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Pharmaceutical Facts on Eliquis Tablets
| Category | Details |
|---|---|
| Generic Name | Apixaban |
| Brand Name | Eliquis |
| Drug Class | Anticoagulant (Factor Xa inhibitor) |
| Indication | Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. |
| Other Indications | – Treatment of deep vein thrombosis (DVT) |
| – Treatment of pulmonary embolism (PE) | |
| – Prevention of recurrent DVT and PE | |
| – Prevention of DVT following hip or knee replacement surgery | |
| Formulation | Oral tablet |
| Common Dosages | 2.5 mg, 5 mg |
| Mechanism of Action | Inhibits Factor Xa, an enzyme crucial for the coagulation cascade, reducing thrombin generation and clot formation. |
| Pharmacokinetics | – Absorption: Rapid absorption with peak plasma concentration in 3-4 hours |
| – Half-life: Approximately 12 hours | |
| – Metabolism: Primarily hepatic metabolism via CYP3A4, minor CYP1A2, and others | |
| – Excretion: Mainly renal excretion (27%) and biliary/intestinal (feces) (75%) | |
| Administration | – Can be taken with or without food |
| – Missed dose: Take as soon as remembered on the same day; do not double dose | |
| Common Side Effects | – Bleeding |
| – Anemia | |
| – Nausea | |
| – Bruising | |
| – Elevated liver enzymes | |
| Serious Side Effects | – Major bleeding |
| – Intracranial hemorrhage | |
| – Spinal/epidural hematoma | |
| – Hypersensitivity reactions | |
| – Thrombocytopenia | |
| Contraindications | – Active pathological bleeding |
| – Severe hypersensitivity to Eliquis or its components | |
| – Hepatic disease associated with coagulopathy and clinically relevant bleeding risk | |
| – Patients with prosthetic heart valves | |
| Special Populations | – Elderly: Dose adjustments may be necessary due to increased risk of bleeding |
| – Renal Impairment: Dose adjustment needed for severe impairment | |
| – Hepatic Impairment: Use with caution in mild to moderate impairment; contraindicated in severe impairment | |
| Monitoring | – No routine monitoring of coagulation parameters required |
| – Periodic assessment of renal function | |
| – Monitor for signs and symptoms of bleeding | |
| Pregnancy Category | B (risk not ruled out); use only if the potential benefit justifies the potential risk to the fetus |
| Lactation | It is unknown if Eliquis is excreted in human milk; use with caution or consider discontinuing nursing |
| Drug Interactions | – Strong CYP3A4 inhibitors: Increase the risk of bleeding (e.g., ketoconazole, itraconazole, ritonavir) |
| – Strong CYP3A4 inducers: Decrease effectiveness of Eliquis (e.g., rifampin, phenytoin, carbamazepine) | |
| – Other anticoagulants: Increased risk of bleeding (e.g., warfarin, heparin) | |
| – NSAIDs/Antiplatelets: Increased risk of bleeding | |
| Overdose Management | – Activated charcoal may reduce absorption if administered within hours of ingestion |
| – Supportive care; andexanet alfa as a specific antidote for life-threatening or uncontrolled bleeding | |
| – Dialysis is not expected to be effective due to high protein binding | |
| Special Precautions | – Patients with active cancer: Increased risk of thromboembolism |
| – Surgery/Procedures: Discontinue 48-72 hours prior to elective surgery or invasive procedures | |
| – Avoid in patients with a history of heparin-induced thrombocytopenia (HIT) | |
| – Discontinuation: Increases the risk of thrombotic events | |
| Storage | – Store at room temperature (20-25°C or 68-77°F) |
| – Keep in the original packaging to protect from moisture | |
| – Keep out of reach of children | |
| Manufacturer | Bristol-Myers Squibb and Pfizer |
| Approval Year | 2012 |
| Market Availability | Widely available in the US and internationally |
| Patent Expiry | Expected patent expiry in the US is 2026 |