Prasugrel

PRASUGREL- prasugrel hydrochloride tablet, film coated
Golden State Medical Supply, Inc.

WARNING: BLEEDING RISK

  • Prasugrel tablets can cause significant, sometimes fatal, bleeding [see Warnings and Precautions ( 5.1, 5.2) and Adverse Reactions ( 6.1)].
  • Do not use Prasugrel tablets in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications ( 4.1, 4.2)].
  • In patients75 years of age, Prasugrel tablets is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered [see Use in Specific Populations ( 8.5)].
  • Do not start Prasugrel tablets in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Prasugrel tablets at least 7 days prior to any surgery. [see Warnings and Precautions ( 5.2)].
  • Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions ( 5.1)].
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Prasugrel tablets [see Warnings and Precautions ( 5.1)].
  • If possible, manage bleeding without discontinuing Prasugrel tablets. Discontinuing Prasugrel tablets, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events [see Warnings and Precautions ( 5.3)]

1 INDICATIONS AND USAGE

1.1 Acute Coronary Syndrome

Prasugrel tablet is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:

  • Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
  • Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.

Prasugrel tablet has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies ( 14)] .

2 DOSAGE AND ADMINISTRATION

Initiate Prasugrel tablets treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Prasugrel tablets should also take aspirin (75-mg to 325-mg) daily [see Drug Interactions ( 7.4) and Clinical Pharmacology ( 12.3)] . Prasugrel tablets may be administered with or without food [see Clinical Pharmacology ( 12.3) and Clinical Studies ( 14)] .

Timing of Loading Dose

In the clinical trial that established the efficacy and safety of Prasugrel tablets, the loading dose of Prasugrel tablets was not administered until coronary anatomy was established in UA/NSTEMI patients and in STEMI patients presenting more than 12 hours after symptom onset. In STEMI patients presenting within 12 hours of symptom onset, the loading dose of Prasugrel tablets was administered at the time of diagnosis, although most received Prasugrel tablets at the time of PCI [see Clinical Studies ( 14)] . For the small fraction of patients that required urgent CABG after treatment with Prasugrel tablets, the risk of significant bleeding was substantial.

Although it is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation, in a trial of 4033 NSTEMI patients, no clear benefit was observed when Prasugrel tablets loading dose was administered prior to diagnostic coronary angiography compared to at the time of PCI; however, risk of bleeding was increased with early administration in patients undergoing PCI or early CABG.

Dosing in Low Weight Patients

Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10-mg once daily maintenance dose. 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 [see Warnings and Precautions ( 5.1), Adverse Reactions ( 6.1), and Clinical Pharmacology ( 12.3)].

3 DOSAGE FORMS AND STRENGTHS

Prasugrel tablets 5-mg is available as a yellow, round, biconvex, film-coated, non-scored tablet debossed with “P” on one side and “5” on the other side.

Prasugrel tablets 10-mg is available as a beige, round, biconvex, film-coated, non-scored tablet; debossed with “P” on one side and “10” on the other side.

4 CONTRAINDICATIONS

4.1 Active Bleeding

Prasugrel tablet is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions ( 6.1)] .

4.2 Prior Transient Ischemic Attack or Stroke

Prasugrel tablet is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 ( TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibitio N with Prasugrel), patients with a history of TIA or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on Prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Prasugrel tablets and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from TRITON-TIMI 38. Patients who experience a stroke or TIA while on Prasugrel tablets generally should have therapy discontinued [see Adverse Reactions ( 6.1) and Clinical Studies ( 14)].

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