LIXIANA15 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EDOXABAN AS TOSYLATE

Available from:

MEDISON PHARMA LTD

ATC code:

B01AF03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

EDOXABAN AS TOSYLATE 15 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DAIICHI SANKYO EUROPE GMBH

Therapeutic area:

EDOXABAN

Therapeutic indications:

• Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years,diabetes mellitus, prior stroke or transient ischaemic attack (TIA).• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults

Authorization date:

2021-03-01

Patient Information leaflet

Prescriber
Guide
LIXIANA
®
(edoxaban)
THIS GUIDE IS SPECIFICALLY FOR PRESCRIBERS IN
RELATION TO THE USE OF LIXIANA
®
(EDOXABAN).
IT INCLUDES INFORMATION ON THE FOLLOWING:
Please consult the Physician Prescribing Information (PPI) for full
prescribing information.
• Indications
• Dosing recommendations and dose reduction
• Populations at higher risk of bleeding
• Information on switching patients to or from Lixiana
®
• Perioperative management
• Temporary discontinuation
• Overdose
• Bleeding complications
• Coagulation testing
• Patient alert card
Lixiana
®
(edoxaban) is indicated for:
• Prevention of stroke and systemic embolism in adult patients with
nonvalvular atrial fibrillation
(NVAF) with one or more risk factors, such as congestive heart
failure, hypertension, age ≥75
years, diabetes mellitus, prior stroke or transient ischaemic attack
(TIA).
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism
(PE), and prevention of
recurrent DVT and PE in adults.
3
DOSING
INDICATIONS
THE RECOMMENDED DOSE OF LIXIANA
®
IS 60 MG IN A ONCE-DAILY TABLET.
Due to the importance of compliance, patients should be encouraged to
take their dose at the
same time every day.
It can be taken with water, with or without food.
Treatment with Lixiana
®
in patients with NVAF should be continued long term.
The duration of treatment for venous thromboembolism (VTE) and
prevention of recurrent VTE
should be individualised after assessment of the treatment benefit
against the risk for bleeding.
Short duration of therapy (at least 3 months) should be based on
transient risk factors (e.g. recent
surgery, trauma, immobilisation) and longer durations should be based
on permanent risk factors or
idiopathic DVT or PE.
4
DOSE REDUCTION
A dose of 30 mg once daily is required for certain patients
who fall into one or more of the following sub-groups.
These are:
In this case, patients should take one 30 mg tablet at the
same time every day, with or without food.
CrCl should be assessed and monitored at the
b

Summary of Product characteristics

PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Lixiana 15 mg film-coated tablets
Lixiana 30 mg film-coated tablets
Lixiana 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lixiana 15 mg film-coated tablets
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Lixiana 30 mg film-coated tablets
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Lixiana 60 mg film-coated tablets
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Lixiana 15 mg film-coated tablets
Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed
with “DSC L15”.
Lixiana 30 mg film-coated tablets
Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with
“DSC L30”.
Lixiana 60 mg film-coated tablets
Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed
with “DSC L60”.
Patient safety information card
The marketing of Lixiana is subject to a Risk management plan (RMP)
including a 'patient safety
information card'. The 'patient safety information card', emphasizes
important safety information that the
patient should be aware of before and during the treatment. Please
explain to the patient the need to
review the card before starting treatment.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Lixiana is indicated in prevention of stroke and systemic embolism in
adult patients with nonvalvular
atrial fibrillation (NVAF) with one or more risk factors, such as
congestive heart failure, hypertension,
age ≥ 75 years, diabetes mellitus, prior stroke or transient
ischaemic attack (TIA).
Lixiana is indicated in treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and
for the prevention of recurrent DVT and PE in adults (see section 4.4
for haemodynamically unstable
PE patients).
4.2
Posology and method of administration
Posology
_Prevention of stroke and systemic embolism _
The recommended dose is 60 mg edo