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FDA approved Eliquis (apixaban) for Reducing Stroke Risk in Nonvalvular Atrial FibrillationFDA approved Eliquis to prevent strokes and treat blood clots.

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Key Takeaway
Consider Eliquis for stroke prevention in nonvalvular AF and for DVT/PE management, with dose adjustments for age, weight, and renal function.

The FDA has approved Eliquis (apixaban), a factor Xa inhibitor, for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is also indicated for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery, treatment of DVT and pulmonary embolism (PE), and reduction in the risk of recurrent DVT and PE after initial therapy. This approval provides clinicians with an oral anticoagulant option that does not require routine monitoring of coagulation parameters. The recommended dosing varies by indication, with dose adjustments for certain patient characteristics such as age, weight, and renal function. Eliquis offers a predictable pharmacokinetic profile and is administered twice daily without the need for dietary restrictions.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Eliquis (apixaban) is a factor Xa inhibitor. It inhibits factor Xa, thereby decreasing thrombin generation and thrombus formation.

Indication & Patient Population

Eliquis is indicated for: reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery; treatment of DVT and PE; and reduction in the risk of recurrent DVT and PE following initial therapy.

Dosing & Administration

For nonvalvular atrial fibrillation: 5 mg orally twice daily. Reduce to 2.5 mg twice daily in patients with at least two of: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL. For DVT prophylaxis after hip/knee replacement: 2.5 mg twice daily, starting 12-24 hours after surgery. Duration: 35 days for hip replacement, 12 days for knee replacement. For treatment of DVT/PE: 10 mg twice daily for 7 days, then 5 mg twice daily. For reduction of recurrent DVT/PE: 2.5 mg twice daily after at least 6 months of treatment. Missed dose: take as soon as possible, do not double. Temporary interruption: discontinue at least 48 hours before surgery with moderate/high bleeding risk, at least 24 hours before low-risk procedures. Restart after hemostasis. Converting from warfarin: start Eliquis when INR <2.0. Converting to warfarin: discontinue Eliquis and begin parenteral anticoagulant and warfarin at next dose time. For combined P-gp and strong CYP3A4 inhibitors: reduce dose by 50% for patients on 5 mg or 10 mg twice daily; avoid coadministration with 2.5 mg twice daily.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Eliquis provides an oral anticoagulant option for multiple indications with fixed dosing and no routine monitoring. Dose adjustments are needed for certain patient populations and drug interactions.

The FDA has approved Eliquis (apixaban) to help prevent strokes in patients with a common heart rhythm problem called atrial fibrillation. It is also approved to treat and prevent dangerous blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism). This includes prevention after hip or knee replacement surgery.

Eliquis is a type of blood thinner that works by blocking a clotting factor in the blood. Unlike the older drug warfarin, Eliquis does not require regular blood tests to check its effect. It is taken twice a day and has no food restrictions.

The approval gives doctors and patients another option for managing clot risks. However, like all blood thinners, Eliquis increases the risk of bleeding. The dose may need to be adjusted for older adults, people with kidney problems, or those with low body weight.

If you are prescribed Eliquis, talk to your doctor about how it fits your health needs. Do not stop or start any blood thinner without medical guidance. This approval is a step forward, but your doctor can help decide if Eliquis is right for you.

What this means for you:
Eliquis is a new blood thinner pill that does not require regular blood monitoring.

Study Details

Study typeFda approval
PublishedDec 2012
View Original Abstract ↓
1 INDICATIONS AND USAGE ELIQUIS is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3 , 1.4 , 1.5) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. 1.3 Treatment of Deep Vein Thrombosis ELIQUIS is indicated for the treatment of DVT. 1.4 Treatment of Pulmonary Embolism ELIQUIS is indicated for the treatment of PE. 1.5 Reduction in the Risk of Recurrence of DVT and PE ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy.
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