Prasugrel

Prasugrel is an antiplatelet drug that prevents the platelets in the bloodstream from aggregating and forming blood clots, used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.

• Prasugrel is available under the following different brand names: Effient.

Tablet

• 5 mg
• 10 mg

Dosage Considerations – Should be Given as Follows:

Acute Coronary Syndrome

• Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with the acute coronary syndrome (ACS) managed by means of percutaneous coronary intervention (PCI) who have either (a) unstable angina or non-ST-elevation MI (NSTEMI) or (b) ST-elevation MI (STEMI) when managed with primary or delayed PCI
• 60 mg orally once as a loading dose, then 10 mg/day orally in combination with aspirin 81-325 mg/day; if patient less than 60 kg, consider 5 mg/day orally because of potentially increased bleeding risk (efficacy and safety not established)
• Geriatric, under 75 years:
  • 60 mg orally once as a loading dose, then 10 mg/day orally in combination with aspirin 81-325 mg/day
  • Weightless than 60 kg: consider 5 mg/day because of potentially increased bleeding risk (efficacy and safety not established)
  • Geriatric, 75 years and older: Generally not recommended, because of increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients (diabetes or prior heart attack [myocardial infarction]), for whom effect appears to be greater and use may be considered

Dosing Modifications

Renal impairment

• Dose adjustment is not necessary

Hepatic impairment

• Mild-to-moderate: Dose adjustment not necessary
• Severe: Not studied

Pediatric

• Not recommended

Common side effects of Prasugrel include:

• Bleeding
• Anemia
• Atrial fibrillation
• Back pain
• Slow heart rate
• Dizziness
• Shortness of breath
• Headache
• High or low blood pressure (hypertension or hypotension)
• Nausea
• Minor chest pain
• Tired feeling
• Fatigue
• Cough
• Rash
• Fever
• Swelling or pain in the extremities
• Diarrhea

Less common side effects of prasugrel include:

• Thrombotic thrombocytopenic purpura
• Skin swelling
• Hematoma
• Hemolysis
• Bleeding (hemorrhage)
• Abnormal liver function

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Prasugrel has no known severe interactions with other drugs.
  • antithrombin alfa
  • antithrombin III
  • apixaban
  • argatroban
  • aspirin rectal
  • bivalirudin
  • cangrelor
  • dalteparin
  • enoxaparin
  • fondaparinux
  • heparin
  • lepirudin
  • protamine
  • tinzaparin
  • warfarin
• Prasugrel has moderate interactions with at least 22 different drugs.
• Mild interactions of prasugrel include:
  • devil's claw
  • ginger
  • ginkgo biloba
  • horse chestnut seed
  • verteporfin

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

Potential for significant, sometimes fatal, bleeding

• Do not use in patients with active bleeding or a history of transient ischemic attack (TIA) or stroke
• Generally not recommended for age over 75 years (increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients [diabetes or prior heart attack/myocardial infarction])
• Do not initiate in patients undergoing urgent coronary artery bypass grafting (CABG); if possible, discontinue at least 7 days before any surgical procedure
• If possible, manage bleeding without discontinuing (risk of subsequent cardiovascular events is increased if prasugrel stopped, particularly in the first few weeks after ACS)
• Additional risk factors for bleeding
  • Weight under 60 kg
  • Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate-to-severe renal impairment)
  • Concomitant use of other drugs that increase bleeding risk

This medication contains prasugrel. Do not take Effient if you are allergic to prasugrel or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Active pathologic bleeding (e.g., peptic ulcer, intracranial hemorrhage)
• Prior transient ischemic attack (TIA) or stroke

Effects of Drug Abuse

• Translation content

Short-Term Effects

• See "What Are Side Effects Associated with Using Prasugrel?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Prasugrel?"

Cautions

• Hypersensitivity with angioedema was reported.
• Bleeding diathesis.
• Thrombocytopenic purpura occurring within 2 weeks of initiation of therapy reported.
• Use caution in severe hepatic impairment and end-stage renal disease.
• Use caution in patients taking anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or fibrinolytic.
• Bleeding may increase in patients under 60 kg.
• See Warnings.

Pregnancy and Lactation

• Due to the mechanism of action and associated identified risk of bleeding, consider the benefits and risks of therapy and possible risks to a fetus when prescribing prasugrel to a pregnant woman. Consult your doctor.
• There is no information regarding the presence of prasugrel in human milk, the effects on a breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from prasugrel or from the underlying maternal condition.