EMPLICITI elotuzumab 400mg lyophilized powder for IV infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

elotuzumab, Quantity: 440 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

elotuzumab

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections

Administration route:

Intravenous Infusion

Units in package:

1 vial per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EMPLICITI (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Product summary:

Visual Identification: A nonpyrogenic lyophilized powder that is a white to off-white, whole or fragmented cake; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-09-22

Patient Information leaflet

EMPLICITI
®
_(EM-PLI-SEE-TEE)_
_Elotuzumab (elo tu zu mab)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking EMPLICITI. This leaflet
answers some common questions
about EMPLICITI.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking EMPLICITI
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT EMPLICITI 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 Signaling Lymphocyte
Activation Molecule Family
member 7 (SLAMF7). SLAMF7 is
found in large amounts on the surface
of some cancer cells (multiple
myeloma cells) and on certain cells
of your immune system (natural
killer cells).
When elotuzumab binds to SLAMF7
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 in combination
with other medicines.
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 one or more other types
of treatment before.
EMPLICITI is not recommended for
use in children and people under
18 years.
Ask your doctor if you have any
questions about why EMPLICITI has
been prescribed for you.
EMPLICITI is not addictive. This
medicine is available only with a
doctor's prescription.
BEFORE YOU ARE GIVEN
EMPLICITI
IT IS IMPORTANT THAT YOU READ THE
INFORMATION BELOW AND TALK TO YOUR
DOCTOR OR NURSE BEFORE YOU ARE
GIVEN EM

Summary of Product characteristics

AU_PI_Empliciti_V4.0
AUSTRALIAN PRODUCT INFORMATION – EMPLICITI
®
(ELOTUZUMAB)
1
NAME OF THE MEDICINE
Elotuzumab.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EMPLICITI 300 mg powder for concentrate for solution for intravenous
infusion.
EMPLICITI 400 mg powder for concentrate for solution for intravenous
infusion.
Each vial contains either 300 mg or 400 mg elotuzumab. After
reconstitution, each mL of concentrate
contains 25 mg elotuzumab.
Elotuzumab is a humanized recombinant monoclonal antibody directed to
SLAMF7, a cell surface
glycoprotein. Elotuzumab consists of the complementary determining
regions (CDR) of the mouse
antibody MuLuc63 grafted onto human IgG1 heavy and kappa light chain
frameworks. Elotuzumab is
produced in NS0 cells by recombinant DNA technology. Purified
elotuzumab IgG1 has been shown to
have an affinity to SLAMF7 in the range of 30 to 45 nM.
EMPLICITI for Injection vials require reconstitution with Sterile
Water for Injection, BP (13 mL and
17 mL, respectively) to obtain a solution with a concentration of 25
mg/mL. After reconstitution, each
vial contains overfill to allow for withdrawal of 12 mL (300 mg) and
16 mL (400 mg). The reconstituted
solution has a pH of 5.7 – 6.3 in sterile water for injection BP and
is intravenously administered as an
isotonic solution upon further dilution with 0.9% sodium chloride or
5% glucose.
Note:
“quantitative composition” only relates to the quantity of the
therapeutically active ingredient.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
EMPLICITI is a nonpyrogenic lyophilized powder that is a white to
off-white, whole or fragmented
cake that is provided in two strengths.
EMPLICITI for Injection, 400 mg per vial and EMPLICITI for Injection,
300 mg per vial are single-
use, sterile, nonpyrogenic lyophilized products.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMPLICITI (elotuzumab) is indicated in combination with lenalidomide
and dexamethasone for the
treatment of patients with multiple myeloma w