HALAVEN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERIBULIN AS MESILATE

Available from:

EISAI ISRAEL LTD., ISRAEL

ATC code:

L01XX41

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ERIBULIN AS MESILATE 0.44 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

EISAI MANUFACTURING LIMITED, UK

Therapeutic group:

ERIBULIN

Therapeutic area:

ERIBULIN

Therapeutic indications:

Halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Authorization date:

2017-04-30

Patient Information leaflet

July 2019
HALAVEN (148-18-33511)
SOLUTION FOR INJECTION
,ה/דבכנ ת/חקור ,ה/אפור
−
ולעה
ן
אפורל
ן
כדוע
ן
ינויב
2019
.
−
.הרמחה םיווהמה םייונישה םיניוצמ וז
העדוהב
−
.יתחת וקב ןמוסמ ףסוותהש טסקט
:ליעפה רמוחה
One ml contains Eribulin Mesilate equivalent to 0.44 mg Eribulin.
Each 2 ml vial contains Eribulin Mesilate equivalent to 0.88 mg
Eribulin.
ןלהל
חסונ
היוותהה
מה
רשוא
רישכתל
:
HALAVEN is indicated for the treatment of adult patients with locally
advanced or metastatic breast cancer
who have progressed after at least one chemotherapeutic regimen for
advanced disease (see section 5.1).
Prior therapy should have included an anthracycline and a taxane in
either the adjuvant or metastatic setting
unless patients were not suitable for these treatments.
HALAVEN is indicated for the treatment of adult patients with
unresectable liposarcoma who have received
prior anthracycline containing therapy (unless unsuitable) for
advanced or metastatic disease (see section
5.1). :םיאבה םיפיעסב ושענ אפורל ןולעב
םיירקיעה םינוכדעה
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
(…)
QT prolongation
(…)
Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected
prior to initiating HALAVEN and
these electrolytes should be monitored periodically during therapy.
Eribulin should be avoided in patients with
congenital long QT syndrome.
4.8
UNDESIRABLE EFFECTS
VERY COMMON
(FREQUENCY %)
COMMON
(FREQUENCY %)
METABOLISM
AND
NUTRITION
DISORDERS
Decreased appetite
(22.5%) (G3/4: 0.7%)d
Hypokalaemia (6.8%) (G3/4: 2.0%)
Hypomagnesaemia
(2.8%) (G3/4: 0.3%)
Dehydration (2.8 %) (G3/4: 0.5%)
d
Hyperglycaemia
Hypophosphataemia
Hypocalcaemia
d
No Grade 4 events
ולעה
ן
אפורל
ןכרצלו
םימסרופמ
.תואירבה דרשמ רתאבש תופורתה רגאמב
ןתינ
לבקל
ולע
הלא םינ
ספדומ
םי
לע
ינפ ידי
ה
הרישי
:םושיר

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
HALAVEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg
eribulin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HALAVEN is indicated for the treatment of adult patients with locally
advanced or metastatic breast
cancer who have progressed after at least one chemotherapeutic regimen
for advanced disease (see
section 5.1). Prior therapy should have included an anthracycline and
a taxane in either the adjuvant or
metastatic setting unless patients were not suitable for these
treatments.
HALAVEN is indicated for the treatment of adult patients with
unresectable liposarcoma who have
received prior anthracycline containing therapy (unless unsuitable)
for advanced or metastatic disease
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
HALAVEN should only be prescribed by a qualified physician experienced
in the appropriate use of
anti-cancer therapy. It should be administered by an appropriately
qualified healthcare professional
only.
Posology
The recommended dose of eribulin as the ready to use solution is 1.23
mg/m
2
which should be
administered intravenously over 2 to 5 minutes on Days 1 and 8 of
every 21-day cycle.
PLEASE NOTE:
In Israel and EU the recommended dose refers to the base of the active
substance (eribulin). Calculation
of the individual dose to be administered to a patient must be based
on the strength of the ready to use
solution that contains 0.44 mg/ml eribulin and the dose recommendation
of 1.23 mg/m
2
. The dose
reduction recommendations shown below are also shown as the dose of
eribulin to be administered
based on the strength of the ready to use solution.
In the pivotal trials, the corresponding publications and in some
other regions e.g. the United States and
Switzerland, the recommended dos