Fasenra 30mg Solution for Injection in Pre-filled Pen

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:

AstraZeneca Pharmaceuticals LP

Patient Information leaflet

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FASENRA
®
30mg Solution for Injection in Pre-filled Pen
_ _
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
10.
Product Registration
Holder
11.
Date of Revision
12.
Serial Number
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 medicine

Summary of Product characteristics

1 (18)
FASENRA
®
30MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
benralizumab
1.
NAME OF THE MEDICINAL PRODUCT
FASENRA 30mg Solution for Injection in Pre-filled Pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each autoinjector/pen 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 an autoinjector (injection) (FASENRA PEN)
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 children 12