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Reduction Of Risk Of Stroke And Systemic Embolism In Nonvalvular Atrial Fibrillation
Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery
DOSAGE AND ADMINISTRATION
Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation
The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery
The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
- In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days.
- In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days.
In patients with nonvalvular atrial fibrillation
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
Coadministration with CYP3A4 and P-gp inhibitors
For patients receiving ELIQUIS 5 mg twice daily 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.
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.
Temporary Interruption 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. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
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 initial INR measurements during the transition to 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.
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].
The dosing adjustment for moderate renal impairment is described above. The recommended dose for nonvalvular atrial fibrillation patients with end-stage renal disease (ESRD) maintained on hemodialysis is 5 mg twice daily. Reduce dose to 2.5 mg twice daily if one of the following patient characteristics (age ≥ 80 years or body weight ≤ 60 kg) is present [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
For patients who are unable to swallow whole tablets, 5 mg and 2.5 mg ELIQUIS tablets may be crushed and suspended in 60 mL D5W and immediately delivered through a nasogastric tube (NGT) [see CLINICAL PHARMACOLOGY]. Information regarding the administration of crushed and suspended ELIQUIS tablets swallowed by mouth is not available.
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.
|Tablet Strength||Tablet Color/Shape||Tablet Markings||Package Size||NDC Code|
|2.5 mg||Yellow, round, biconvex||Debossed with “893” on one side and “2½” on the other side||Bottles of 60||0003-0893-21|
|Bottles of 180||0003-0893-41|
|Hospital Unit-Dose Blister||0003-0893-31|
|Package of 100|
|5 mg||Pink, oval, biconvex||Debossed with “894” on one side and “5” on the other side||Bottles of 60||0003-0894-21|
|Bottles of 180||0003-0894-41|
|Hospital Unit-Dose Blister||0003-0894-31|
|Package of 100|
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. Revised March 2014
Last reviewed on RxList: 4/7/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Eliquis Information
Report Problems to the Food and Drug Administration
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