Xareltot (rivaroxaban) Prescriber Guide - April 2021 - HPRA
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Xarelto®t (rivaroxaban) Prescriber Guide April 2021 PP-XAR-IE-0161-4
Contents
Prescriber Guide 4 Prevention of VTE in adult patients undergoing elective hip- or knee-
replacement surgery 14
Patient Alert Card 4
Duration of treatment 14
Dosing Recommendations 4
Missed dose 14
Stroke prevention in adult patients with non-valvular atrial fibrillation 4
Patients with renal impairment 5 Oral Intake 14
Duration of therapy 5 Perioperative Management 15
Missed dose 5 Spinal/Epidural Anaesthesia or Puncture 15
Patients undergoing PCI with stent placement 5 Converting from VKA to Xarelto ®
16
Patients undergoing cardioversion 5 Converting from Xarelto to VKA
®
17
Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and Converting from Parenteral Anticoagulants to Xarelto® 18
prevention of recurrent DVT and PE in adult patients and treatment of VTE
and prevention of recurrence in children and adolescents 6 Converting from Xarelto® to Parenteral Anticoagulants 18
Patients with renal impairment 8 Populations Potentially at Higher Risk of Bleeding 18
Duration of therapy 8 Patients with renal impairment 19
Missed dose 9 Patients concomitantly receiving other medicinal products 19
Prevention of atherothrombotic events in adult patients with coronary Patients with other haemorrhagic risk factors 19
artery disease (CAD) or symptomatic peripheral artery disease (PAD) at
high risk of ischaemic events 10 Other Contraindications 20
Patients with renal impairment 10 Overdose 20
Duration of therapy 10 Coagulation Testing 21
Other warnings and precautions in CAD/PAD patients 10 Dosing Overview in Adults 22
Missed dose 11
Prevention of atherothrombotic events in adult patients after an acute
coronary syndrome (ACS) with elevated cardiac biomarkers 12
Patients with renal impairment 12
Duration of therapy 12
Other warnings and precautions in ACS patients 12
Missed dose 13
2 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 3Prescriber Guide Patients with renal impairment
In patients with moderate (creatinine clearance [CrCl] 30–49 ml/min) or severe (CrCl
The Prescriber Guide provides recommendations for the use of Xarelto® in order to 15–29 ml/min) renal impairment the recommended dose is 15 mg once daily. Xarelto®
minimise the risk of bleeding during treatment with Xarelto®. is to be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min)
For further information and additional details on Xarelto®, please see the Summary of and is not recommended in patients with CrClTreatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and If the oral suspension is prescribed, the patient or caregiver should be advised to
prevention of recurrent DVT and PE in adult patients and treatment of VTE and carefully read and follow the Instructions for Use (IFU) provided in the box of Xarelto®
prevention of recurrence in children and adolescents granules for oral suspension. The IFU shows how to prepare and take or give the
Xarelto® oral suspension.
Adults
Adult patients are initially treated with Xarelto® 15 mg twice daily for the first 3 weeks. It is recommended to advise the patient or caregiver which blue syringe (Liquid Dosing
This initial treatment is followed by Xarelto® 20 mg once daily for the continued treatment Device) to use to ensure that the correct volume is administered.
period. When extended prevention of recurrent DVT and PE is indicated (following If the oral suspension is prescribed, the prescriber should remind the patient or caregiver
completion of at least 6 months’ therapy for DVT or PE), the recommended dose is 10 of the individual weight-adjusted dose volume and frequency. Upon dispensation of the
mg once daily. In patients in whom the risk of recurrent DVT or PE is considered high, medication to the patient or caregiver, the dispensing health care provider (e.g. the
such as those with complicated co-morbidities, or who have developed recurrent DVT pharmacist) should write the prescribed dose on the outer carton of the box.
or PE on extended prevention with Xarelto® 10 mg once daily, a dose of Xarelto® 20 mg
once daily should be considered. Body-weight-adjusted Xarelto® dosing schedule for children from birth to less
than 18 years of age in ml of suspension and mg of tablets
Xarelto® 10 mg is not recommended for the initial 6 months’ treatment of DVT or PE.
