XOLAIR®
Omalizumab
For Subcutaneous Use
DESCRIPTION
Xolair (Omalizumab)
is a recombinant DNA-derived humanized IgG1
κ
monoclonal
antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a
molecular weight of approximately 149 kilodaltons. Xolair is produced by a Chinese
hamster ovary cell suspension culture in a nutrient medium containing the antibiotic
gentamicin. Gentamicin is not detectable in the final product.
Xolair
is a sterile, white, preservative-free, lyophilized powder contained in a single-use
vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and administered
as a subcutaneous (SC) injection. A Xolair vial contains 202.5 mg of Omalizumab,
145.5 mg sucrose, 2.8 mg L-histidine hydrochloride mono hydrate, 1.8 mg L-histidine and
0.5 mg polysorbate 20 and is designed to deliver 150 mg of Omalizumab, in 1.2 mL after
reconstitution with 1.4 mL SWFI, USP.
CLINICAL PHARMACOLOGY
Mechanism of Action
Xolair inhibits the binding of IgE to the high-affinity IgE receptor (Fc
ε
RI) on the surface
of mast cells and basophils. Reduction in surface bound IgE on Fc
ε
RI-bearing cells
limits the degree of release of mediators of the allergic response. Treatment with Xolair
also reduces the number of Fc
ε
RI receptors on basophils in atopic patients.
Pharmacokinetics
After SC administration, Omalizumab is absorbed with an average absolute
bioavailability of 62%. Following a single SC dose in adult and adolescent patients with
asthma, Omalizumab was absorbed slowly, reaching peak serum concentrations after an
average of 7-8 days. The pharmacokinetics of Omalizumab are linear at doses greater
than 0.5 mg/kg. Following multiple doses of Omalizumab, areas under the serum
concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those
after the first dose.
In vitro
, Omalizumab forms complexes of limited size with IgE. Precipitating complexes
and complexes larger than 1 million daltons in molecular weight are not observed
in vitro
or
in vivo
. Tissue distribution studies in cynomolgus monkeys showed no specific uptake
of
125
I-Omalizumab by any organ or tissue. The apparent volume of distribution in
patients following SC administration was 78
±
32 mL/kg.
Clearance of Omalizumab involves IgG clearance processes as well as clearance via
specific binding and complex formation with its target ligand, IgE. Liver elimination of
IgG includes degradation in the liver reticuloendothelial system (RES) and endothelial
cells. Intact IgG is also excreted in bile. In studies with mice and monkeys,
Omalizumab:IgE complexes were eliminated by interactions with Fc
γ
receptors within
the RES at rates that were generally faster than IgG clearance. In asthma patients
Omalizumab serum elimination half- life averaged 26 days, with apparent clearance
averaging 2.4
±
1.1 mL/kg/day. In addition, doubling body weight approximately
doubled apparent clearance.
Pharmacodynamics
In clinical studies, serum free IgE levels were reduced in a dose dependent manner within
1 hour following the first dose and maintained between doses. Mean serum free IgE
decrease was greater than 96% using recommended doses. Serum total IgE levels
(i.e., bound and unbound) increased after the first dose due to the formation of
Omalizumab:IgE complexe s which have a slower elimination rate compared with free
IgE. At 16 weeks after the first dose, average serum total IgE levels were five- fold
higher compared with pre-treatment when using standard assays. After discontinuation
of Xolair dosing, the Xolair induced increase in total IgE and decrease in free IgE were
reversible, with no observed rebound in IgE levels after drug washout. Total IgE levels
did not return to pre-treatment levels for up to one year after discontinuation of Xolair.
Special Populations
The population pharmacokinetics of Xolair were analyzed to evaluate the effects of
demographic characteristics. Analyses of these limited data suggest that no dose
adjustments are necessary for age (12-76 years), race, ethnicity or gender.
CLINICAL STUDIES
The safety and efficacy of Xolair were evaluated in three randomized, double-blind,
placebo controlled, multicenter trials.
