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ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial therapy.
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.
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Dosing for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), after hip or knee replacement surgery
ELIQUIS dosing in hip/knee replacement
Recommended dose for patients undergoing hip replacement surgery1:
2.5 mg twice daily for 35 days
The initial dose should be taken 12 to 24 hours after hip replacement surgery
No international normalized ratio (INR) monitoring
No food restrictions or meal requirements—food does not affect the bioavailability of ELIQUIS
No dose adjustments for patients with renal impairment, including those with end-stage renal disease (ESRD) on dialysis
Clinical efficacy and safety studies with ELIQUIS did not enroll patients with ESRD on dialysis or patients with a creatinine clearance (CrCl) <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-factor Xa activity) data in subjects with ESRD maintained on dialysis.
No special storage requirements
The half-life of ELIQUIS is approximately 12 hours following oral administration
In patients already taking ELIQUIS at a dose of 2.5 mg twice daily: Avoid coadministration with combined P-gp and strong CYP3A4 inhibitors.
Clarithromycin
Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.
See below for additional dosing information, including dose adjustments and important dosing considerations for ELIQUIS.
Recommended dose for patients undergoing knee replacement surgery1:
2.5 mg twice daily for 12 days
The initial dose should be taken 12 to 24 hours after knee replacement surgery
No international normalized ratio (INR) monitoring
No food restrictions or meal requirements—food does not affect the bioavailability of ELIQUIS
No dose adjustments for patients with renal impairment, including those with end-stage renal disease (ESRD) on dialysis
Clinical efficacy and safety studies with ELIQUIS did not enroll patients with ESRD on dialysis or patients with a creatinine clearance (CrCl) <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-factor Xa activity) data in subjects with ESRD maintained on dialysis.
No special storage requirements
The half-life of ELIQUIS is approximately 12 hours following oral administration
In patients already taking ELIQUIS at a dose of 2.5 mg twice daily: Avoid coadministration with combined P-gp and strong CYP3A4 inhibitors.
Clarithromycin
Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.
Drug interactions
| Drug categories/examples2 | Key considerations2 |
|---|---|
Drugs affecting hemostasis
|
Coadministration with these drugs increases the risk of bleeding. |
Combined P-gp and strong CYP3A4 inhibitors
|
Reduce dose by 50%: For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily when coadministered with combined P-gp and strong CYP3A4 inhibitors. In patients already taking ELIQUIS at a dose of 2.5 mg twice daily: Avoid coadministration with combined P-gp and strong CYP3A4 inhibitors. These drugs increase exposure to ELIQUIS and increase the risk of bleeding. |
|
Pharmacokinetic data suggest that no dose adjustment is necessary. |
Combined P-gp and strong CYP3A4 inducers
|
Avoid concomitant use. These drugs decrease exposure to ELIQUIS and increase the risk of stroke and other thromboembolic events. |
- Apixaban is a substrate of both CYP3A4 and P-gp
- Famotidine, atenolol, prasugrel, and enoxaparin did not meaningfully alter the pharmacokinetics of ELIQUIS in healthy subjects
- ELIQUIS did not meaningfully alter the pharmacokinetics of digoxin, naproxen, atenolol, prasugrel, or acetylsalicylic acid in healthy subjects
- APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared with placebo
- For diltiazem, no dose adjustment of ELIQUIS is required53
This chart contains examples of drugs in each of the categories described. These examples reflect those in the ELIQUIS Full Prescribing Information, but do not represent an all-inclusive list.
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.2
Temporary interruption for surgery and other interventions
| Bleeding risk with elective surgery or invasive procedures | Recommendation2 |
|---|---|
| Moderate or high risk of unacceptable or clinically significant bleeding | Discontinue ELIQUIS at least 48 hours prior. |
| Low risk or noncritical site and easily controlled | Discontinue ELIQUIS at least 24 hours prior. |
- 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 surgical or other procedures as soon as adequate hemostasis has been established
Guidance for switching to and from ELIQUIS
| Patients switching from |
Recommendation2 |
|---|---|
| Warfarin to ELIQUIS | Discontinue warfarin and start ELIQUIS when international normalized ratio (INR) is <2.0. |
| 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. |
| ELIQUIS to anticoagulants other than warfarin (oral or parenteral) | Discontinue ELIQUIS and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of ELIQUIS. |
| ELIQUIS to warfarin | ELIQUIS affects INR, so that initial INR measurements during transition to warfarin may not be useful for determining appropriate dose of warfarin. One approach is to discontinue ELIQUIS and begin both 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. |
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 water, 5% dextrose in water (D5W), or apple juice, or mixed with applesauce and promptly administered orally2
- Alternatively, ELIQUIS tablets may be crushed and suspended in 60 mL of water or D5W and promptly delivered through a nasogastric tube2
- Crushed ELIQUIS tablets are stable in water, D5W, apple juice, and applesauce for up to 4 hours2
Dosing in patients with renal or hepatic impairment
Dosing considerations in patients with renal impairment2
Dosing considerations in NVAF patients with renal impairment2
No dose adjustment is recommended for patients with renal impairment, including those with end-stage renal disease (ESRD) on dialysis for the treatment of DVT, PE and reduction in the risk of recurrent DVT and PE following initial therapy
No dose adjustment is recommended for patients with renal impairment, including those with end-stage renal disease (ESRD) on dialysis for prophylaxis of DVT, which may lead to PE, following hip or knee replacement surgery
Clinical efficacy and safety studies with ELIQUIS did not enroll patients with ESRD on dialysis or patients with a creatinine clearance (CrCl) <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic anti-factor Xa (FXa) activity data in subjects with ESRD maintained on dialysis.
