Empliciti

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Elotuzumab

Dostupné z:

Bristol-Myers Squibb Pharma EEIG

ATC kód:

L01FX08

INN (Medzinárodný Name):

elotuzumab

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Multiple Myeloma

Terapeutické indikácie:

Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).

Prehľad produktov:

Revision: 12

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2016-05-11

Príbalový leták

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMPLICITI 300 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
EMPLICITI 400 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
elotuzumab
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 pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Empliciti is and what it is used for
2.
What you need to know before you use Empliciti
3.
How to use Empliciti
4.
Possible side effects
5.
How to store Empliciti
6.
Contents of the pack and other information
1.
WHAT EMPLICITI IS AND WHAT IT IS USED FOR
Empliciti contains the active substance elotuzumab, which is a
monoclonal antibody, a type of protein
designed to recognise and attach to a specific target substance in the
body. Elotuzumab attaches to a
target protein called SLAMF7. SLAMF7 is found in large amounts on the
surface of multiple
myeloma cells and on certain cells of your immune system (natural
killer cells). When elotuzumab
binds to SLAMF7 on the multiple myeloma or natural killer cells, it
stimulates your immune system to
attack and destroy the multiple myeloma cells.
Empliciti is used to treat multiple myeloma (a cancer of the bone
marrow) in adults. Empliciti will be
given to you together with lenalidomide and dexamethasone or together
with pomalidomide and
dexamethasone. Multiple myeloma is a cancer of a type of white blood
cell called plasma cells. These
cells divide out of control and collect in the bone marrow. This
results in damage to the bones and
kidneys.
Empliciti is used if your cancer has not responded to, or has come
back after certain treatments.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EMPLICITI
YOU SHOULD NOT BE GIVEN EMPLICITI

if you are allergic t

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Empliciti 300 mg powder for concentrate for solution for infusion.
Empliciti 400 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Empliciti 300 mg powder for concentrate for solution for infusion
Each vial of powder contains 300 mg elotuzumab*.
Empliciti 400 mg powder for concentrate for solution for infusion
Each vial of powder contains 400 mg elotuzumab.
After reconstitution, each mL of concentrate contains 25 mg
elotuzumab.
* Elotuzumab is produced in NS0 cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
The powder is white to off white whole or fragmented cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Empliciti is indicated in combination with lenalidomide and
dexamethasone for the treatment of
multiple myeloma in adult patients who have received at least one
prior therapy (see sections 4.2
and 5.1).
Empliciti is indicated in combination with pomalidomide and
dexamethasone for the treatment of
adult patients with relapsed and refractory multiple myeloma who have
received at least two prior
therapies including lenalidomide and a proteasome inhibitor and have
demonstrated disease
progression on the last therapy (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Elotuzumab therapy should be initiated and supervised by physicians
experienced in the treatment of
multiple myeloma.
Premedication for prevention of infusion related reactions (IRRs)
Patients must be administered with the following premedications 45-90
minutes prior to Empliciti
infusion (see section 4.4):

Dexamethasone 8 mg intravenous

H1 blocker: diphenhydramine (25-50 mg orally or intravenous) or
equivalent H1 blocker.

H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or
equivalent H2 blocker.

Paracetamol (650-1000 mg orally).
Management