Total daily dose
ADULT DOSING SCHEME Pharmaceutical Body weight Regimen [mg]
[mg]
form [kg] (1 mg=1 ml suspension)
(1 mg=1 ml)
Following completion of at least
Day 1 to 21 Day 22 onwards
6 months OD BID TID
Min Max once 2 times 3 times
a day a day a day
Xarelto 15 mg Xarelto 20 mg Xarelto 10 mg Xarelto 20 mg
once daily*
twice daily* once daily* once daily* 2.6Patients with renal impairment Children aged
Prevention of atherothrombotic events in adult patients with coronary artery Xarelto® co-administered with ASA should be used with caution in CAD/PAD patients:
disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of
u ≥ 75 years of age. The benefit-risk of the treatment should be individually assessed
ischaemic events
on a regular basis
ADULT DOSING SCHEME u With a lower weight (Prevention of atherothrombotic events in adult patients after an acute coronary Missed dose
syndrome (ACS) with elevated cardiac biomarkers
If a dose is missed, the patient should continue with the regular 2.5 mg Xarelto® dose
as recommended at the next scheduled time. The dose should not be doubled to make
ADULT DOSING SCHEME
up for a missed dose.
Continuous treatment
Xarelto 2.5 mg twice daily*
*Xarelto 2.5 mg: TAKE WITH OR WITHOUT FOOD
The recommended dose of Xarelto® is 2.5 mg twice daily, starting as soon as possible
after stabilisation of the index ACS event but at the earliest 24 hours after hospital
admission and at the time when parenteral anticoagulation therapy would normally be
discontinued.
In addition to Xarelto® 2.5 mg, patients should also take a daily dose of 75–100 mg
acetylsalicylic acid (ASA) or a daily dose of 75–100 mg ASA in addition to either a
daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
Treatment in combination with other antiplatelet agents, e.g. prasugrel or ticagrelor, has
not been studied and is not recommended.
Patients with renal impairment
No dose adjustment is required in patients with moderate renal impairment (CrCl 30–49
ml/min). Xarelto® is to be used with caution in patients with severe renal impairment
(CrCl 15–29 ml/min) and is not recommended in patients with CrClPrevention of VTE in adult patients undergoing elective hip- or knee-replacement
surgery
Perioperative Management
If an invasive procedure or surgical intervention is required, if possible and based on the
The recommended dose is 10 mg Xarelto® taken orally once daily. The initial dose should clinical judgement of the physician:
be taken 6 to 10 hours after surgery, provided that haemostasis has been established.
u Xarelto® 10/15/20 mg tablets and Xarelto® 1mg/ml granules for oral suspension
Duration of treatment should be stopped at least 24 hours before the intervention
The duration of treatment depends on the individual risk of the patient for venous u Xarelto® 2.5 mg should be stopped at least 12 hours before the intervention. If
thromboembolism which is determined by the type of orthopaedic surgery. the procedure cannot be delayed, the increased risk of bleeding should be assessed
u For patients undergoing major hip surgery, a treatment duration of 5 weeks is against the urgency of the intervention.
recommended Xarelto® should be restarted after the invasive procedure or surgical intervention as
soon as possible provided the clinical situation allows, and adequate haemostasis has
u For patients undergoing major knee surgery, a treatment duration of 2 weeks is been established.
recommended
Missed dose Spinal/Epidural Anaesthesia or Puncture
If a dose is missed, the patient should take Xarelto immediately and then continue the
® When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is
following day with once daily intake as before. employed, patients treated with antithrombotic agents for prevention of thromboembolic
complications are at risk of developing an epidural or spinal haematoma, which can
Oral Intake result in long-term or permanent paralysis. The risk of these events may be increased
by the post-operative use of indwelling epidural catheters or the concomitant use of
Xarelto® 2.5 mg and 10 mg tablets can be taken with or without food. medicinal products affecting haemostasis. The risk may also be increased by traumatic
Xarelto® 1 mg/ml granules for oral suspension, Xarelto® 15 mg and 20 mg tablets or repeated epidural or spinal puncture. Patients are to be frequently monitored for signs
are to be taken with food. The intake of these doses with food at the same time and symptoms of neurological impairment (e.g. numbness or weakness of the legs,
supports the required absorption of the drug, thus ensuring a high oral bioavailability. bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis
and treatment is necessary. Prior to neuraxial intervention the physician should consider
Adults the potential benefit versus the risk in anticoagulated patients or in patients to be
anticoagulated for thromboprophylaxis.
