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prasugrel (Rx)Brand and Other Names:Effient

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg
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Acute Coronary Syndrome

Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with 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 PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day; if patient <60 kg, consider 5 mg/day PO because of potentially increased bleeding risk (efficacy and safety not established)

Dosing Modifications

Renal impairment

  • Dose adjustment not necessary

Hepatic impairment

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

Sickle Cell Disease (Orphan)

Orphan designation for treatment of sickle cell disease

Sponsor

  • Eli Lilly; Lilly Corporate Center; Indianapolis, IN 46285

Not recommended

Acute Coronary Syndrome

<75 years

60 mg PO once as loading dose, then 10 mg/day PO in combination with aspirin 81-325 mg/day

Weight <60 kg: consider 5 mg/day because of potentially increased bleeding risk (efficacy and safety not established)

≥75 years

Generally not recommended, because of increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients (diabetes or prior MI), for whom effect appears to be greater and use may be considered

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Interactions

Interaction Checker

prasugrel and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Bleeding

            Anemia

            Atrial fibrillation

            Back pain

            Bradycardia

            Dizziness

            Dyspnea

            Headache

            Hypertension

            Nausea

            <1%

            Thrombotic thrombocytopenic purpura

            Abnormal hepatic function

            Angioedema

            Hematoma

            Hemolysis

            Hemorrhage

            Abnormal liver function

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            Warnings

            Black Box 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 >75 years (increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk patients [diabetes or prior MI])
            • 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 first few weeks after ACS)

            Additional risk factors for bleeding

            • Weight <60 kg
            • Propensity to bleed (eg, recent trauma, recent surgery, recent or recurrent GI bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate-to-severe renal impairment)
            • Concomitant use of other drugs that increase bleeding risk

            Contraindications

            Hypersensitivity

            Active pathologic bleeding (eg, peptic ulcer, intracranial hemorrhage)

            Prior TIA or stroke

            Cautions

            Hypersensitivity with angioedema 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 fibrinolytics

            Bleeding may increase in patients <60 kg

            See Black Box Warnings

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Not known if drug excreted in breast milk; discontinue, or do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Prasugrel is a prodrug, a thienopyridine that inhibits platelet activation and aggregation through irreversible binding of active metabolite to adenosine phosphate (ADP) platelet receptors (specifically, P2Y12 receptor)

            Absorption

            Bioavailability: >78%

            Peak plasma time: 30 min

            Absorption: >79%

            Distribution

            Protein bound: Active metabolite, 98%

            Vd: 44-48 L

            Metabolism

            Rapidly hydrolyzed in intestine to active metabolite via CYP3A4 and CYP2B6

            Elimination

            Half-life: 7 hr (range, 2-15 hr)

            Clearance: 112-166 L/hr

            Excretion: Urine (68%), feces (27%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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