The trials enrolled patients 12 to 76 years old, with moderate to severe persistent (NHLBI
criteria)
asthma for at least one year and a positive skin test reaction to a perennial
aeroallergen. At screening, patients in Studies 1 and 2 had a forced expiratory volume in
one second (FEV1) between 40% and 80% predicted, while in Study 3 there was no
restriction on screening FEV1. All patients had a FEV1 improvement of at least 12%
following beta-agonist administration. All patients were symptomatic and were being
treated with inhaled corticosteroids (ICS) and short acting beta-agonists. In Study 3,
long-acting beta-agonists were allowed. Study 3 patients were receiving at least 1000
µ
g/day fluticasone propionate and a subset was also receiving oral corticosteroids.
Patients receiving other concomitant controller medications were excluded, and initiation
of additional controller medications while on study was prohibited. Patients currently
smoking were excluded.
Each study was comprised of a run- in period to achieve a stable conversion to a common
ICS (beclomethasone dipropionate, for Studies 1 and 2; fluticasone propionate for Study
3), followed by randomization to Xolair or placebo. In Study 3, patients were stratified
by use of ICS-only or ICS with concomitant use of oral steroids. Patients received Xolair
for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation
necessitated an increase. Patients then entered an ICS reduction phase of 12 weeks
(Studies 1 and 2) or 16 weeks (Study 3) during which ICS (or oral steroid in Study 3
subset) dose reduction was attempted in a step-wise manner.
Xolair dosing was based on body weight and baseline serum total IgE concentration. All
patients were required to have a baseline IgE between 30 and 700 IU/mL and body
weight not more than 150 kg. Patients were treated according to a dosing table to
administer at least 0.016 mg/kg/IU [IgE/mL] of Xolair or a matching volume of placebo
over each 4 week period. The maximum Xolair dose per 4 weeks was 750 mg; patients
who had a weight-IgE combination that yielded a dose greater than 750 mg were
excluded from the studies. Patients who were to receive more than 300 mg within the 4
week period were administered half the total dose every 2 weeks.
The distribution of the number of asthma exacerbations per patient in each group during a
study was analyzed separately for the stable steroid and steroid-reduction periods. In all
three studies an exacerbation was defined as a worsening of asthma that required
treatment with systemic corticosteroids or a doubling of the baseline ICS dose.
In both Studies 1 and 2 the number of exacerbations per patient was reduced in patients
treated with Xolair compared with placebo (Table 1). In Study 3 the number of
exacerbations in patients treated with Xolair was similar to that in placebo-treated
patients (Table 2). The absence of an observed treatment effect in Study 3 may be related
to differences in the patient population compared with Studies 1 and 2, study sample size,
or other factors. In all three studies most exacerbations were managed in the out-patient
setting and the majority were treated with systemic steroids. Hospitalization rates were
not significantly different between Xolair and placebo-treated patients, however the
overall hospitalization rate was small. Among those patients who experienced an
exacerbation, the distribution of exacerbation severity was similar between treatment
groups.
