Empliciti 400mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Elotuzumab

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC code:

L01XC23

INN (International Name):

Elotuzumab

Dosage:

400mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5012712143499

Patient Information leaflet

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
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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. It is used in
combination with lenalidomide 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 when you have already had at least one multiple

Summary of Product characteristics

OBJECT 1
EMPLICITI 300 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 20-Jul-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 contains 300 mg elotuzumab*.
Empliciti 400 mg powder for concentrate for solution for infusion
Each vial 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).
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 reaction
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 of infusi