prasugrel besilate: clinical use

Prescribing considerations

• Confirm that the indication involves acute coronary syndrome managed with primary or delayed PCI and concomitant aspirin.
• Balance ischaemic benefit against bleeding risk, particularly with older age, low body weight, renal or moderate hepatic impairment, recent trauma or surgery, gastrointestinal bleeding, peptic ulceration or other haemostasis-altering treatments.
• Premature interruption after PCI may increase thrombosis, myocardial infarction and mortality risk; coordinate any proposed interruption with cardiology.
• Establish procedure plans and coronary anatomy where urgent bypass surgery may be possible.
• Be alert to previous hypersensitivity to clopidogrel or another thienopyridine.

Contraindications and cautions

• Active pathological bleeding
• Previous stroke or transient ischaemic attack
• Severe hepatic impairment
• Hypersensitivity to prasugrel or a formulation excipient

Monitoring

• Assess clinically for unusual, prolonged, gastrointestinal, urinary, puncture-site or intracranial bleeding.
• Review for anaemia, thrombocytopenia and symptoms suggesting TTP.
• Monitor for hypersensitivity, including angioedema.
• Reassess bleeding risk when starting anticoagulants, NSAIDs, other antiplatelets or fibrinolytics and around invasive procedures.

Clinical pharmacology

Prasugrel is a rapidly activated prodrug. Its active metabolite irreversibly inhibits platelet P2Y12 ADP receptors; metabolism involves mainly CYP3A4 and CYP2B6, with lesser contributions from CYP2C9 and CYP2C19.

Formulation and product differences

• The selected product is a beige, capsule-shaped, film-coated tablet marked “PH4” and “M”.
• The selected formulation contains sunset yellow FCF aluminium lake, which may cause allergic reactions.
• The tablet should not be crushed or broken and should remain in its original packaging to protect it from moisture.

Tablet

Route: Oral

Strengths: 10 mg