pra-soo-GREL

• Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI) including patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI).
• Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with ST-elevation myocardial infarction (STEMI) when managed with either primary/delayed PCI.

• Acts by irreversibly binding its active metabolite to the P2Y₁₂ class of ADP receptors on platelets; inhibiting platelet activation and aggregation.

• Decreased thrombotic events including cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke.

Absorption: Well absorbed following oral administration (79%), then rapidly converted to an active metabolite.

Distribution: Unknown.

Protein Binding: Active metabolite — 98%.

Metabolism/Excretion: Active metabolite is metabolized to two inactive compounds; 68% excreted in the urine and 27% in feces as inactive metabolites.

Half-life: Active metabolite — 7 hr (range 2–15 hr).

Contraindicated in:

• Hypersensitivity
• Active pathological bleeding
• History of transient ischemic attack or stroke.

Use Cautiously in:

• Patients about to undergo coronary artery bypass grafting (CABG) (↑ risk of bleeding; discontinue at least 7 days prior to surgery)
• Premature discontinuation (↑ risk of stent thrombosis, MI, and death)
• Body weight <60 kg, propensity to bleed, severe hepatic impairment, concurrent use of medications that ↑ the risk of bleeding (↑ risk of bleeding)
• Hypotension in the setting of recent coronary angiography, PCI, CABG, or other surgical procedure (suspect bleeding but do not discontinue prasugrel)
• Geri: Use in patients 75 yr of age generally not recommended (↑ risk of fatal/intracranial bleeding and questionable benefit, except in high-risk patients such as diabetes or prior MI)
• OB: Use only if potential benefit to mother justifies potential risk to fetus
• Lactation: Use only if potential benefit to the mother justifies potential risk to nursing infant
• Pedi: Safety and effectiveness not established.

Neuro: dizziness, fatigue, headache.

Resp: cough, dyspnea.

CV: atrial fibrillation, bradycardia, hypertension, hypotension, peripheral edema.

GI: diarrhea, nausea.

Derm: rash.

Hemat: BLEEDING, THROMBOTIC THROMBOCYTOPENIC PURPURA, leukopenia.

Metab: hyperlipidemia.

MS: back pain, extremity pain.

Misc: ALLERGIC REACTIONS INCLUDING ANGIOEDEMA, fever, non-cardiac chest pain.

Drug-Drug:

• ↑risk of bleeding with warfarin and NSAIDs.
• Opioids may ↓ absorption of active metabolite and ↓ antiplatelet effects; consider using parenteral antiplatelet in patients with acute coronary syndrome if concurrent use of opioids needed.

• PO (Adults 60 kg): 60 mg initially as a loading dose, then 10 mg once daily.
• PO (Adults <60 kg): Consider maintenance dose of 5 mg once daily.

• Discontinue prasugrel 7 days before planned surgical procedures.
  • Patients should take aspirin 75–325 mg daily with prasugrel.
  • In patients with unstable angina (UA) or NSTEMI, dose is usually administered at time of diagnosis or at time of PCI.
  • In patients with STEMI presenting within 12 hrs of symptom onset, loading dose is usually administered at time of diagnosis or at time of PCI.
• PO: Administer once daily without regard to food. Swallow tablets whole; do not break.

Effient

Therapeutic Classification: antiplatelet agents

Pharmacologic Classification:

(Generic available)

• Tablets: 5 mg; 10 mg;

(effect on platelet function)

†Following discontinuation.

• Assess patient for symptoms of stroke, peripheral vascular disease, or MI periodically during therapy.
• Monitor patient for signs of thrombotic thrombocytopenic purpura (thrombocytopenia, microangiopathic hemolytic anemia, neurologic findings, renal dysfunction, fever). May rarely occur, even after short exposure (<2 wk). Requires prompt treatment.

• Monitor bleeding time during therapy. Prolonged bleeding time, which is time- and dose-dependent, is expected.
  • Monitor CBC with differential and platelet count periodically during therapy. Thrombocytopenia and anemia may rarely occur.

• Risk for injury (Indications, Side Effects).

• Instruct patient to take medication as directed. Take missed doses as soon as possible unless almost time for next dose; do not double doses. Do not discontinue without consulting health care professional. Advise patient to read Medication Guide before taking and with each Rx refill; in case of changes. Instruct patient to keep prasugrel in original container with dessicant, and keep tightly capped to protect from moisture.
• Advise patient to notify health care professional promptly if fever, weakness, skin paleness, purple skin patches, yellowing of skin or eyes, chills, sore throat, neurological changes, or unusual bleeding or bruising, swelling of lips, difficulty breathing, rash, or hives occurs.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially NSAIDs.
• Advise female patient to notify health care professional if pregnancy is planned or suspected and to avoid breast feeding during therapy.

