Mylotarg

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

gemtuzumab ozogamicin

MAH:

Pfizer Europe MA EEIG

ATC_code:

L01XC05

INN:

gemtuzumab ozogamicin

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Leukemia, Myeloid, Acute

therapeutic_indication:

Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

leaflet_short:

Revision: 12

authorization_status:

Authorised

authorization_date:

2018-04-19

PIL

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYLOTARG 5 mg powder for concentrate for solution for infusion
gemtuzumab ozogamicin
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 MYLOTARG is and what it is used for
2.
What you need to know before you are given MYLOTARG
3.
How MYLOTARG will be given
4.
Possible side effects
5.
How to store MYLOTARG
6.
Contents of the pack and other information
1.
What MYLOTARG is and what it is used for
MYLOTARG contains the active substance gemtuzumab ozogamicin, an
anticancer medicine, which is
made up of a monoclonal antibody linked to a substance intended to
kill cancer cells. This substance is
delivered to cancer cells by the monoclonal antibody. A monoclonal
antibody is a protein which recognises
certain cancer cells.
MYLOTARG is used to treat a certain type of blood cancer called acute
myeloid leukaemia (AML) in which
the bone marrow makes abnormal white blood cells. MYLOTARG is intended
for the treatment of AML for
patients aged 15 years and above who have not tried other treatments.
MYLOTARG is not for use in patients
with a type of cancer called acute promyelocytic leukaemia (APL).
2.
What you need to know before you are given MYLOTARG
MYLOTARG should not be given if you:

are allergic to gemtuzumab ozogamicin or any of the other ingredients
of this medicine (listed in
section 6).
Warnings and precautions
When you first receive this medicine and during the course of
treatment, tell your doctor or nurse if you:

have or ever had liver problems: MYLOTARG may cause, during or after
treatment, a potentially
life-threatening condition called hepatic venoocclusive disease, in
which the blood

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MYLOTARG 5 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder for concentrate for solution for infusion contains
5 mg gemtuzumab ozogamicin.
After reconstitution (see section 6.6), the concentrated solution
contains 1 mg/mL gemtuzumab ozogamicin.
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of
the CD33-directed monoclonal
antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa
antibody produced by
mammalian cell culture in NS0 cells) that is covalently linked to the
cytotoxic agent
N-acetyl gamma calicheamicin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white cake or powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
MYLOTARG is indicated for combination therapy with daunorubicin (DNR)
and cytarabine (AraC) for the
treatment of patients aged 15 years and above with previously
untreated, de novo CD33-positive acute
myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL)
(see sections 4.4 and 5.1).
4.2
Posology and method of administration
MYLOTARG should be administered under the supervision of a physician
experienced in the use of
anticancer medicinal products and in an environment where full
resuscitation facilities are immediately
available.
MYLOTARG should be used only in patients eligible to receive intensive
induction chemotherapy.
Premedication with a corticosteroid, antihistamine, and acetaminophen
(or paracetamol) is recommended
1 hour prior to dosing to help ameliorate infusion-related symptoms
(see section 4.4).
Appropriate measures to help prevent the development of tumour
lysis-related hyperuricaemia, such as
hydration, administration of antihyperuricemic or other agents for
treatment of hyperuricaemia should be
taken (see section 4.4).
3
Posology
Induction
The recommended dose of MYLOTAR