Takhzyro

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

lanadelumab

Disponibil de la:

Takeda Pharmaceuticals International AG Ireland Branch

Codul ATC:

B06AC05

INN (nume internaţional):

lanadelumab

Grupul Terapeutică:

Other hematological agents

Zonă Terapeutică:

Angioedemas, Hereditary

Indicații terapeutice:

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.

Rezumat produs:

Revision: 12

Statutul autorizaţiei:

Authorised

Data de autorizare:

2018-11-22

Prospect

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAKHZYRO 150 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
lanadelumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICATION TO
THE CHILD BECAUSE IT CONTAINS
IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask the child’s doctor,
pharmacist or nurse.
-
This medicine has been prescribed for your child or a child in your
care only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as those of your child or
the child you are caring for.
-
If the child gets any side effects, talk to their doctor, pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TAKHZYRO is and what it is used for
2.
What you need to know before giving TAKHZYRO
3.
How to use TAKHZYRO
4.
Possible side effects
5.
How to store TAKHZYRO
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT TAKHZYRO IS AND WHAT IT IS USED FOR
TAKHZYRO contains the active substance lanadelumab.
WHAT TAKHZYRO IS USED FOR
TAKHZYRO 150 mg is a medicine used in patients 2 years of age and
older weighing less than 40 kg,
to prevent angioedema attacks in patients with hereditary angioedema
(HAE).
WHAT HEREDITARY ANGIOEDEMA (HAE) IS
HAE is a condition which runs in families. With this condition the
patients blood does not have
enough of a protein called ‘C1 inhibitor’, or C1 inhibitor does
not work properly. This leads to too
much ‘plasma kallikrein’, which in turn produces higher levels of
‘bradykinin’ in the bloodstream.
Too much bradykinin leads to symptoms of HAE like swelling and pain on
the,
•
hands and feet
•
face, eyelids, lips or tongue
•
voice-box (larynx), which may make breathing difficult
•
genitals
HOW TAKHZYRO WORKS
TAKHZYRO is a type of protein that blocks the activity of plasma
kallikrein. This helps to reduce the
amount of bradykinin in the bloodstr

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TAKHZYRO 150 mg solution for injection in pre-filled syringe
TAKHZYRO 300 mg solution for injection in pre-filled syringe
TAKHZYRO 300 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAKHZYRO 150 mg solution for injection in pre-filled syringe
One unit (pre-filled syringe) contains 150 mg of lanadelumab* in 1 ml
solution.
TAKHZYRO 300 mg solution for injection (pre-filled syringe or vial)
One unit (pre-filled syringe or vial) contains 300 mg of lanadelumab*
in 2 ml solution.
*
Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
The solution is colourless to slightly yellow, appearing either clear
or slightly opalescent.
The solution has a pH of approximately 6.0 and an osmolality of
approximately 300 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TAKHZYRO is indicated for routine prevention of recurrent attacks of
hereditary angioedema (HAE)
in patients aged 2 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be initiated under the supervision of a
physician experienced in the
management of patients with hereditary angioedema (HAE).
Posology
_Adults and Adolescents 12 to less than 18_
_years of age _
_ _
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In
patients who are stably
attack free on treatment, a dose reduction to 300 mg lanadelumab every
4 weeks may be considered,
especially in patients with low weight.
In patients with a body weight less than 40 kg, a starting dose of 150
mg lanadelumab every 2 weeks
may also be considered. In patients who are stably attack free on
treatment, a dose reduction to 150 mg
lanadelumab every 4 weeks may be considered.
3
_Children 2 to less than 12 years of age _
_ _
The recommended dose of lanadelumab for children 2 to less than 12
years of age is based on body
weight (