EMPLICITI 300 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ELOTUZUMAB

Available from:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC code:

L01XC23

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ELOTUZUMAB 300 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BRISTOL-MYERS SQUIBB HOLDINGS PHARMA, LTD. LIABILITY COMPANY, PUERTO RICO

Therapeutic area:

ELOTUZUMAB

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.Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment ofadult patients with relapsed and refractory multiple myeloma who have received at least two priortherapies, including lenalidomide and a proteasome inhibitor, and have demonstrated diseaseprogression on the last therapy.

Authorization date:

2021-08-31

Patient Information leaflet

1
689IL1906365-02
רבמטפס
2019
Empliciti (elotuzumab) 300 mg & 400mg
Powder for concentrate for solution for infusion
אפור
/
ה
,
חקור
/
ת
רקי
/
,ה
וננוצרב
ךעידוהל
לע
ןוכדע
ןולעב
אפורל
לש
רישכתה
יטיסילפמא
)
elotuzumab
(
לארשיב
.
:ב"השמ י"ע ורשואש יפכ רישכתה תויוותה
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.
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.
טוריפב
ןלהלש
םילולכ
םינוכדעה
םייתוהמה
ןמוסמ ףסונש טסקט) דבלב
םודא עבצב
רסוהש טסקט,ןותחת וקבו
םודא עבצב ןמוסמ
יעצמא וקבו
.(
.תואירבה דרשמ ידי לע רשואש יפכ אפורל
ןולעב ןייעל שי הפורתה לע אלמ עדימל
ןולעה
לעבל היינפ ידי לע ספדומ ולבקל ןתינו
תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל חלשנ אפורל
לוטסירב םושירה
-
מ"עב (לארשי) ביווקס סרייאמ
.
,בר דובכב
,הרואלק ןריש
הנוממ תחקור
2
:אפורל ןולעב םייתוהמ םינוכדע
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 len

Summary of Product characteristics

Empliciti_NPI_July 2022
EMPLICITI 300 MG
EMPLICITI 400 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR IV INFUSION
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.
Empliciti_NPI_July 2022
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 15