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:

Indoco Remedies Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban tablets are 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. Apixaban tablets are indicated for the treatment of DVT. Apixaban tablets are indicated for the treatment of PE. Apixaban tablets are indicated to reduce the risk of recurrent DVT and PE following initial therapy. Apixaban tablets are 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  apixaban (e.g.,  anaphylactic  reactions)  [see  Adverse Reactions (6.1)] Risk Summary The limited available data on apixaban tablets  use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental

Product summary:

How Supplied Apixaban tablets 2.5mg and 5mg are available as below. 2.5mg, yellow, round, film coated biconvex tablets debossed with "C31" on one side and plain on the other side. NDC 14445-149-60  Bottles of 60 NDC 14445-149-18  Bottles of 180 NDC 14445-149-05   Bottles of 500 NDC 14445-149-14   Unit-Dose Blister Package 10x 14's 5 mg, pink, oval, film coated biconvex tablets debossed with "C32" on one side and plain on the other side. NDC 14445-150-60  Bottles of 60 NDC 14445-150-18  Bottles of 180 NDC 14445-150-05   Bottles of 500 NDC 14445-150-10   Unit-Dose Blister Package 10x 10's 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

APIXABAN - apixaban tablet, film coated
Indoco Remedies Limited
----------
SPL MEDGUIDE SECTION
MEDICATION GUIDE
Apixaban (a PIX a ban) tablets
What is the most important information I should know about apixaban
tablets?
•
For people taking apixaban tablets 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. Apixaban lowers your
chance of having a stroke by helping to prevent clots from forming. If
you stop taking apixaban, you may
have increased risk of forming a clot in your blood.
Do not stop taking apixaban tablets without talking to the doctor who
prescribes it for you. Stopping
apixaban increases your risk of having a stroke.
Apixaban tablets may need to be stopped, if possible, prior to surgery
or a medical or dental procedure. Ask
the doctor who prescribed apixaban tablets for you when you should
stop taking it. Your doctor will tell you
when you may start taking apixaban tablets again after your surgery or
procedure. If you have to stop taking
apixaban tablets, your doctor may prescribe another medicine to help
prevent a blood clot from forming.
•
Apixaban can cause bleeding which can be serious and rarely may lead
to death. This is because
apixaban is a blood thinner medicine that reduces blood clotting.
You may have a higher risk of bleeding if you take apixaban tablets
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

Summary of Product characteristics

APIXABAN - APIXABAN TABLET, FILM COATED
INDOCO REMEDIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APIXABAN TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APIXABAN
TABLETS.
APIXABAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK
OF
THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
(A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF
THROMBOTIC
EVENTS: PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING
APIXABAN,
INCREASES THE RISK OF THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER
COVERAGE WITH
ANOTHER ANTICOAGULANT IF APIXABAN 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 APIXABAN 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Increased Risk of Thrombosis in Patients
with Triple Positive Antiphospholipid
Syndrome (5.6) 11/2019
INDICATIONS AND USAGE
Apixaban is a factor Xa inhibitor indicated:
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)
DOSAGE AND ADMINISTRATION
Reduction of risk of stroke and systemic embolism in nonvalvular
atrial fibrillation:
The recommended dose is 5 mg orally twice daily. (2.1)
I