Prasugrel is indicated to lower the risk of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are undergoing management with percutaneous coronary intervention (PCI), including:
Prasugrel is a thienopyridine class antiplatelet agent and a prodrug that irreversibly inhibits the P2Y12 ADP receptor on platelets. Its active metabolite blocks the binding of adenosine diphosphate (ADP) to platelet receptors, thereby inhibiting ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. This results in reduced platelet aggregation. The mechanism of action of Prasugrel is comparable to that of clopidogrel.
Adults: Prasugrel should be initiated with a single 60mg loading dose and then continued at 10 mg once a day. Patients taking Prasugrel 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, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’s underlying disease. A treatment of up to 12 months is recommended, unless the discontinuation of Prasugrel is clinically indicated.
Patients ≥75 years old: The use of Prasugrel 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 60mg loading dose a reduced maintenance dose of 5 mg should be prescribed. Patients ≥75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel.
Patients weighing <60 kg: Prasugrel should be given as a single 60mg loading dose and then continued at a 5mg once-daily dose. The 10mg 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 10mg once-daily dose, compared with patients <60 kg.
Renal impairment: No dose adjustment is necessary for patients with renal impairment, including patients with end-stage renal disease.
Hepatic impairment: 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.
Children and adolescents: Prasugrel is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Warfarin: Concomitant use of Prasugrel with warfarin increases the likelihood of bleeding.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Long-term combined use of Prasugrel and NSAIDs may elevate bleeding risk.
Other Concomitant Medications: Prasugrel may be coadministered with drugs that either induce or inhibit cytochrome P450 enzymes. It can also be used alongside aspirin (75–325 mg/day), heparin, GP IIb/IIIa inhibitors, statins, digoxin, and agents that increase gastric pH such as proton pump inhibitors and H2 receptor antagonists.
Prasugrel is contraindicated in patients with hypersensitivity to the drug or its components, active pathological bleeding, history of stroke or transient ischemic attack (TIA), and severe hepatic impairment (Child-Pugh class C).
Common: Anaemia, haematoma, epistaxis, gastrointestinal bleeding, rash, ecchymosis, haematuria, hematoma at vascular puncture site, bleeding at puncture site, contusion.
Uncommon: Hypersensitivity reactions including angioedema, ocular bleeding, hemoptysis, retroperitoneal hemorrhage, rectal bleeding, hematochezia, gingival bleeding, and post-procedural bleeding.
Rare: Thrombocytopenia and subcutaneous hematoma.
There are no well-controlled studies on the use of Prasugrel in pregnant women. Animal studies have not shown fetal harm, but these findings may not fully predict human response. It is not known whether Prasugrel is excreted in human breast milk. Therefore, it should be used during breastfeeding only if the potential benefit outweighs the possible risk to the infant.
Bleeding Risk: Patients with a higher risk of bleeding (e.g., anemia, thrombocytopenia, history of bleeding disorders) should receive Prasugrel only after careful benefit-risk evaluation. Increased bleeding risk has been observed in ACS patients treated with Prasugrel and aspirin. This includes elderly patients (≥75 years), individuals with low body weight (<60 kg), and those with recent trauma, surgery, gastrointestinal bleeding, or active peptic ulcer disease. Lower maintenance doses (5 mg) are recommended in low body weight patients.
Surgery: Patients should inform healthcare providers about Prasugrel use before surgery or dental procedures. If elective surgery is planned, Prasugrel should be discontinued at least 7 days prior. Increased bleeding risk has been observed in patients undergoing CABG within 7 days of discontinuation.
Overdose of Prasugrel may result in prolonged bleeding time and bleeding complications. There is no specific antidote. In cases of significant bleeding, platelet transfusion or other blood products may be considered.
Antiplatelet agent.
Store in a cool, dry place away from light and heat. Keep out of reach of children.
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