XARELTO- rivaroxaban tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

RIVAROXABAN (UNII: 9NDF7JZ4M3) (RIVAROXABAN - UNII:9NDF7JZ4M3)

Fáanlegur frá:

A-S Medication Solutions

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

XARELTO is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1)]. XARELTO is indicated for the treatment of deep vein thrombosis (DVT). XARELTO is indicated for the treatment of pulmonary embolism (PE). XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboemb

Vörulýsing:

Product: 50090-4469 NDC: 50090-4469-0 90 TABLET, FILM COATED in a BOTTLE

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

A-S Medication Solutions
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration Revised: 03/2020
MEDICATION GUIDE
XARELTO® (zah-REL-toe)
(rivaroxaban)
tablets
What is the most important information I should know about XARELTO?
XARELTO may cause serious side effects, including:
•
Increased risk of blood clots if you stop taking XARELTO. People with
atrial fibrillation (a type
of irregular heart beat) that is not caused by a heart valve problem
(non-valvular) 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. XARELTO lowers your chance of having a
stroke by helping to
prevent clots from forming. If you stop taking XARELTO, you may have
increased risk of
forming a clot in your blood.
Do not stop taking XARELTO without talking to the doctor who
prescribes it for you. Stopping
XARELTO increases your risk of having a stroke. If you have to stop
taking XARELTO, your
doctor may prescribe another blood thinner medicine to prevent a blood
clot from forming.
•
Increased risk of bleeding. XARELTO can cause bleeding which can be
serious and may lead to
death. This is because XARELTO is a blood thinner medicine
(anticoagulant) that lowers blood
clotting. During treatment with XARELTO you are likely to bruise more
easily, and it may take
longer for bleeding to stop. You may have a higher risk of bleeding if
you take XARELTO and
have certain other medical problems.
You may have a higher risk of bleeding if you take XARELTO and take
other medicines that
increase your risk of bleeding, including:
•
aspirin or aspirin containing products
•
long-term (chronic) use of non-steroidal anti-inflammatory drugs
(NSAIDs)
•
warfarin sodium (Coumadin®, Jantoven®)
•
any medicine that contains heparin
•
clopidogrel (Plavix®)
•
selective serotonin reuptake inhibitors (SSRIs) or serotonin
norepinephrine reuptake
inhibitors (SNRIs)
•
other medicines to prevent or treat blood clots
Tell your doctor i

Vara einkenni

XARELTO- RIVAROXABAN TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XARELTO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XARELTO.
XARELTO (RIVAROXABAN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK
OF
THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF
THROMBOTIC EVENTS
PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING
XARELTO, INCREASES THE
RISK OF THROMBOTIC EVENTS. TO REDUCE THIS RISK, CONSIDER COVERAGE WITH
ANOTHER
ANTICOAGULANT IF XARELTO IS DISCONTINUED FOR A REASON OTHER THAN
PATHOLOGICAL BLEEDING
OR COMPLETION OF A COURSE OF THERAPY. (2.2, 2.3, 5.1, 14.1)
(B) SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH
XARELTO WHO ARE
RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE
HEMATOMAS MAY
RESULT IN LONG-TERM OR PERMANENT PARALYSIS. (5.2, 5.3, 6.2)
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT AND IF
OBSERVED, TREAT URGENTLY. CONSIDER THE BENEFITS AND RISKS BEFORE
NEURAXIAL INTERVENTION
IN PATIENTS WHO ARE OR WHO NEED TO BE ANTICOAGULATED. (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions (5.8)
03/2020
INDICATIONS AND USAGE
XARELTO is a factor Xa inhibitor indicated:
to reduce risk of stroke and systemic embolism in nonvalvular atrial
fibrillation (1.1)
for treatment of deep vein thrombosis (DVT) (1.2)
for treatment of pulmonary embolism (PE) (1.3)
for reduction in the risk of recurrence of DVT or PE (1.4)
for the prophylaxis of DVT, which may lead to PE in patients
undergoing knee or hip replacement
surgery (1.5)
for prophylaxis of venous thromboembolism (VTE) in acutely ill medical
patients (1.6)
to reduce the risk of major cardiovascular events in patients with
chronic coronary art