Table 1
Frequency of Asthma Exacerbations per Patient by Phase in Studies 1 and 2
Stable Steroid Phase (16 wks)
Study 1
Study 2
Exacerbations per
patient
Xolair
N=268
(%)
Placebo
N=257
(%)
Xolair
N=274
(%)
Placebo
N=272
(%)
0
85.8
76.7
87.6
69.9
1
11.9
16.7
11.3
25.0
≥
2
2.2
6.6
1.1
5.1
P-value
0.005
< 0.001
Mean number
exacerbations/patient
0.2
0.3
0.1
0.4
Steroid Reduction Phase (12 wks)
Exacerbations per
patient
Xolair
N=268
(%)
Placebo
N=257
(%)
Xolair
N=274
(%)
Placebo
N=272
(%)
0
78.7
67.7
83.9
70.2
1
19.0
28.4
14.2
26.1
≥
2
2.2
3.9
1.8
3.7
P-value
0.004
< 0.001
Mean number
exacerbations/patient
0.2
0.4
0.2
0.3
Table 2
Percentage of Patients with Asthma Exacerbations by Subgroup and Phase in Study 3
Stable Steroid Phase (16 wks)
Inhaled Only
Oral+Inhaled
Xolair
N=126
Placebo
N=120
Xolair
N=50
Placebo
N=45
% Pts with
≥
1
exacerbations
15.9
15.0
32.0
22.2
Difference
(95% CI)
0.9
(-9.7, 13.7)
9.8
(-10.5, 31.4)
Steroid Reduction Phase (12 wks)
Xolair
N=126
Placebo
N=120
Xolair
N=50
Placebo
N=45
% Pts with
≥
1
exacerbations
22.2
26.7
42.0
42.2
Difference
(95% CI)
-4.4
(-17.6, 7.4)
-0.2
(-22.4, 20.1)
In all three of the studies, a reduction of asthma exacerbations was not observed in the
Xolair-treated patients who had FEV1 > 80% at the time of randomization. Reductions
in exacerbations were not seen in patients who required oral steroids as maintenance
therapy.
In Studies 1 and 2 measures of airflow (FEV1) and asthma symptoms were evaluated
(Table 3). The clinical relevance of the treatment-associated differences is unknown.
Table 3.
Asthma Symptoms and Pulmonary Function
During Stable Steroid Phase of Study 1
Xolair
N=268
1
Placebo
N=257
1
Endpoint
Mean
Baseline
Median
Change
(Baseline to
Wk 16)
Mean
Baseline
Median
Change
(Baseline to
Wk 16)
Total asthma symptom
score
4.3
-1.5*
4.2
-1.1*
Nocturnal asthma score
1.2
-0.4*
1.1
-0.2*
Daytime asthma score
2.3
-0.9*
2.3
-0.6*
FEV1 % predicted
68
3*
68
0*
Asthma symptom scale: total score from 0 (least) to 9 (most); nocturnal and daytime scores from 0 (least)
to 4 (most symptoms).
* Comparison of Xolair versus placebo (p < 0.05).
1
Number of patients available for analysis ranges 255-258 in the Xolair group and 238-239 in the
placebo group
Results from the stable steroid phase of Study 2 and the steroid reduction phases of both
Studies 1 and 2 were similar to those presented in Table 3.
INDICATIONS AND USAGE
Xolair is indicated for adults and adolescents (12 years of age and above) with moderate
to severe persistent asthma who have a positive skin test or
in vitro
reactivity to a
perennial aeroallergen and whose symptoms are inadequately controlled with inhaled
corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations
in these patients. Safety and efficacy have not been established in other allergic
conditions.
CONTRAINDICATIONS
Xolair should not be administered to patients who have experienced a severe
hypersensitivity reaction to Xolair (see WARNINGS: Anaphylaxis).
WARNINGS
Malignancy
Malignant neoplasms were observed in 20 of 4127 (0.5%) Xolair-treated patients
compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other
allergic disorders. The observed malignancies in Xolair-treated patients were a variety of
types, with breast, non- melanoma skin, prostate, melanoma, and parotid occurring more
than once, and five other types occurring once each. The majority of patients were
observed for less than 1 year. The impact of longer exposure to Xolair or use in patients
at higher risk for malignancy (e.g., elderly, current smokers) is not known (see
ADVERSE REACTIONS: Malignancy)
Anaphylaxis
Anaphylaxis has occurred within 2 hours of the first or subsequent administration of
Xolair in 3 (<0.1%) patients without other identifiable allergic triggers. These events
included urticaria and throat and/or tongue edema (See ADVERSE REACTIONS).
Patients should be observed after injection of Xolair, and medications for the treatment of
severe hypersensitivity reactions including anaphylaxis should be available. If a severe
hypersensitivity reaction to Xolair occurs, therapy should be discontinued (see
CONTRAINDICATIONS).
PRECAUTIONS
General
Xolair has not been shown to alleviate asthma exacerbations acutely and should not be
used for the treatment of acute bronchospasm or status asthmaticus.
