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Discover data, tools, and resources for an Rx anticoagulant option
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Discover data, tools, and resources for an Rx anticoagulant option



 

Important Safety Information   View the Web version here U.S. FULL PRESCRIBING
INFORMATION, including Boxed WARNINGS 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.



 

Important Safety Information View the Web version here U.S. FULL PRESCRIBING
INFORMATION, including Boxed WARNINGS

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.

SELECT IMPORTANT SAFETY INFORMATION WARNING: (A) PREMATURE DISCONTINUATION OF
ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (A) Premature discontinuation of
any oral anticoagulant, including ELIQUIS, 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. Please see additional Important Safety Information
continued below.

Access the ELIQUIS Hospital Hub A destination designed to help support you and
your staff, with information and resources for patients prescribed ELIQUIS
Review select clinical and real-world evidence data
for treatment of VTE

 

Access dosing information

 

Download tools related to discharge

 

Access patient resources VTE=venous thromboembolism.

IMPORTANT SAFETY INFORMATION and INDICATIONS 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, 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. CONTRAINDICATIONS

• Active pathological bleeding • Severe hypersensitivity reaction to ELIQUIS
(e.g., anaphylactic reactions)

WARNINGS AND PRECAUTIONS

• 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.

ADVERSE REACTIONS

• The most common and most serious adverse reactions reported with ELIQUIS were
related to bleeding.

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 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.

DRUG INTERACTIONS

• 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.

PREGNANCY

• 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.

LACTATION

• 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.

INDICATIONS 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.

 

This advertisement is intended only for health care professionals in the United
States. You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, or call 1-8‌0‌0‌-FDA-1‌0‌8‌8. Bristol
Myers Squibb and Pfizer are committed to transparency. For information on the
list price of ELIQUIS as well as information regarding average out-of-pocket
costs and assistance programs, please visit our pricing information pages at
ELIQUIS VTE and ELIQUIS NVAF. By unsubscribing from e-M.D./alert you are not
opting out of email marketing
communication from Bristol-Myers Squibb.





Legal Notice | Privacy Policy | CONTACT ELIQUIS® and the ELIQUIS logo are
trademarks of
Bristol-Myers Squibb Company. All other trademarks are the property of their
respective owners. © 2‌0‌2‌3 Bristol-Myers Squibb Company.
4‌3‌2-US-2‌20‌0‌5‌4‌4 0‌2/2‌3


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