ELIQUIS- apixaban tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

APIXABAN (UNII: 3Z9Y7UWC1J) (APIXABAN - UNII:3Z9Y7UWC1J)

Available from:

RedPharm Drug, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIQUIS ® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 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. ELIQUIS is indicated for the treatment of PE. ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy. ELIQUIS is contraindicated in patients with the following conditions: - Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] - Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions) [see Adverse Reactions (6.1)] There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if t

Product summary:

ELIQUIS (apixaban) tablets are available as listed in the table below. 2.5 mg Yellow, round, Debossed with “893” on Bottles of 60 0003-0893-21 biconvex one side and “2½” on the other side Hospital Unit-Dose Blister Package of 100 0003-0893-31 5 mg Pink, oval, biconvex Debossed with “894” on Bottles of 60 0003-0894-21 one side and “5” on the Bottles of 74 0003-0894-70 other side Hospital Unit-Dose Blister Package of 100 0003-0894-31 30-Day Starter Pack for Treatment of DVT and PE Containing 74 Tablets (1 blister pack of 42 tablets and 1 blister pack of 32 tablets) 0003-3764-74 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].

Authorization status:

New Drug Application

Patient Information leaflet

RedPharm Drug, Inc.
----------
MEDICATION GUIDE
ELIQUIS ® (ELL eh kwiss)
(apixaban)
tablets
What is the most important information I should know about ELIQUIS?
•
For people taking ELIQUIS for atrial fibrillation:
People with atrial fibrillation (a type of irregular heartbeat) are at
an increased risk of forming a
blood clot in the heart, which can travel to the brain, causing a
stroke, or to other parts of the body.
ELIQUIS lowers your chance of having a stroke by helping to prevent
clots from forming. If you
stop taking ELIQUIS, you may have increased risk of forming a clot in
your blood.
Do not stop taking ELIQUIS without talking to the doctor who
prescribes it for you. Stopping
ELIQUIS increases your risk of having a stroke.
ELIQUIS may need to be stopped, if possible, prior to surgery or a
medical or dental procedure.
Ask the doctor who prescribed ELIQUIS for you when you should stop
taking it. Your doctor will
tell you when you may start taking ELIQUIS again after your surgery or
procedure. If you have to
stop taking ELIQUIS, your doctor may prescribe another medicine to
help prevent a blood clot
from forming.
•
ELIQUIS can cause bleeding which can be serious and rarely may lead to
death. This is because
ELIQUIS is a blood thinner medicine that reduces blood clotting.
You may have a higher risk of bleeding if you take ELIQUIS and take
other medicines that
increase your risk of bleeding, including:
•
aspirin or aspirin-containing products
•
long-term (chronic) use of nonsteroidal anti-inflammatory drugs
(NSAIDs)
•
warfarin sodium (COUMADIN ®, JANTOVEN ®)
•
any medicine that contains heparin
•
selective serotonin reuptake inhibitors (SSRIs) or serotonin
norepinephrine reuptake
inhibitors (SNRIs)
•
other medicines to help prevent or treat blood clots
•
Tell your doctor if you take any of these medicines. Ask your doctor
or pharmacist if you are not
sure if your medicine is one listed above.
While taking ELIQUIS:
•
you may bruise more easily
•
it may take longer than usual for any bleedi

Summary of Product characteristics

ELIQUIS- APIXABAN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
ELIQUIS 5MG
BOXED WARNING
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK
OF THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF
THROMBOTIC EVENTS
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 [see Dosage and Administration (2.4), Warnings and
Precautions (5.1), and Clinical
Studies (14.1)].
(B) SPINAL/EPIDURAL HEMATOMA
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
[see Warnings and Precautions (5.3)]
Monitor patients frequently for signs and symptoms of neurological
impairment. If neurological
compromise is noted, urgent treatment is necessary [see Warnings and
Precautions (5.3)].
Consider the benefits and risks before neuraxial intervention in
patients anticoagulated or to be
anticoagulated [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
1.1 REDUCTION OF RISK OF STROKE AND SYSTEMIC EMBOLISM IN NONVALVULAR
ATRIAL FIBRILLATION
ELIQUIS
(apixaban) is indicated to reduce the risk of str