Eribulin Advanz Pharma 0.44 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Eribulin mesylate

Available from:

Advanz Pharma Limited

ATC code:

L01XX41

INN (International Name):

Eribulin mesylate

Pharmaceutical form:

Solution for injection

Therapeutic area:

eribulin

Authorization status:

Not marketed

Authorization date:

2023-09-22

Patient Information leaflet

1
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER ERIBULIN ADVANZ PHARMA 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 Eribulin Advanz Pharma
is and what it is used for
2.
What you need to know before you use Eribulin Advanz Pharma
3.
How to use Eribulin Advanz Pharma
4.
Possible side effects
5.
How to store Eribulin Advanz Pharma
6.
Contents of the pack and other information
1.
WHAT ERIBULIN ADVANZ PHARMA IS AND WHAT IT IS USED FOR
Eribulin Advanz Pharma
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 ERIBULIN ADVANZ PHARMA
DO NOT USE ERIBULIN ADVANZ PHARMA:
-
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 Eribulin Advanz Pharma
-
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

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2023
CRN00D48F
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eribulin Advanz Pharma 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 colorless solution free from visible particulate matter, pH 7.0
to 9.2, osmolality 780 to 970 mOsm/Kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eribulin Advanz Pharma 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.
Eribulin Adalvo 0.44 mg/ml solution for Injection 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
Eribulin Advanz Pharma 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.