TEZSPIRE

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

TEZEPELUMAB

Verfügbar ab:

ASTRAZENECA (ISRAEL) LTD

ATC-Code:

R03DX11

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

TEZEPELUMAB 110 MG/ML

Verabreichungsweg:

S.C

Verschreibungstyp:

Required

Hergestellt von:

ASTRA ZENECA AB, SWEDEN

Therapiebereich:

TEZEPELUMAB

Anwendungsgebiete:

Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Berechtigungsdatum:

2023-01-29

Gebrauchsinformation

Patient Package Leaflet in Accordance With
the Pharmacists’ Regulations (Preparations) – 1986
The medicine is dispensed with a doctor’s prescription only
Tezspire
®
Solution for injection
For subcutaneous injection
Composition:
Each pre-filled pen (1.91 ml) contains:
Tezepelumab 210 mg
For inactive ingredients please refer to Section 6 – “Further
Information”.
Read this leaflet carefully in its entirety before using the medicine.
Keep this leaflet, you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
1)
What is Tezspire and what is it used for?
Tezspire is indicated as an add-on maintenance treatment of adult and
pediatric patients
aged 12 years and older with severe asthma.
Therapeutic group
Medicines to treat narrowing of the airways.
Anti-TSLP (thymic stromal lymphopoietin) monoclonal antibody.
What Tezspire is
Tezspire is a medicine contains the active substance tezepelumab,
which is a
monoclonal antibody. Antibodies are proteins that recognise and bind
to a specific target
substance in the body, which in the case of tezepelumab is a protein
called TSLP
(thymic stromal lymphopoietin). TSLP plays a key role in causing the
inflammation in
your airways that leads to the signs and symptoms of asthma. By
blocking the action of
TSLP, this medicine helps to reduce inflammation and asthma symptoms.
2) Before using the medicine
Do not use the medicine if:
•
you are hypersensitive (allergic) to Tezepelumab or any of the other
ingredients of
this medicine (detailed in section 6). Check with a doctor, nurse or
pharmacist if
you are not sure or think it may be relevant to you.
Special warnings regarding use of Tezspire:
•
Tezspire is not a rescue medicine. Do not use it to treat a sudden
asthma attack.
•
If your asthma is not getting any b

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Tezspire 210 mg solution for injection in pre-filled syringe
Tezspire 210 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringe
Each pre-filled syringe contains 210 mg tezepelumab in 1.91 mL
solution (110 mg/mL).
Pre-filled pen
Each pre-filled pen contains 210 mg tezepelumab in 1.91 mL (110
mg/mL).
Tezepelumab is a human monoclonal antibody 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 in pre-filled syringe (injection)
Solution for injection in pre-filled pen (injection)
Clear to opalescent, colourless to light yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEZSPIRE is indicated for the add-on maintenance treatment of adult
and pediatric patients aged 12
years and older with severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by physicians experienced in the
diagnosis and treatment of severe
asthma.
Posology
_Adults and adolescents (aged 12 years and older) _
The recommended dose is 210 mg of tezepelumab by subcutaneous
injection every 4 weeks.
_Missed dose _
If a dose is missed, the dose should be administered as soon as
possible. Thereafter, the patient can
resume dosing on the scheduled day of administration. If the next dose
is already due, then administer
as planned. A double dose must not be administered.
2
Special populations
_Elderly (≥65 years of age) _
No dose adjustment is required for elderly patients (see section 5.2).
_Renal and hepatic impairment _
No dose adjustment is required for patients with renal or hepatic
impairment (see section 5.2).
_Paediatric population _
The safety and efficacy of Tezspire in children under 12 years of age
have not been established. No
data are available.
Method of administration
Tezspire is administered as a subcutaneous injection.
A patient may self-inject or the patient’s caregiver may administe