Corticosteroid Reduction
Systemic or inhaled corticosteroids should not be abruptly discontinued upon initiation of
Xolair therapy. Decreases in corticosteroids should be performed under the direct
supervision of a physician and may need to be performed gradually.
Information for Patients
Patients receiving Xolair should be told not to decrease the dose of, or stop taking any
other asthma medications unless otherwise instructed by their physician. Patients should
be told that they may not see immediate improvement in their asthma after beginning
Xolair therapy.
Laboratory Tests
Serum total IgE leve ls increase following administration of Xolair due to formation of
Xolair:IgE complexes (See CLINICAL PHARMACOLOGY, DOSAGE AND
ADMINISTRATION). Elevated serum total IgE levels may persist for up to 1 year
following discontinuation of Xolair. Serum total IgE levels obtained less than 1 year
following discontinuation may not reflect steady state free IgE levels and should not be
used to reassess the dosing regimen.
Drug Interactions
No formal drug interaction studies have been performed with Xolair. The concomitant
use of Xolair and allergen immunotherapy has not been evaluated
.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies have been performed in animals to evaluate the carcinogenic
potential of Xolair.
No evidence of mutagenic activity was observed in Ames tests using six different strains
of bacteria with and without metabolic activation at Omalizumab concentrations up to
5000
µ
g/mL.
The effects of Omalizumab on male and female fertility have been assessed in
cynomolgus monkey studies. Administration of Omalizumab at doses up to and
including 75 mg/kg/week did not elicit reproductive toxicity in male cynomolgus
monkeys and did not inhibit reproductive capability, including implantation, in female
cynomolgus monkeys. These doses provide a 2- to 16-fold safety factor based on total
dose and 2- to 5- fold safety factor based on AUC over the range of adult clinical doses.
Pregnancy (Category B)
Reproduction studies in cynomolgus monkeys have been conducted with Omalizumab.
Subcutaneous doses up to 75 mg/kg (12- fold the maximum clinical dose) of Omalizumab
did not elicit maternal toxicity, embryotoxicity, or teratogenicity when administered
throughout organogenesis and did not elicit adverse effects on fetal or neonatal growth
whe n administered throughout late gestation, delivery, and nursing.
IgG molecules are known to cross the placental barrier. There are no adequate and well-
controlled studies of Xolair in pregnant women. Because animal reproduction studies are
not always predictive of human response, Xolair should be used during pregnancy only if
clearly needed.
Nursing Mothers
The excretion of Omalizumab in milk was evaluated in female cynomolgus monkeys
receiving SC doses of 75 mg/kg/week. Neonatal plasma levels of Omalizumab after
in
utero
exposure and 28 days of nursing were between 11% and 94% of the maternal
plasma level. Milk levels of Omalizumab were 1.5% of maternal blood concentration.
While Xolair presence in human milk has not been studied, IgG is excreted in human
milk and therefore it is expected that Xolair will be present in human milk. The potential
for Xolair absorption or harm to the infant are unknown; caution should be exercised
when administering Xolair to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been
established.
Geriatric Use
In clinical trials 134 patients 65 years of age or older were treated with Xolair. Although
there were no apparent age-related differences observed in these studies, the number of
patients aged 65 and over is not sufficient to determine whether they respond differently
from younger patients.
ADVERSE REACTIONS
The most serious adverse reactions occurring in clinical studies with Xolair are
malignancies and anaphylaxis (see WARNINGS). The observed incidence of
malignancy among Xolair-treated patients (0.5%) was numerically higher than among
patients in control groups (0.2%). Anaphylactic reactions were rare but temporally
associated with Xolair administration.
The adverse reactions most commonly observed among patients treated with Xolair
included injection site reaction (45%), viral infections (23%), upper respiratory tract
infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events
were observed at similar rates in Xolair-treated patients and control patients. These were
also the most frequently reported adverse reactions resulting in clinical intervention (e.g.,
discontinuation of Xolair, or the need for concomitant medication to treat an adverse
reaction).
