit/risk evaluation (the 60 mg loading dose is unchanged in both groups).
Route: Oral — 'Efient may be administered with or without food'; 'Do not crush or break the tablet.' Indication for this dose: acute coronary syndrome (unstable angina / NSTEMI / STEMI) managed with percutaneous coronary intervention, co-prescribed with aspirin.
Frequency: Loading dose once at initiation, then 10 mg (or 5 mg) once daily. 'A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated.' Timing: 'In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI.'
Max: Maximum maintenance dose 10 mg once daily (SPC §4.2: 'continued at 10 mg once a day'). In patients weighing <60 kg and in patients ≥75 years the SPC states 'The 10 mg maintenance dose is not recommended' — 5 mg once daily is the ceiling in those groups. The 60 mg loading dose is a single dose given once at initiation and is not a daily maximum.
Verbatim SPC §4.2: 'Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.' Aspirin co-therapy: 'Patients taking Efient should also take ASA daily (75 mg to 325 mg).' Fasted loading: 'Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action.' Low body weight: 'Efient 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. This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg.' Age ≥75: 'The use of Efient in patients ≥ 75 years of age is generally not recommended. If, after a careful individual benefit/risk evaluation by the prescribing physician, 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.' Discontinuation: 'premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death'. US label agrees on 60 mg load / 10 mg daily and says 'Consider lowering the maintenance dose to 5 mg in patients <60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied.' Tablet strengths available: 5 mg and 10 mg. PAEDIATRICS: §4.2 'The safety and efficacy of Efient in children below age 18 has not been established' — hence paedDose is null.

Dose adjustments

Renal

§4.2: 'No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease. There is limited therapeutic experience in patients with renal impairment.' §4.4 adds that experience is limited in renal impairment (including ESRD) and 'These patients may have an increased bleeding risk. Therefore, prasugrel should be used with caution in these patients.'

Hepatic

§4.2: 'No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B). There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction. Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).'

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (§4.3)
  • Active pathological bleeding
  • History of stroke or transient ischaemic attack (TIA)
  • Severe hepatic impairment (Child Pugh class C)

Side effects

  • Bleeding — the most common adverse reaction and the commonest cause of discontinuation (2.5% for prasugrel vs 1.4% for clopidogrel in TRITON) (§4.8)
  • Non-CABG-related TIMI major bleeding 2.2% (all ACS) vs 1.7% on clopidogrel; life-threatening 1.3% vs 0.8%; fatal 0.3% vs 0.1%; TIMI minor bleeding 2.4% vs 1.9%
  • Symptomatic intracranial haemorrhage 0.3% (same rate as clopidogrel in TRITON)
  • Gastrointestinal bleeding — the most common site of spontaneous bleeding (1.7% vs 1.3% on clopidogrel)
  • Arterial puncture site bleeding — the most frequent site of provoked bleeding (1.3% vs 1.2% on clopidogrel)
  • Markedly higher bleeding in the elderly on the 10 mg dose: non-CABG TIMI major or minor bleeding 9.0% (1.0% fatal) in patients ≥75 years on prasugrel 10 mg vs 3.8% (0.2% fatal) in those <75 years; on the 5 mg dose, 2.6% (0.3% fatal) in patients ≥75 years
  • Study drug discontinued for adverse events in 7.2% on prasugrel vs 6.3% on clopidogrel

Monitoring

  • There is no routine laboratory monitoring requirement in the fetched SPC sections
  • monitoring is clinical and bleeding-focused. §4.4: use 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 applies especially to patients ≥75 years, those with a propensity to bleed (recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, active peptic ulcer disease), body weight <60 kg, and those on medicines that increase bleeding risk (oral anticoagulants, clopidogrel, NSAIDs, fibrinolytics).
  • Counsel patients 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.' For active bleeding needing reversal, 'platelet transfusion may be appropriate.' Timing of loading in NSTEMI (ACCOAST): a loading dose given on average 4 hours before angiography increased major and minor peri-procedural bleeding versus loading at the time of PCI.

Clinical monograph

How it works

It is a thienopyridine prodrug that is metabolised to an active metabolite which irreversibly blocks the platelet P2Y12 ADP receptor, inhibiting platelet aggregation.

Prescribing in practice

  • Contraindicated after prior stroke or transient ischaemic attack because of an unacceptable intracranial bleeding risk, and it is generally avoided in low body weight and the elderly where bleeding risk is higher.
  • It increases the risk of major bleeding, so it must be stopped an appropriate interval before surgery such as coronary bypass grafting.
  • Active pathological bleeding and severe hepatic impairment are contraindications, and it is used with aspirin as part of dual antiplatelet therapy.

Monitoring

Monitor for signs of bleeding and bruising, with no routine platelet-function testing required in normal practice.

Counselling the patient

  • Do not stop taking it without medical advice, as this raises the risk of stent thrombosis.
  • Report unusual bleeding or bruising and tell any dentist or surgeon you take this medicine.

Evidence & guidelines

The TRITON-TIMI 38 trial supported prasugrel with aspirin in acute coronary syndrome managed by PCI, and it is recommended in NICE and ESC guidance.

Reference: TRITON-TIMI 38 (Wiviott et al. NEJM 2007); NICE TA317 (Prasugrel in ACS); ESC ACS NSTEMI Guidelines 2023; MHRA SPC Efient; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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