Xolair 75mg Powder and Solvent for Solution for Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Omalizumab

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R03DX05

Dosage:

75mg

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Omalizumab 75mg

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2006-07-07

Patient Information leaflet

1 

1. 
NAME OF THE MEDICINAL PRODUCT 

Xolair 75 mg powder and solvent for solution for injection 
Xolair 150 mg powder and solvent for solution for injection 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One vial contains 75 mg or 150mg of omalizumab. Omalizumab is
a humanised monoclonal antibody 
manufactured by recombinant DNA technology in a
Chinese hamster ovary (CHO) mammalian cell 
line. After reconstitution the vial contains
125 mg/ml of omalizumab (75 mg in 0.6 ml or 150 mg in 
1.2 ml). 

For excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Powder and solvent for solution for injection. 

Xolair is an off-white lyophilised powder. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Xolair is indicated as add-on therapy to improve asthma
control in adult and adolescent patients 
(12 years of age and above) with severe persistent allergic asthma
who have a positive skin test or _in _
_vitro_ reactivity to a perennial aeroallergen and who have reduced
lung function (FEV
1
 <80%) as well 
as frequent daytime symptoms or night-time awakenings and who have
had multiple documented 
severe asthma exacerbations despite daily high-dose inhaled
corticosteroids, plus a long-acting 
inhaled beta2-agonist. Xolair treatment should only be considered
for patients with convincing IgE 
mediated asthma (see section 4.2). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Use in adolescents and adults (12 years of age and older) 
Xolair treatment should be initiated and
supervised by specialist physicians experienced in the 
diagnosis and treatment of severe persistent asthma. 

The appropriate dose and dosing frequency of Xolair is determined
by baseline IgE (IU/ml), measured 
before the start of treatment, and body weight (kg). Prior to
initial dosing, patients should have their 
IgE level determined by any commercial

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
XOLAIR
®
75 mg, 150 mg powder and solvent for solution for injection
XOLAIR
®
75 mg, 150 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Xolair 75mg:
One dose (reconstituted) contains 75 mg of omalizumab whereas one vial
(before reconstitution) contains
129.6
mg
of
omalizumab.
Omalizumab
is
a
humanised
monoclonal
antibody
manufactured
by
recombinant
DNA
technology
in
a
Chinese
hamster
ovary
(CHO)
mammalian
cell
line.
After
reconstitution the vial contains 125 mg/ml of omalizumab (75 mg in 0.6
ml).
Xolair 150mg:
One dose (reconstituted) contains 150mg of omalizumab whereas one vial
(before reconstitution) contains
202.5mg
of
omalizumab.
Omalizumab
is
a
humanised
monoclonal
antibody
manufactured
by
recombinant
DNA
technology
in
a
Chinese
hamster
ovary
(CHO)
mammalian
cell
line.
After
reconstitution the vial contains 125 mg/ml of omalizumab (150 mg in
1.2 ml).
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.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION.
Powder: white to off-white lyophilizate in a glass vial.
Solvent: clear and colorless solution in a glass ampoule.
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Clear to slightly opalescent, colorless to pale brownish-yellow
solution in a pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALLERGIC ASTHMA
Xolair treatment should only be considered for patients with
convincing IgE mediated asthma (see
section 4.2).
ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND ABOVE)
Xolair is indicated as add-on therapy to improve asthma control in
adult and adolescent (12 years of age
and above) with severe persistent allergic asthma who have a positive
skin test or
_in vitro _
reactivity to a
Xolair Oct 2022.SIN Page 2 of 31
perennial aeroallergen and who