July 31, 2015
Recommended Topic Related To:

Eliquis

"The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart v"...

Eliquis




Indications
Dosage
How Supplied

INDICATIONS

Reduction Of Risk Of Stroke And Systemic Embolism In Nonvalvular Atrial Fibrillation

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

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.

Treatment Of Deep Vein Thrombosis

ELIQUIS is indicated for the treatment of DVT.

Treatment Of Pulmonary Embolism

ELIQUIS is indicated for the treatment of PE.

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.

DOSAGE AND ADMINISTRATION

Recommended Dose

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.

The recommended dose of ELIQUIS is 2.5 mg twice daily in patients with at least two of the following characteristics:

  • age ≥ 80 years
  • body weight ≤ 60 kg
  • serum creatinine ≥ 1.5 mg/dL
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.
Treatment of DVT and PE

The recommended dose of ELIQUIS is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily.

Reduction in the Risk of Recurrence of DVT and PE

The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies].

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.

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. One approach is to 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 From Eliquis To Anticoagulants Other Than Arfarin (Oral Or Parenteral)

Discontinue ELIQUIS and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of ELIQUIS.

Switching From Anticoagulants Other Than Warfarin (Oral Or Parenteral) to ELIQUIS

Discontinue the anticoagulant other than warfarin and begin taking ELIQUIS at the usual time of the next dose of the anticoagulant other than warfarin.

Strong Dual Inhibitors Of CYP3A4 And P-glycoprotein

For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose by 50% 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) [see CLINICAL PHARMACOLOGY].

In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp [see DRUG INTERACTIONS].

Administration Options

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.

HOW SUPPLIED

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 “2%” on the other side Bottles of 60 0003-0893-21
Bottles of 180 0003-0893-41
Hospital Unit-Dose Blister Package of 100 0003-0893-31
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 Package of 100 0003-0894-31

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 June 2015

Last reviewed on RxList: 7/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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