XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Omalizumab, Quantity: 150 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Omalizumab

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

Pack containing 10 syringes, Pack containing 4 syringes, Pack containing 1 syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Product summary:

Visual Identification: Clear to opalescent, slightly yellow to brownish-yellow solution for injection; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-08-16

Patient Information leaflet

XOLAIR®
1
XOLAIR
®
_Omalizumab(rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xolair.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or healthcare provider.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Xolair against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT XOLAIR IS USED
FOR
ALLERGIC ASTHMA
Xolair is used to prevent or relieve
the symptoms of allergic asthma in
people who are already using
preventer puffers containing steroids.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to a
reaction to house dust mites, smoke
or other irritants.
This medicine can be used in adults
and in children aged 6 years or over
in allergic asthma.
CHRONIC RHINOSINUSITIS WITH NASAL
POLYPS (NASAL POLYPS)
Xolair is used to treat nasal polyps in
adults (18 years of age and older)
whose severe disease is not well
controlled with their current nasal
polyps medicines. Xolair helps
reduce the size of the polyps and
improves symptoms caused by nasal
polyps including nasal congestion,
loss of sense of smell, post-nasal drip
and runny nose.
This medicine can be used in adults
aged 18 years and over in nasal
polyps. Its use in children and
adolescents below 18 years of age
with nasal polyps has not been

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – XOLAIR
® (OMALIZUMAB)
SOLUTION FOR INJECTION AND POWDER FOR SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Omalizumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omalizumab is a recombinant DNA-derived humanised monoclonal antibody
produced in Chinese
hamster ovary cells that selectively binds to human immunoglobulin E
(IgE).
Solution for injection in pre-filled syringe
Each pre-filled syringe of 0.5 mL contains 75 mg of omalizumab.
Each pre-filled syringe of 1 mL contains 150 mg of omalizumab.
Powder for injection vial with diluent for solution for injection
One vial of Xolair® 75 mg powder for injection contains 75mg of
omalizumab. A reconstituted single
use vial delivers 75 mg omalizumab per 0.6 mL (125 mg/mL).
One vial of Xolair® 150 mg powder for injection contains 150 mg of
omalizumab. A reconstituted single
use vial delivers 150mg omalizumab per 1.2 mL (125 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear to slightly opalescent, colourless to pale brownish-yellow
preservative free solution in a pre-
filled syringe.
Powder for injection vial with diluent
Xolair is a sterile, white, preservative free lyophilised powder that
is reconstituted with water for
injections and administered as a subcutaneous (SC) injection.
Powder: white to off-white lyophilizate in a glass vial.
Diluent: clear and colourless solution in a glass ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ALLERGIC ASTHMA
_Children 6 to < 12 years of age _
2
In children aged 6 to <12 years, Xolair is indicated as add-on therapy
to improve asthma control in
patients with severe allergic asthma who have documented exacerbations
despite daily high dose
inhaled corticosteroids, and who have immunoglobulin E levels
corresponding to the recommended
dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF
ADMINISTRATION).
_Adults and adolescents ≥ 12 years of age _
Xolair is indicated for the ma