Vyxeos liposomal (previously known as Vyxeos)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

daunorubicin hydrochloride, cytarabine

Available from:

Jazz Pharmaceuticals Ireland Limited

ATC code:

L01XY01

INN (International Name):

daunorubicin, cytarabine

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Myeloid, Acute

Therapeutic indications:

Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2018-08-23

Patient Information leaflet

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VYXEOS LIPOSOMAL
44 MG/100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
daunorubicin and cytarabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Vyxeos liposomal is and what it is used for
2.
What you need to know before you are given Vyxeos liposomal
3.
How you are given Vyxeos liposomal
4.
Possible side effects
5.
How to store Vyxeos liposomal
6.
Contents of the pack and other information
1.
WHAT VYXEOS LIPOSOMAL IS AND WHAT IT IS USED FOR
WHAT VYXEOS LIPOSOMAL IS
Vyxeos liposomal belongs to a group of medicines called
‘antineoplastics’ used in cancer. It contains
two active substances, called ‘daunorubicin’ and ‘cytarabine’,
in the form of tiny particles known as
‘liposomes’.
These active substances act in different ways to kill cancer cells by
stopping them from growing and
dividing. Packaging them in liposomes prolongs their action in the
body and helps them to enter and
kill the cancer cells.
WHAT VYXEOS LIPOSOMAL IS USED FOR
Vyxeos liposomal is used to treat patients with newly diagnosed acute
myeloid leukaemia (a cancer of
the white blood cells). It is given when the leukaemia was caused by
previous treatments (known as
therapy related acute myeloid leukaemia) or when there are certain
changes in the bone marrow
(known as acute myeloid leukaemia with “myelodysplasia-related
changes”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VYXEOS LIPOSOMAL
_ _
YOU MUST NOT BE GIVEN VYXEOS LIPOSOMAL
•
if you are allergic to the active substances (daunorubicin or
cytarabine) or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AN

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for solution for infusion contains
44 mg of daunorubicin and
100 mg of cytarabine.
After reconstitution, the solution contains 2.2 mg/mL daunorubicin and
5 mg/mL cytarabine
encapsulated in liposomes in a fixed combination in a 1:5 molar ratio.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Purple, lyophilised cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vyxeos liposomal is indicated for the treatment of adults with newly
diagnosed, therapy-related acute
myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes
(AML-MRC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vyxeos liposomal treatment should be initiated and monitored under the
supervision of a physician
experienced in the use of chemotherapeutic medicinal products.
Vyxeos liposomal has a different posology than daunorubicin injection
and cytarabine injection and it
must not be interchanged with other daunorubicin and/or cytarabine
containing products (see section
4.4).
Posology
Vyxeos liposomal dosing is based on the patient’s body surface area
(BSA) according to the following
schedule:
TABLE 1: DOSE AND SCHEDULE FOR VYXEOS LIPOSOMAL
THERAPY
DOSING SCHEDULE
FIRST INDUCTION
daunorubicin 44 mg/m
2
and cytarabine 100 mg/m
2
on days 1, 3, and 5
SECOND INDUCTION
daunorubicin 44 mg/m
2
and cytarabine 100 mg/m
2
on days 1 and 3
CONSOLIDATION
daunorubicin 29 mg/m
2
and cytarabine 65 mg/m
2
on days 1 and 3
3
_Recommended dosing schedule for induction of remission _
The recommended dosing schedule of Vyxeos liposomal 44 mg/100 mg/m
2
, administered
intravenously over 90 minutes:
•
on days 1, 3, and 5 as the first course of induction therapy.
•
on days 1 and 3 as subsequent course of induction therapy, if needed.
A subsequent cou