SARCLISA isatuximab 500 mg/25 mL concentrated injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

isatuximab, Quantity: 500 mg

Prieinama:

Sanofi-Aventis Australia Pty Ltd

Vaisto forma:

Injection, concentrated

Sudėtis:

Excipient Ingredients: water for injections; histidine hydrochloride monohydrate; sucrose; polysorbate 80; histidine

Vartojimo būdas:

Intravenous Infusion

Vienetai pakuotėje:

1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Sarclisa is indicated:,? in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI).,? in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Produkto santrauka:

Visual Identification: A colourless to slightly yellow solution, essentially free of visible particulates; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Registered

Leidimo data:

2020-05-06

Pakuotės lapelis

Sarclisa®
1
SARCLISA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING SARCLISA?
Sarclisa contains the active ingredient isatuximab. Sarclisa is used
to treat “multiple myeloma”. This is a type of cancer of your
bone marrow.
For more information, see Section 1. Why am I using Sarclisa?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SARCLISA?
Do not use if you have ever had an allergic reaction to Sarclisa or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sarclisa?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sarclisa and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE SARCLISA?
Your doctor or nurse will give you Sarclisa into a vein
(intravenously) as a drip infusion.
More instructions can be found in Section 4. How do I use Sarclisa?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SARCLISA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sarclisa.
•
Advise you are using Sarclisa if you have a blood test or blood
infusion.
THINGS YOU
SHOULD NOT DO
•
Do not stop your treatment with Sarclisa unless you have discussed
that with your doctor.
•
Do not take Sarclisa if you are pregnant or planning to become
pregnant.
DRIVING OR USING
MACHINES
•
Sarclisa is not expected to affect your ability to drive or use
machines. However, Sarclisa may cause
dizziness and tiredness in some people.
LOOKING AFTER
YOUR MEDICINE
•
Sarclisa will be stored at the hospital or clinic in

Prekės savybės

sarclisa-ccdsv3-piv2-17sep21
Page 1 of 27
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – SARCLISA
®
(ISATUXIMAB)
1
NAME OF THE MEDICINE
Sarclisa (isatuximab) 20mg/mL concentrated injection for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of Sarclisa concentrated injection contains 20mg isatuximab.
Each single-use vial of
Sarclisa concentrated injection contains 100mg or 500mg isatuximab.
Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody (mAb)
that binds to a
specific extracellular epitope of cluster of differentiation 38 (CD38)
receptor and triggers
several mechanisms leading to the death of CD38 expressing tumor
cells.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated injection for infusion.
Sarclisa is a colourless to slightly yellow solution, essentially free
of visible particulates,
containing no antimicrobial preservatives.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sarclisa is indicated:
-
in combination with pomalidomide and dexamethasone, for the treatment
of patients
with multiple myeloma (MM) who have received at least two prior
therapies
including lenalidomide and a proteasome inhibitor (PI).
-
in combination with carfilzomib and dexamethasone, for the treatment
of patients
with multiple myeloma who have received at least one prior therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Sarclisa should be administered by a healthcare professional, in an
environment where
resuscitation facilities are available.
▼
sarclisa-ccdsv3-piv2-17sep21
Page 2 of 27
PREMEDICATION
Premedication should be used prior to each Sarclisa infusion with the
following medications
to reduce the risk and severity of infusion reactions (IRs):
•
Dexamethasone 40 mg administered orally (PO) or intravenously (IV) (o