ELIQUIS® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Recommended Dose

The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.

Dosage Adjustments

The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with any 2 of the following characteristics:

• age ≥ 80 years
• body weight ≤ 60 kg
• serum creatinine ≥ 1.5 mg/dL

CYP3A4 and P-gp inhibitors

When ELIQUIS is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin), the recommended dose is 2.5 mg twice daily [see CLINICAL PHARMACOLOGY].

In patients already taking 2.5 mg twice daily, coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp should be avoided.

Missed Dose

If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions

ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Converting from or to ELIQUIS

Switching from warfarin to ELIQUIS

Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.

Switching from ELIQUIS to warfarin

ELIQUIS affects INR, so that INR measurements during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between ELIQUIS and anticoagulants other than warfarin

Discontinue one being taken and begin the other at the next scheduled dose.

Hepatic Impairment

No dose adjustment is required in patients with mild hepatic impairment.

Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided [see CLINICAL PHARMACOLOGY].

ELIQUIS is not recommended in patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY].

Renal Impairment

The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance < 15 mL/min or on dialysis.

Dosage Forms And Strengths

• 2.5 mg, yellow, round, biconvex, film-coated tablets with “893” debossed on one side and “2½” on the other side.
• 5 mg, pink, oval-shaped, biconvex, film-coated tablets with “894” debossed on one side and “5” on the other side.

ELIQUIS (apixaban) tablets are available as listed in the table below.

Storage and Handling

Store at 20°C to 25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F-86°F) [see USP Controlled Room Temperature].

Manufactured by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA. Marketed by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA and Pfizer Inc New York, New York 10017 USA. Issued December 2012

Last reviewed on RxList: 1/10/2013
This monograph has been modified to include the generic and brand name in many instances.