ELIQUIS- apixaban tablet, film coated ELIQUIS 30-DAY STARTER PACK- apixaban kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

apixaban (UNII: 3Z9Y7UWC1J) (apixaban - UNII:3Z9Y7UWC1J)

Available from:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

apixaban

Composition:

apixaban 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIQUIS 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: 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. In animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposu

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

ELIQUIS- apixaban tablet, film coated
ELIQUIS 30-DAY STARTER PACK- apixaban
E.R. Squibb & Sons, L.L.C.
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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:
●

Summary of Product characteristics

ELIQUIS- APIXABAN TABLET, FILM COATED
ELIQUIS 30-DAY STARTER PACK- APIXABAN
E.R. SQUIBB & SONS, L.L.C.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELIQUIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELIQUIS.
ELIQUIS (APIXABAN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK
OF
THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
(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. TO REDUCE THIS RISK, CONSIDER
COVERAGE WITH
ANOTHER ANTICOAGULANT IF ELIQUIS IS DISCONTINUED FOR A REASON OTHER
THAN PATHOLOGICAL
BLEEDING OR COMPLETION OF A COURSE OF THERAPY. (2.4, 5.1, 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. (5.3)
INDICATIONS AND USAGE
ELIQUIS is a factor Xa inhibitor indicated:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
®
to reduce the risk of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation. (1.1)
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. (1.2)
for the treatment of DVT and PE, and for the reduction in the risk of
recurrent DVT and PE following
initial therapy. (1.3, 1.4, 1.5)
Reduction of risk of stroke and systemic embolism in nonvalvular
atrial fibrillation:
•
•
The recommended dose is 5 mg orally twice daily. (2.1)
In patients with at least 2 of the following characteristics: age
greater than or equal to 80