Cablivi

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Caplacizumab

Dostupné z:

Ablynx NV

ATC kód:

B01A

INN (Medzinárodný Name):

caplacizumab

Terapeutické skupiny:

Antithrombotic agents

Terapeutické oblasti:

Purpura, Thrombotic Thrombocytopenic

Terapeutické indikácie:

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

Prehľad produktov:

Revision: 8

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2018-08-30

Príbalový leták

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
CABLIVI 10 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
caplacizumab
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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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 Cablivi is and what it is used for
2.
What you need to know before you use Cablivi
3.
How to use Cablivi
4.
Possible side effects
5.
How to store Cablivi
6.
Contents of the pack and other information
1.
WHAT CABLIVI IS AND WHAT IT IS USED FOR
Cablivi contains the active substance caplacizumab. It is used to
treat an episode of
ACQUIRED
THROMBOTIC THROMBOCYTOPENIC PURPURA
in adults and adolescents of 12 years of age and older
weighing at least 40 kg. This is a rare blood clotting disorder in
which clots form in small blood
vessels. These clots can 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CABLIVI
DO NOT USE CABLIVI
•
if you are allergic to caplacizumab or any of the other ingredients in
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Tell your doctor if you:
•
bleed excessively or experience unusual symptoms such as headache,
shortness of breath,
tiredness, or fainting which may indicate serious internal bleeding.
Your doctor may ask you to
stop the treatment. The doctor will say when you can start your
treatm

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cablivi 10 mg powder and solvent for solution for injection
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.
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 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.
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.
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 of ADAMTS13 activity level).
3
In the clinical development program, caplacizumab has been
administered daily for up to 71 days
consecutively. Data on re-treatment with caplacizumab are available
(see section 5.1).
_Missed dose _