Fasenra

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Benralizumab

זמין מ:

AstraZeneca AB

קוד ATC:

R03DX10

INN (שם בינלאומי):

benralizumab

קבוצה תרפויטית:

Drugs for obstructive airway diseases,

איזור תרפויטי:

Asthma

סממני תרפויטית:

Fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.

leaflet_short:

Revision: 13

מצב אישור:

Authorised

תאריך אישור:

2018-01-08

עלון מידע

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FASENRA 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
benralizumab
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fasenra is and what it is used for
2.
What you need to know before you use Fasenra
3.
How to use Fasenra
4.
Possible side effects
5.
How to store Fasenra
6.
Contents of the pack and other information
1.
WHAT FASENRA IS AND WHAT IT IS USED FOR
WHAT FASENRA IS
Fasenra contains the active substance benralizumab, which is a
monoclonal antibody, a type of protein
that recognises and attaches to a specific target substance in the
body. The target of benralizumab is a
protein called interleukin-5 receptor, which is found particularly on
a type of white blood cell called an
eosinophil.
WHAT FASENRA IS USED FOR
Fasenra is used to treat SEVERE EOSINOPHILIC ASTHMA in adults.
Eosinophilic asthma is a type of asthma
where patients have too many eosinophils in the blood or lungs.
Fasenra is used together with other medicines to treat asthma (high
doses of ‘corticosteroid inhalers’
plus other asthma medicines) when the disease is not well controlled
by those other medicines alone.
HOW FASENRA WORKS
Eosinophils are white blood cells involved in asthma inflammation. By
attaching to the eosinophils,
Fasenra helps to reduce their numbers and inflammation.
WHAT ARE THE BENEFITS OF USING FASENRA
Fasenra may reduce the number of asthma attacks you are experiencing,
help you breathe better and
decrease your asthma

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fasenra 30 mg solution for injection in pre-filled syringe
Fasenra 30 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringe
Each pre-filled syringe contains 30 mg benralizumab* in 1 mL.
Pre-filled pen
Each pre-filled pen contains 30 mg benralizumab* in 1 mL.
*Benralizumab is a humanised 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 (injection) in pre-filled syringe
Solution for injection (injection) in pre-filled pen (Fasenra Pen)
Clear to opalescent, colourless to yellow solution and may contain
translucent or white to off-white
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fasenra is indicated as an add-on maintenance treatment in adult
patients with severe eosinophilic
asthma inadequately controlled despite high-dose inhaled
corticosteroids plus long-acting β-agonists
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fasenra treatment should be initiated by a physician experienced in
the diagnosis and treatment of
severe asthma.
After proper training in the subcutaneous injection technique and
education about signs and symptoms
of hypersensitivity reactions (see section 4.4), patients with no
known history of anaphylaxis or their
caregivers may administer Fasenra if their physician determines that
it is appropriate, with medical
follow-up as necessary. Self-administration should only be considered
in patients already experienced
with Fasenra treatment.
Posology
The recommended dose of benralizumab is 30 mg by subcutaneous
injection every 4 weeks for the
first 3 doses, and then every 8 weeks thereafter. If an injection is
missed on the planned date, dosing
should resume as soon as possible on the indicated regimen; a double
dose must not be administered.
3
Fasenra is intended for long-term treatment. A decis