For patients who are unable to swallow whole tablets, a Xarelto® tablet may be crushed
and mixed with water or apple puree immediately prior to use and then administered For indication-specific recommendations, please refer to the sections below:
orally. After the administration of crushed Xarelto® 15 mg or 20 mg film-coated tablets, u Prevention of stroke and systemic embolism in adult patients with NVAF
the dose should be immediately followed by food.
u Treatment of DVT and PE and prevention of recurrent DVT and PE in adult patients
The crushed Xarelto® tablet may also be given through gastric tubes after confirmation
of the correct gastric placement of the tube. The crushed tablet should be administered u Treatment of VTE and prevention of VTE recurrence in children
in a small amount of water via a gastric tube, after which it should be flushed with water. There is no clinical experience with the use of 15 mg and 20 mg Xarelto® tablets in adults
After the administration of crushed Xarelto® 15 mg or 20 mg film-coated tablets, the nor with the use of Xarelto® in children in these situations. To reduce the potential risk of
dose should then be immediately followed by enteral feeding. bleeding associated with the concurrent use of Xarelto® and neuraxial (epidural/spinal)
anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban.
Children
Placement or removal of an epidural catheter or lumbar puncture is best performed
For children weighing ≥30 kg who are unable to swallow whole tablets, Xarelto® granules when the anticoagulant effect of Xarelto® is estimated to be low. However, the exact
for oral suspension should be used. If the oral suspension is not immediately available, timing to reach a sufficiently low anticoagulant effect in each patient is not known and
when doses of Xarelto® 15 mg or 20 mg are prescribed, these could be provided by should be weighed against the urgency of a diagnostic procedure.
crushing the 15 mg or 20 mg tablet and mixing it with water or apple puree immediately For the removal of an epidural catheter and based on the general pharmacokinetic
prior to use and administered orally. characteristics at least 2x half-life, i.e. at least 18 hours in young adult patients and
The oral suspension and the crushed Xarelto® tablet may be given through nasogastric 26 hours in elderly patients should elapse after the last administration of Xarelto® (see
or gastric feeding tube. Gastric placement of the tube should be confirmed before section 5.2 of the SmPC). Following removal of the catheter, at least 6 hours should
administering Xarelto®. Avoid administration of Xarelto® distal to the stomach. elapse before the next Xarelto® dose is administered. If traumatic puncture occurs, the
administration of Xarelto® is to be delayed for 24 hours.
14 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 15No data is available on the timing of placement or removal of a neuraxial catheter in For patients treated for prevention of stroke and systemic embolism, treatment with
children while on Xarelto®. Discontinue Xarelto® and consider a short acting parenteral VKA should be stopped and Xarelto® therapy should be initiated when the INR ≤3.0.
anticoagulant.
For adult patients treated for DVT, PE and prevention of recurrent DVT and PE and
u Prevention of VTE in adult patients undergoing elective hip or knee replacement treatment of VTE and prevention of recurrence in paediatric patients, treatment with
surgery VKA should be stopped and Xarelto® therapy should be initiated when the INR ≤2.5.
To reduce the potential risk of bleeding associated with the concurrent use of INR measurement is not appropriate to measure the anticoagulant activity of Xarelto®,
Xarelto® and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the and therefore should not be used for this purpose. Treatment with Xarelto® only does
pharmacokinetic profile of Xarelto®. not require routine coagulation monitoring.
Placement or removal of an epidural catheter or lumbar puncture is best performed
when the anticoagulant effect of Xarelto® is estimated to be low (see section 5.2 of the Converting from Xarelto® to VKA
SmPC).
CONVERTING FROM XARELTO TO VKA
At least 18 hours should elapse after the last administration of Xarelto® before removal
of an epidural catheter. Following removal of the catheter, at least 6 hours should
elapse before the next Xarelto® dose is administered. If traumatic puncture occurs the Standard VKA dose INR adapted VKA dose
administration of Xarelto® is to be delayed for 24 hours.
