CABLIVI

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CAPLACIZUMAB

Tilgængelig fra:

SANOFI ISRAEL LTD

ATC-kode:

B01AX07

Lægemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammensætning:

CAPLACIZUMAB 10 MG/VIAL

Indgivelsesvej:

S.C, I.V

Recept type:

Required

Fremstillet af:

ABLYNX NV., BELGIUM

Terapeutisk område:

CAPLACIZUMAB

Terapeutiske indikationer:

CABLIVI is indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

Autorisation dato:

2020-08-23

Indlægsseddel

70106v01
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with
a doctor’s prescription only
CABLIVI 10 MG
Powder and solvent for solution for subcutaneous/
intravenous injection
ACTIVE INGREDIENT: each powder vial contains caplacizumab 10 mg
Inactive and allergenic ingredients in the preparation: see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine.
If you have any further questions, consult your doctor, pharmacist or
nurse.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is similar to yours.
IN ADDITION TO THE PATIENT INFORMATION LEAFLET, CABLIVI ALSO HAS
A PATIENT SAFETY INFORMATION CARD. THIS CARD CONTAINS IMPORTANT
SAFETY INFORMATION THAT YOU NEED TO KNOW AND THAT YOU SHOULD
FOLLOW BEFORE YOU START TREATMENT AND DURING THE TREATMENT WITH
CABLIVI. CAREFULLY READ THE PATIENT SAFETY INFORMATION CARD AND
PATIENT INFORMATION LEAFLET BEFORE USING THIS MEDICINE. KEEP THE
CARD IN CASE YOU NEED TO READ IT AGAIN.
1. WHAT CABLIVI IS INTENDED FOR?
Cablivi is indicated for the treatment of adults suffering from
acquired
thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma
exchange and immunosuppression.
aTTP is a rare blood clotting disorder in which clots form in small
blood
vessels. These blood clots may block blood vessels and damage the
brain,
heart, kidneys, or other organs. Cablivi prevents the formation of
these
blood clots by stopping platelets in the blood from clumping together.
By doing so, Cablivi reduces the risk of experiencing another episode
of
aTTP soon after the first episode.
THERAPEUTIC GROUP: antithrombotic agents.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
if you are sensitive (allergic) to caplacizumab or any of the other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
T

Produktets egenskaber

1
_ _
_Version: CABL‐INJ‐10mg‐SPC‐5.0 _
1.
NAME OF THE MEDICINAL PRODUCT
Cablivi
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.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection S.C, IV.
White lyophilised powder.
The solvent is a clear, colourless liquid.
PATIENT SAFETY INFORMATION CARD
The marketing of Cablivi is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The Patient safety information card' emphasizes
important safety information that
the patient should be aware of before and during treatment. Please
explain to the patient the need to
review the card before starting treatment.
_ _
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
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Cablivi should be initiated and supervised by
physicians experienced in the
management of patients with thrombotic microangiopathies.
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.
2
If after initial treatment course, sign(s) of persistent underlying
disease such as suppressed
ADAMTS13 activity levels remain present, treatment may be extended for
a maximum of 28 days.
In the clinical development program, caplacizumab has been
administered daily for up to