Fasenra 30 mg solution for injection in pre-filled syringe

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BENRALIZUMAB

Available from:

ASTRAZENECA SDN. BHD.

INN (International Name):

BENRALIZUMAB

Units in package:

1 ml

Manufactured by:

Amylin Ohio LLC

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FASENRA
®
30mg Solution for Injection in Pre-filled Syringe
_ _
1
WHAT IS IN THIS LEAFLET
1.
What FASENRA is used for
2.
How FASENRA works
3.
Before you use FASENRA
4.
How to use FASENRA
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
FASENRA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT FASENRA
IS USED FOR
FASENRA is used to treat severe
eosinophilic asthma in adults from
18 years. 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 (inhaled
corticosteroids plus other asthma
medicines).
HOW FASENRA
WORKS
FASENRA helps prevent severe
asthma attacks (exacerbations)
and may improve your breathing.
Medicines such as FASENRA
reduce blood eosinophils.
Eosinophils are a type of white
blood cell that may contribute to
your asthma by causing
inflammation in the lungs.
BEFORE YOU USE FASENRA_ _
_- When you must not use it: _
Do not use FASENRA
•
If you are allergic to
benralizumab or any of the
other ingredients of this
medicine (listed in ingredients).
Check with your doctor, nurse
or pharmacist if you think this
applies to you.
_- Before you start to use it _
Before you use FASENRA, tell
your doctor, nurse or pharmacist:
•
If you have had any symptoms
of an allergic reaction (see
section ‘side effects’). Allergic
reactions have occurred in
patients receiving this
medicine.
•
If you have a parasitic infection
or if you live in an area where
parasitic infections are common
or if you are travelling to such
region, as this medicine may
weaken your ability to fight
certain types of parasitic
infections.
_- Taking other medicines _
Please tell your doctor or
pharmacist if you are using, have
recently used or might use any
other medicines.
Do not suddenly stop taking or
change the dose of your preventer
medicines for your asthma once
you have started FASENRA.
These medicines (especially

Summary of Product characteristics

1 (18)
FASENRA
®
30MG / 1ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE
benralizumab
1.
NAME OF THE MEDICINAL PRODUCT
FASENRA 30mg / 1mL Solution for Injection in Prefilled Syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled syringe contains 30 mg benralizumab in 1 mL.
Benralizumab is a humanised, afucosylated, monoclonal antibody
selective for interleukin-5Rα.
Benralizumab is of the IgG1/κ-class produced in Chinese hamster ovary
(CHO) cells by
recombinant DNA technology.
Benralizumab has a molecular weight of approximately 150 kDa.
3.
PHARMACEUTICAL FORM
Solution for injection in prefilled syringe (injection).
The solution is a clear to opalescent, colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
FASENRA is indicated as an add-on maintenance treatment in adult
patients from 18 years with
severe eosinophilic asthma characterised by the following criteria:
•
At least two exacerbations in the past 12 months on the current
standard therapy (high-dose
inhaled corticosteroids plus long-acting bronchodilators) and/or need
for treatment with
systemic corticosteroids.
•
Eosinophil count in the blood of ≥0.3 G/L (corresponding to ≥300
cells/μL).
For detailed information about the patient populations investigated in
trials, please see “Clinical
Efficacy”.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fasenra treatment should be initiated by a physician experienced in
the diagnosis and treatment of
severe asthma.
Posology
The recommended dose is 30 mg of FASENRA by subcutaneous injection
every 4 weeks for the
first 3 doses, and then every 8 weeks thereafter.
Fasenra is intended for long-term treatment. A decision to continue
the therapy should be made at
least annually based on disease severity, level of exacerbation
control and blood eosinophil counts.
2 (18)
_Paediatric population _
The safety and efficacy of FASENRA in children aged 6 to 18 years have
not been established.
No data are available for children aged 6 to 11 years old. Currently
available data in chi