CABLIVI caplacizumab 10 mg powder for injection and diluent pre-filled syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

caplacizumab, Quantity: 10 mg

Disponibil de la:

Sanofi-Aventis Australia Pty Ltd

Forma farmaceutică:

Injection, powder for

Compoziție:

Excipient Ingredients:

Calea de administrare:

Subcutaneous, Intravenous

Unități în pachet:

7, 1

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

Rezumat produs:

Visual Identification: Powder and solvent for solution for injection.,White lyophilised powder.,The solvent is a clear, colourless liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2020-02-05

Prospect

CABLIVI™
C
A
B
L
I
V
I
™
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 or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING CABLIVI?
Cablivi contains the active ingredient caplacizumab. Cablivi is used
to treat an episode of acquired thrombotic thrombocytopenic
purpura (aTTP).
For more information, see Section 1. Why am I using Cablivi? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CABLIVI?
Do not use if you have ever had an allergic reaction to caplacizumab
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
Cablivi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cablivi 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 CABLIVI?
•
Treatment with Cablivi is started by a doctor experienced in blood
disorders, before plasma exchange treatment begins.
•
Subsequent doses will be given after each daily plasma exchange and
then for at least 30 days after plasma exchange
treatment has finished.
•
If your doctor decides you or your caregiver can inject Cablivi, they
will train you on how to do so safely.
More instructions can be found in Section 4. How do I use Cablivi? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CABLIVI?
THINGS YOU
SHOULD DO
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are using this medicine
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cablivi.
THINGS YOU
SHOULD NOT DO
•
Do not use Cablivi if you think that it has been frozen or exposed to
temperatures abov

Caracteristicilor produsului

cablivi-ccdsv5-piv4-19jan23
Page 1 of 16
▼
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 – CABLIVI (CAPLACIZUMAB)
1
NAME OF THE MEDICINE
Caplacizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 10 mg of caplacizumab*.
Each pre-filled syringe of solvent contains 1 mL of water for
injections.
* Caplacizumab is a humanised bivalent Nanobody produced in
_Escherichia coli_
by recombinant
DNA technology.
For the full list of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White lyophilised powder.
The solvent is a clear, colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cablivi is indicated for the treatment of adults experiencing an
episode of acquired thrombotic
thrombocytopenic purpura (aTTP), in conjunction with plasma exchange
and immunosuppression.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with Cablivi should be initiated and supervised by
physicians experienced in the
management of patients with thrombotic microangiopathies.
cablivi-ccdsv5-piv4-19jan23
Page 2 of 16
POSOLOGY
_FIRST DOSE _
Intravenous injection of 10 mg of caplacizumab prior to plasma
exchange.
_SUBSEQUENT DOSES _
Daily subcutaneous administration of 10 mg of caplacizumab after
completion of each plasma
exchange for the duration of daily plasma exchange treatment, followed
by daily subcutaneous
injection of 10 mg of caplacizumab for 30 days after stopping daily
plasma exchange treatment.
If at the end of this period there is evidence of unresolved
immunological disease, it is
recommended to optimise the immunosuppression regimen and continue
daily subcutaneous
administration of 10 mg of caplacizumab until the signs of underlying
immunological disease are
resolved (e.g. sustained normalisation o