Xarelto can
u Prevention of atherothrombotic events in adult patients with coronary artery disease Xarelto* INR testing be stopped
before Xarelto once INR≥2.0
(CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events
administration
u Prevention of atherothrombotic events in adult patients after an ACS with elevated days
cardiac biomarkers
There is no clinical experience with the use of Xarelto® 2.5 mg with ASA alone or with
ASA plus clopidogrel or ticlopidine in these situations. To reduce the potential risk of *See dosing recommendations for required daily dose
bleeding associated with the concurrent use of Xarelto® and neuraxial (epidural/spinal)
anaesthesia or spinal puncture, consider the pharmacokinetic profile of Xarelto®.
It is important to ensure adequate anticoagulation while minimising the risk of bleeding
Placement or removal of an epidural catheter or lumbar puncture is best performed during conversion of therapy.
when the anticoagulant effect of Xarelto® is estimated to be low (see section 5.2 of the
SmPC). However, the exact timing to reach a sufficiently low anticoagulant effect in Adults
each patient is not known. Platelet aggregation inhibitors should be discontinued as When converting to VKA, Xarelto® and VKA should be given overlapping until the INR
suggested by the manufacturer’s prescribing information. ≥2.0. For the first 2 days of the conversion period, standard initial dosing of VKA should
be used followed by VKA dosing guided by INR testing.
Converting from VKA to Xarelto® INR measurement is not appropriate to measure the anticoagulant activity of Xarelto®.
CONVERTING FROM VKA TO XARELTO While patients are on both Xarelto® and VKA the INR should not be tested earlier than
24 hours after the previous dose but prior to the next dose of Xarelto®. Once Xarelto®
Stop VKA is discontinued, INR values obtained at least 24 hours after the last dose reliably reflect
the VKA dosing.
VKA Xarelto*
Children
INR testing Preventition of stroke and systemic embolism
(duration according Initiate Xarelto once INR ≤3.0 Children who convert from Xarelto® to VKA need to continue Xarelto® for 48 hours after
to individual DVT, PE and prevention of
the first dose of VKA. After 2 days of co-administration an INR should be obtained
decrease of VKA recurrent DVT and PE:
plasma levels) Initiate Xarelto once INR ≤2.5 prior to the next scheduled dose of Xarelto®. Co-administration of Xarelto® and VKA
days is advised to continue until the INR is ≥ 2.0. Once Xarelto® is discontinued, INR values
obtained at least 24 hours after the last dose reliably reflect the VKA dosing.
*See dosing recommendations for required daily dose
16 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 17Converting from Parenteral Anticoagulants to Patients with renal impairment
For adults see dosing recommendations for patients with moderate (CrCl 30–49 ml/min)
Xarelto® or severe (CrCl 15–29 ml/min) renal impairment. Xarelto® is to be used with caution in
u Patients with a parenteral drug on a fixed dosing scheme such as low-molecular- patients with CrCl 15–29 ml/min and in patients with renal impairment* concomitantly
weight heparin (LMWH): Discontinue parenteral drug and start Xarelto® 0 to 2 hours receiving other medicinal products, that increase rivaroxaban plasma concentrations.
before the time of the next scheduled administration of the parenteral drug Use of Xarelto® is not recommended in patients with CrClOther Contraindications Coagulation Testing
Xarelto is contraindicated during pregnancy and breastfeeding. Women of child-
®
Xarelto® does not require routine coagulation monitoring. However, measuring Xarelto®
bearing potential should avoid becoming pregnant during treatment with Xarelto®. levels may be useful in exceptional situations where knowledge of Xarelto® exposure
Xarelto® is also contraindicated in case of hypersensitivity to the active substance or to may help to take clinical decisions, e.g. overdose and emergency surgery.
any of the excipients.
Anti-FXa assays with Xarelto® specific calibrators to measure rivaroxaban levels are
commercially available. If clinically indicated haemostatic status can also be assessed
Overdose by prothrombin time (PT) using Neoplastin as described in the SmPC.
