FASENRA benralizumab 30 mg in 1 mL solution for injection prefilled syringe

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

benralizumab, Quantity: 30 mg

Dostupné z:

AstraZeneca Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

Excipient Ingredients: polysorbate 20; trehalose; histidine; histidine hydrochloride monohydrate; water for injections

Spôsob podávania:

Subcutaneous

Počet v balení:

1

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

FASENRA is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count greater than or equal to 300 cells/microlitre or greater than or equal to 150 cells/microlitre if on oral corticosteroid treatment) (see Section 5.1 Pharmacodynamic properties [Clinical Trials]).

Prehľad produktov:

Visual Identification: FASENRA is a clear to opalescent, colourless to yellow solution for injection in a prefilled syringe.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2018-04-02

Príbalový leták

Fasenra® prefilled syringe and Fasenra Pen™
1
FASENRA® PREFILLED SYRINGE AND FASENRA PEN™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING FASENRA?
FASENRA contains the active ingredient benralizumab. FASENRA is used
to treat a type of asthma - eosinophilic asthma – in adults
and children aged 12 years and over.
For more information, see Section 1. Why am I using FASENRA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FASENRA?
Do not use if you have ever had an allergic reaction to FASENRA or any
of the ingredients listed at the end of the CMI.
Do not use to treat acute asthma symptoms such as a sudden asthma
attack. You will still need your reliever puffer/inhaler.
Tell your doctor if you have, or have had, an infection caused by
parasites (eg parasitic worms) or if you live in/are travelling to an
area where parasitic infections are common.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
FASENRA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FASENRA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW FASENRA IS GIVEN?
Your doctor or nurse may have recommended that you/your caregiver can
give your subcutaneous (under the skin) injection, or it
may be given to you by a healthcare professional.
The recommended dose is 30 mg (one injection - as either FASENRA PEN
or FASENRA prefilled syringe) every 4 weeks for the first
3 doses, then one injection every 8 weeks after that.
Continue FASENRA for as long as your doctor tells you
More instructions can be found

Súhrn charakteristických

1 of 18
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at
www.tga.gov.au/reporting-problems
.
AUSTRALIAN PRODUCT INFORMATION
FASENRA
® (BENRALIZUMAB) SOLUTION FOR INJECTION
PREFILLED SYRINGE AND PREFILLED PEN (FASENRA PEN™)
1
NAME OF THE MEDICINE
Benralizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FASENRA prefilled syringe contains 30 mg benralizumab in 1 mL (30
mg/mL).
Each FASENRA PEN prefilled pen contains 30 mg benralizumab in 1 mL (30
mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
Clear to opalescent, colourless to yellow solution for injection in a
prefilled syringe (FASENRA) or
prefilled pen (FASENRA PEN).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FASENRA is indicated as add-on therapy in patients aged 12 years and
over with severe
eosinophilic asthma (blood eosinophil count ≥300 cells/µL or ≥150
cells/µL if on oral
corticosteroid treatment) (see Section 5.1 Pharmacodynamic properties
[
_Clinical Trials_
]).
4.2
DOSE AND METHOD OF ADMINISTRATION
FASENRA should be prescribed by a health care professional in
consultation with a specialist
physician experienced in the diagnosis and treatment of severe asthma.
Treatment with high-dose
inhaled corticosteroids (ICS) and long-acting β-agonists (LABA)
should be optimised prior to
commencement of treatment with FASENRA.
ADULTS AND ADOLESCENTS (12 YEARS AND OVER)
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.
If an injection is missed on a planned date, dosing should resume as
soon as possible on the
indicated regime; a double dose must not be administered.
FASENRA is intended for long-term treatment. A decision to continue
therapy should be made at
least annually based on disease severity and level of exacerbatio