ELIQUIS elimination2
Renal excretion accounts for about 27% of total clearance.
ELIQUIS is eliminated in both urine and feces. Biliary and direct intestinal excretion contributes to elimination of ELIQUIS in the feces.
| No dose adjustment for renal impairment alone in patients with NVAF | ||||
|---|---|---|---|---|
 5 mg twice daily
 MILDMODERATESEVEREPatients with end-stage renal disease (ESRD) on dialysis:
|
Reduced dosing for renal impairment plus additional criteria |
2.5 mg twice daily
Recommended dose for:  age≥80 years  body weight≤60 kg  serum creatinine≥1.5 mg/dL |
ELIQUIS elimination |
Renal excretion
accounts for about 27% of total clearance ELIQUIS is eliminated in both urine and feces. Biliary and direct intestinal excretion contributes to elimination of ELIQUIS in the feces 
|
See Drug Interactions above for coadministration with combined P-gp and strong CYP3A4 inhibitors.
Dosing in patients with hepatic impairment
|
MILD
hepatic impairment (Child-Pugh class A) |
No dose adjustment required.2 |
|
MODERATE
hepatic impairment (Child-Pugh class B) |
There is limited clinical experience with ELIQUIS in patients with moderate hepatic impairment; dosing recommendation cannot be provided.2 |
|
SEVERE
hepatic impairment (Child-Pugh class C) |
ELIQUIS is not recommended.2 |
Adjust ELIQUIS dose for patients taking drugs that are combined P-gp and strong CYP3A4 inhibitors.
See Drug Interactions above for more information.
See Drug Interactions above for more information.
ELIQUIS: considerations for reversing the anticoagulant effects2
An agent to reverse the anti-factor Xa activity of ELIQUIS is available
- Please visit www.andexxa.com for more information on availability of a reversal agent
The pharmacodynamic effect of ELIQUIS can be expected to persist for at least 24 hours after the last dose, ie, for about two drug half lives
Additional information for reversal of anticoagulant effect
- Prothrombin complex concentrate (PCC), activated prothrombin concentrate or recombinant factor VIIa may be considered but have not been evaluated in clinical studies
- When PCCs are used, monitoring for the anticoagulation effect of ELIQUIS using a clotting test (PT, INR, or aPTT) or anti-factor Xa (FXa) activity is not useful and is not recommended
- Hemodialysis does not appear to have a substantial impact on ELIQUIS exposure
- Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of ELIQUIS
- There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving ELIQUIS
- There is no experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving ELIQUIS, and they are not expected to be effective as a reversal agent
Activated oral charcoal reduces absorption of ELIQUIS, thereby lowering ELIQUIS plasma concentration
aPTT=activated partial thromboplastin time; INR=international normalized ratio; PT=prothrombin time.
Dosing in patients receiving combined P-gp and strong CYP3A4 inhibitors or combined P-gp and strong CYP3A4 inducers
Combined P-gp and strong CYP3A4 inhibitors
Reduce dose by 50%: For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, when ELIQUIS is coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir).
Clarithromycin
Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.
In patients already taking ELIQUIS at a dose of 2.5 mg twice daily: Avoid coadministration with combined P-gp and strong CYP3A4 inhibitors.
Combined P-gp and strong CYP3A4 Inducers
Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to ELIQUIS and increase the risk of stroke and other thromboembolic events.
References
- ELIQUIS® (apixaban) Package Insert. Bristol-Myers Squibb Company, Princeton, NJ, and Pfizer Inc, New York, NY.
- Data on File. APIX075. Bristol-Myers Squibb Company, Princeton, NJ.
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS® (apixaban), increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- use of indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
- a history of traumatic or repeated epidural or spinal punctures
- a history of spinal deformity or spinal surgery
- optimal timing between the administration of ELIQUIS and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
- Active pathological bleeding
- Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
- Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
- Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
- Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
- Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
- The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). An agent to reverse the anti-factor Xa activity of apixaban is available. Please visit www.andexxa.com for more information on availability of a reversal agent.
- Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours. Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.
- Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
- Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
- Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome (APS): Direct-acting oral anticoagulants (DOACs), including ELIQUIS, are not recommended for use in patients with triple-positive APS. For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
- The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
- 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 noncritical 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.
- Combined P-gp and Strong CYP3A4 Inhibitors: Inhibitors of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with combined P-gp and strong CYP3A4 inhibitors. Clarithromycin Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.
- Combined P-gp and Strong CYP3A4 Inducers: Avoid concomitant use of ELIQUIS with combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban.
- Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
- The limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery, and in the fetus and neonate.
- Labor or delivery: ELIQUIS use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider use of a shorter acting anticoagulant as delivery approaches.
- Breastfeeding is not recommended during treatment with ELIQUIS.
FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
- Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including ELIQUIS should be assessed in these patients and those with abnormal uterine bleeding.
ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
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.
ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.
Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and MEDICATION GUIDE.
ELIQUIS is available in 2.5 mg and 5 mg tablets.
ELIQUIS® and the ELIQUIS logo are trademarks of Bristol-Myers Squibb Company.
All other trademarks are the property of their respective owners.
© 2024 Bristol-Myers Squibb Company. 432-US-2400137 08/24