Due to limited absorption, a ceiling effect with no further increase in average plasma The following coagulation tests are increased: PT, activated partial thromboplastin time
exposure is expected at supratherapeutic doses of 50 mg Xarelto® and above in adults; (aPTT) and calculated PT INR. Since the INR was developed to assess the effects of
however, no data is available at supratherapeutic doses in children. A decrease in the VKAs on the PT, it is therefore not appropriate to use the INR to measure activity of
relative bioavailability for increasing doses (in mg/kg bodyweight) was found in children, Xarelto®.
suggesting absorption limitations for higher doses, even when taken together with food.
A specific reversal agent antagonising the pharmacodynamic effect of rivaroxaban is Dosing or treatment decisions should not be based on results of INR except when
available (refer to the Summary of Product Characteristics of andexanet alfa), however, converting from Xarelto® to VKA as described above.
it is not established in children. The use of activated charcoal to reduce absorption in
case of overdose may be considered.
Should a bleeding complication arise in a patient receiving Xarelto®, the next Xarelto®
administration should be delayed or treatment should be discontinued as appropriate.
Individualised bleeding management may include:
u Symptomatic treatment, such as mechanical compression, surgical intervention,
fluid replacement
u Haemodynamic support, blood product or component transfusion
u If bleeding cannot be controlled with the above measures, either the administration
of a specific factor Xa inhibitor reversal agent (andexanet alfa) or a specific procoagulant
reversal agent, such as prothrombin complex concentrate (PCC), activated prothrombin
complex concentrate (APCC) or recombinant factor VIIa (r-FVIIa) should be considered.
However, there is currently very limited clinical experience with the use of these
medicinal products in adults and in children receiving Xarelto®.
Due to the high plasma protein binding, Xarelto® is not expected to be dialysable.
20 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 21Dosing
Dosing
DosingOverview
Overview in in
Overview Adults
in
Adults*
Adults*
INDICATION
INDICATION
1 1
DOSING
DOSING
1 1
SPECIAL
SPECIAL
POPULATIONS
POPULATIONS
1 1
INDICATION
INDICATION
1 1
DOSING
DOSING
1 1
SPECIAL
SPECIAL
POPULATIONS
POPULATIONS
1 1
StrokeStroke
prevention
prevention in adult Xarelto
in adult Xarelto
®
20 mg
®
20once
mg once
dailydaily In patients
In patients
with with
impaired
impaired Prevention
Prevention
of atherothrombotic
of atherothrombotic
Xarelto
Xarelto
®
2.5 ®mg
2.5twice
mg twice
dailydaily
patients
patients
with with
non-valvular
non-valvular renalrenal
function
function
with with events
events
in adult
in adult
patients
patients
with with in combination
in combination
atrialatrial
fibrillation
fibrillation
a a CrCl 15–49
CrCl 15–49
ml/min
ml/minb
b
CAD CAD
or symptomatic
or symptomatic PAD PAD
at atwithwith
acetylsalicylic
acetylsalicylic
acid acid
Xarelto
Xarelto
15 mg 15once
mg once
dailydaily high high
risk ofrisk
ischaemic
of ischaemic
events
events 75–100
75–100
mg/day
mg/day
PCI with
PCI with
stent stent
placement
placement
For a For
maximum
a maximumof 12of
months
12 months
Xarelto
Xarelto
15 mg 15once
mg once
dailydaily
plus aplus
P2Y12
a P2Y12
inhibitor
inhibitor
(e.g. clopidogrel)
(e.g. clopidogrel) Prevention
Prevention
of atherothrombotic
of atherothrombotic Xarelto
Xarelto
2.5 mg
2.5twice
mg twice
dailydaily
events
events
in adult
in adult
patients
patients
after after in combination
in combinationwithwith
PCI with
PCI with
stent stent
placement
placement
in in an ACS ACS with
an with elevated
elevated
cardiac