• Prevention of stroke, MI, and vascular death in patients at risk.

NDC Code^*

• 0002- Eli Lilly and Company
  • 0002-5121- Effient
    • 0002-5121-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-5121-30)

• 0002- Eli Lilly and Company
  • 0002-5121- Effient
    • 0002-5121-52- 24 BLISTER PACK in 1 CARTON (0002-5121-52) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5121-01)

• 0002- Eli Lilly and Company
  • 0002-5123- Effient
    • 0002-5123-30- 30 TABLET, FILM COATED in 1 BOTTLE (0002-5123-30)

• 0002- Eli Lilly and Company
  • 0002-5123- Effient
    • 0002-5123-77- 90 BLISTER PACK in 1 CARTON (0002-5123-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5123-01)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-5185- Prasugrel
    • 0378-5185-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-5186- Prasugrel
    • 0378-5186-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)

• 0440- Liberty Pharmaceuticals, Inc.
  • 0440-0604- PRASUGREL
    • 0440-0604-30- 30 TABLET, FILM COATED in 1 BOTTLE (0440-0604-30)

• 0440- Liberty Pharmaceuticals, Inc.
  • 0440-0605- PRASUGREL
    • 0440-0605-30- 30 TABLET, FILM COATED in 1 BOTTLE (0440-0605-30)

• 16729- Accord Healthcare Inc.
  • 16729-272- Prasugrel
    • 16729-272-10- 30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)

• 16729- Accord Healthcare Inc.
  • 16729-273- Prasugrel
    • 16729-273-10- 30 TABLET, FILM COATED in 1 BOTTLE (16729-273-10)

• 43817- Panacea Biotec Ltd.
  • 43817-239- Prasugrel
    • 43817-239-01- 30 TABLET, FILM COATED in 1 BOTTLE (43817-239-01)

• 43817- Panacea Biotec Ltd.
  • 43817-240- Prasugrel
    • 43817-240-01- 30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01)

• 48792- Sunshine Lake Pharma Co., Ltd.
  • 48792-7821- prasugrel
    • 48792-7821-1- 30 TABLET, FILM COATED in 1 BOTTLE (48792-7821-1)

• 48792- Sunshine Lake Pharma Co., Ltd.
  • 48792-7822- prasugrel
    • 48792-7822-1- 30 TABLET, FILM COATED in 1 BOTTLE (48792-7822-1)

• 50090- A-S Medication Solutions
  • 50090-4118- Prasugrel
    • 50090-4118-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-4118-0)

• 60505- Apotex Corp.
  • 60505-4642- Prasugrel
    • 60505-4642-3- 30 TABLET, FILM COATED in 1 BOTTLE (60505-4642-3)

• 60505- Apotex Corp.
  • 60505-4643- Prasugrel
    • 60505-4643-3- 30 TABLET, FILM COATED in 1 BOTTLE (60505-4643-3)

• 60687- American Health Packaging
  • 60687-412- Prasugrel
    • 60687-412-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-412-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-412-11)

• 65162- Amneal Pharmaceuticals LLC
  • 65162-001- Prasugrel
    • 65162-001-03- 30 TABLET, FILM COATED in 1 BOTTLE (65162-001-03)

• 65162- Amneal Pharmaceuticals LLC
  • 65162-002- Prasugrel
    • 65162-002-03- 30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)

• 65862- Aurobindo Pharma Limited
  • 65862-829- Prasugrel
    • 65862-829-03- 3 BLISTER PACK in 1 CARTON (65862-829-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10)

• 65862- Aurobindo Pharma Limited
  • 65862-829- Prasugrel
    • 65862-829-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30)

• 65862- Aurobindo Pharma Limited
  • 65862-830- Prasugrel
    • 65862-830-03- 3 BLISTER PACK in 1 CARTON (65862-830-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-830-10)

• 65862- Aurobindo Pharma Limited
  • 65862-830- Prasugrel
    • 65862-830-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-830-30)

• 67877- Ascend Laboratories, LLC
  • 67877-604- PRASUGREL
    • 67877-604-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-604-30)

• 67877- Ascend Laboratories, LLC
  • 67877-605- PRASUGREL
    • 67877-605-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-605-30)