Halaven

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Eribulin

Available from:

Eisai GmbH

ATC code:

L01XX41

INN (International Name):

eribulin

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Breast Neoplasms; Liposarcoma

Therapeutic indications:

Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane 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).

Product summary:

Revision: 29

Authorization status:

Authorised

Authorization date:

2011-03-17

Patient Information leaflet

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
HALAVEN 0.44 MG/ML SOLUTION FOR INJECTION
eribulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What HALAVEN is and what it is used for
2.
What you need to know before you use HALAVEN
3.
How to use HALAVEN
4.
Possible side effects
5.
How to store HALAVEN
6.
Contents of the pack and other information
1.
WHAT HALAVEN IS AND WHAT IT IS USED FOR
HALAVEN contains the active substance eribulin and is an anti-cancer
medicine which works by
stopping the growth and spread of cancer cells.
It is used in adults for locally advanced or metastatic breast cancer
(breast cancer that has spread
beyond the original tumour) when at least one other therapy has been
tried but has lost its effect.
It is also used in adults for advanced or metastatic liposarcoma (a
type of cancer that arises from fat
tissue) when previous therapy has been tried but has lost its effect.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HALAVEN
DO NOT USE HALAVEN:
-
if you are allergic to eribulin mesilate or any of the other
ingredients of this medicine (listed in
section 6).
-
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using HALAVEN:
-
if you have liver problems
-
if you have a fever or an infection
-
if you experience numbness, tingling, prickling sensations,
sensitivity to touch or muscle
weakness
-
if you have heart problems
If any of these affects you, tell your doctor who may wish to stop
treatment or reduce the dose.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children between the ages of 0 to 18
years because it does not work.
OTHER MEDICINES AND HALAVEN
28
Tell your doctor if y

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HALAVEN 0.44 mg/ml solution for injection
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 (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 the 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 a