cardiac standard
standard
antiplatelet
antiplatelet
therapy
therapy
patients
patients
with with
impaired
impaired
renalrenal biomarkers
biomarkers (acetylsalicylic
(acetylsalicylic
acid 75–100
acid 75–100
mg/ mg/
function
function
with with
creatinine
creatinine day alone
day alone
or acetylsalicylic
or acetylsalicylic
acid acid
clearance
clearance
30–4930–49
ml/minml/min
b b
75–100mg/day
75–100mg/day
plus clopidogrel
plus clopidogrel
Xarelto
Xarelto
10 mg 10once
mg once
dailydaily 75 mg/day
75 mg/day
or a standard
or a standard
dose dose
of of
plus aplus
P2Y12
a P2Y12
inhibitor
inhibitor ticlopidine)
ticlopidine)
(e.g. clopidogrel)
(e.g. clopidogrel)
Treatment of DVT
Treatment DVTPE
of and and
C Treatment
PEC, and
, and Treatment
and prevention of of In patients
and prevention In patients
with with
impaired
impaired
renalrenal
prevention
prevention
of recurrent DVT DVT recurrence,
of recurrent recurrence,
day 1–21
day 1–21 function
function
with with
CrCl CrCl
and PE
and
in PE
adult
in adult
patients
patients Xarelto
Xarelto
15 mg15twice
mg twice
dailydaily 15–49ml/min
15–49ml/min
b b
Xarelto 15 mg
Xarelto 15 and
mg and
20 mg
20 must
mg must
be taken
be taken
withwith
foodfood
1 1
Prevention
Prevention
of recurrence, from from Treatment
of recurrence, Treatment
and prevention
and prevention
of of
day 22
day
onwards
22 onwards recurrence,
recurrence,
day 1–21
day 1–21 For patients
For patients
who are
whounable
are unable
to swallow
to swallow
wholewhole
tablets,
tablets,
Xarelto
Xarelto
tablettablet
may bemay
crushed
be crushed
and and
Xarelto
Xarelto
20 mg20once
mg once
dailydaily Xarelto
Xarelto
15 mg15twice
mg twice
dailydaily mixedmixed
with water
with water
or apple
or apple
pureepuree
immediately
immediately
prior to
prior
usetoand
useadministered
and administered
orally.orally.
a
Withaone
Withorone
more
or more
risk factors,
risk factors,
such as
such
congestive
as congestive
heart heart
failure,
failure,
hypertension,
hypertension,
Extended
Extended
prevention
prevention Thereafter Xarelto
Thereafter Xarelto
15mg 15mg age ≥75
ageyears,
≥75 years,
diabetes
diabetes
mellitus,
mellitus,
prior stroke
prior stroke
or transient
or transient
ischaemic
ischaemic
attack.
attack.
of recurrence,
of recurrence,
from from onceonce
dailydaily
instead
instead
of Xarelto
of Xarelto
monthmonth
7 onwards
7 onwards 20mg20mg
once once
daily daily
if patient’s
if patient’s Use with
b b
Use caution
with caution
in patients
in patients
with creatinine
with creatinine
clearance
clearance
15–2915–29
ml/minml/min
and inand
patients
in patients
with renal
with renal
impairment
impairment
Xarelto
Xarelto
10 mg 10once
mg once
dailydaily assessed
assessed
risk for
riskbleeding
for bleeding whenwhen
concomitantly
concomitantly
receiving
receiving
other other
medicinal
medicinal
products
products
that increase
that increase
rivaroxaban
rivaroxaban
plasma
plasma
concentration.
concentration.
outweighs
outweighs
risk for
riskrecurrence
for recurrence Not recommended
c c
Not recommended
as an as
alternative
an alternative
to unfractionated
to unfractionated
heparin
heparin
in patients
in patients
with PE
with
whoPE are
who are
Extended
Extended
prevention
prevention haemodynamically
haemodynamically
unstable
unstable
or mayorreceive
may receive
thrombolysis
thrombolysis
or pulmonary
or pulmonary
embolectomy.
embolectomy.
of recurrence,
of recurrence,
from from WhenWhenthe recommended
the recommended dose dose
monthmonth
7 onwards
7 onwards is Xarelto
is Xarelto
10 mg 10once
mg once
daily,daily,
no no Reference:
Reference:
1. Xarelto
1. Xarelto
(rivaroxaban).
(rivaroxaban).
Summary
Summary
of Product
of Product
Characteristics,
Characteristics,
as approved
as approved
by thebyEuropean
the European
Commission.
Commission.
Xarelto
Xarelto
20 mg 20once
mg once
dailydaily dose dose
adjustment
adjustment
is necessary
is necessary
in patients
in patients
at high
at high
risk of
risk of
recurrent
recurrent
DVT or DVT
PE,orsuch
PE, as
such as
those:those: Dosing Overview
Dosing Overviewin Children and Adolescents
in Children and Adolescents
Dosing Overview in Children and Adolescents
For dosing for the
For dosing fortreatment of VTEofand
the treatment VTEprevention of recurrence
and prevention in paediatric
of recurrence patients
in paediatric pleaseplease
patients refer to theto the
refer
with with
complicated
complicated
comorbidities
comorbidities body-weight-adjusted
body-weight-adjustedXarelto dosingdosing
Xarelto table table
on page 7.
on page 7.
who have
who have
developed
developed
recurrent
recurrent
DVT or
DVT
PEor
onPE
extended
on extended For dosing for the treatment of VTE and prevention of recurrence in paediatric
ACS, ACS,
acute acute
coronary syndrome;
coronary ASA, ASA,
syndrome; acetylsalicylic acid; BID,
acetylsalicylic acid;twice daily; daily;
BID, twice CAD, CAD,
coronary arteryartery
coronary disease;
disease;
prevention
prevention
with with
Xarelto
Xarelto
10 mg10 mg CrCl, patients
creatinine
CrCl, please
clearance;
creatinine refer
DVT,
clearance; deep
DVT, todeep
the
vein body-weight-adjusted
thrombosis;
vein GFR, glomerular
thrombosis; Xarelto
filtration
GFR, glomerular rate; HIV,
filtration dosing
rate;human table on page
immunodeficiency
HIV, human immunodeficiency 7.virus;
virus;
Prevention
Prevention
of VTE
ofinVTE
adults
in adults Xarelto
Xarelto
10 mg
10once
mg once
dailydaily INR, international normalised
INR, international ratio; ratio;
normalised LMWH, low-molecular-weight
LMWH, heparin;
low-molecular-weight NSAID,
heparin; non-steroidal
NSAID, anti-inflammatory
non-steroidal anti-inflammatorydrug; drug;
undergoing
undergoing
elective hip or
elective hip or NVAF,NVAF,
non-valvular atrial atrial
non-valvular fibrillation; OD, once
fibrillation; OD, daily; PAD, PAD,
once daily; peripheral arteryartery
peripheral disease; PCI, percutaneous
disease; coronary
PCI, percutaneous intervention;
coronary intervention;
kneeknee
replacement
replacement
surgery
surgery PE, pulmonary embolism;
PE, pulmonary SmPC,SmPC,
embolism; Summary of Product
Summary Characteristics;
of Product SPAF,SPAF,
Characteristics; strokestroke
prevention in atrial
prevention fibrillation;
in atrial fibrillation;
TID, three times times
TID, three daily; daily;
VKA, VKA,
vitamin K antagonist;
vitamin VTE, venous
K antagonist; thromboembolism;
VTE, venous thromboembolism; UFH, unfractionated heparin.
UFH, unfractionated heparin.
ACS, acute coronary syndrome; ASA, acetylsalicylic acid; BID, twice daily; CAD, coronary artery disease; CrCl,
creatinine clearance; DVT, deep vein thrombosis; GFR, glomerular filtration rate; HIV, human immunodeficiency virus;
INR, international normalised ratio; LMWH, low-molecular-weight heparin; NSAID, non-steroidal anti-inflammatory
drug; NVAF, non-valvular atrial fibrillation; OD, once daily; PAD, peripheral artery disease; PCI, percutaneous coronary
intervention; PE, pulmonary embolism; SmPC, Summary of Product Characteristics; SPAF, stroke prevention in atrial
fibrillation; TID, three times daily; VKA, vitamin K antagonist; VTE, venous thromboembolism; UFH, unfractionated heparin.
22 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 23Notes Notes 24 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 25
Notes Notes 26 PP-XAR-IE-0161-4 PP-XAR-IE-0161-4 27
tThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse events. PP-XAR-IE-0161-4 ©Bayer AG, April 2021
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