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of one drug cannot be directly compared with rates in
the clinical trials of another drug and may not reflect the rates observed in medical
practice.
The data described above reflect Xolair exposure for 2076 adult and adolescent patients
ages 12 and older, including 1687 patients exposed for six months and 555 exposed for
one year or more, in either placebo-controlled or other controlled asthma studies. The
mean age of patients receiving Xolair was 42 years, with 134 patients 65 years of age or
older; 60% were women, and 85% Caucasian. Patients received Xolair 150 to 375 mg
every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or
without a placebo.
Table 4 shows adverse events that occurred
≥
1% more frequently in patients receiving
Xolair than in those receiving placebo in the placebo controlled asthma studies. Adverse
events were classified using preferred terms from the International Medical
Nomenclature (IMN) dictionary. Injection site reactions were recorded separately from
the reporting of other adverse events and are described following Table 4.
Table 4
Adverse Events
≥
1% More Frequent in
Xolair-Treated Patients
Adverse event
Xolair
n = 738
(%)
Placebo
n = 717
(%)
Body as a whole
Pain
7
5
Fatigue
3
2
Musculoskeletal system
Arthralgia
8
6
Fracture
2
1
Leg pain
4
2
Arm pain
2
1
Nervous system
Dizziness
3
2
Skin and appendages
Pruritus
2
1
Dermatitis
2
1
Special senses
Ear ache
2
1
Age (among patients under age 65), race, and gender did not appear to affect the between
group differences in the rates of adverse events.
Injection Site Reactions
Injection site reactions of any severity occurred at a rate of 45% in Xolair-treated patients
compared with 43% in placebo-treated patients. The types of injection site reactions
included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain,
indurations, mass, and inflammation.
Severe injection-site reactions occurred more frequently in Xolair-treated patients
compared with patients in the placebo group (12% versus 9%).
The majority of injection site reactions occurred within 1 hour-post injection, lasted less
than 8 days, and generally decreased in frequency at subsequent dosing visits.
Immunogenicity
Low titers of antibodies to Xolair were detected in approximately 1 /1723 (<0.1%) of
patients treated with Xo lair. The data reflect the percentage of patients whose test results
were considered positive for antibodies to Xolair in an ELISA assay and are highly
dependent on the sensitivity and specificity of the assay. Additionally, the observed
incidence of ant ibody positivity in the assay may be influenced by several factors
including sample handling, timing of sample collection, concomitant medications, and
underlying disease. Therefore, comparison of the incidence of antibodies to Xolair with
the incidence of antibodies to other products may be misleading.
Allergic symptoms, including urticaria,
dermatitis and pruritus
were observed in patients
treated with Xolair. There were also 3 cases of anaphylaxis observed within 2 hours of
Xolair administration in which there were no other identifiable allergic triggers (see
WARNINGS: Anaphylaxis).
OVERDOSAGE
The maximum tolerated dose of Xolair has not been determined. Single intravenous
doses of
up to 4000 mg have been administered to patients without evidence of
dose-limiting toxicities. The highest cumulative dose administered to patients was
44,000 mg over a 20-week period, which was not associated with toxicities.
DOSAGE AND ADMINISTRATION
Xolair 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is
slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and
dosing frequency are determined by serum total IgE level (IU/mL), measured before the
start of treatment, and body weight (kg). See the dose determination charts below
(Table 5 and Table 6) for appropriate dose assignment. Doses of more than 150 mg are
divided among more than one injection site to limit injections to not more than 150 mg
per site.
Table 5
ADMINISTRATION EVERY 4 WEEKS
Xolair Doses (milligrams) Administered by Subcutaneous
Injection Every 4 Weeks for Adults and Adolescents (12 Years of
Age and Older) with Asthma
Body Weight (kg)
Pre-
treatment
Serum IgE
(IU/mL)
30-60
> 60-70
> 70-90
> 90-150
≥
30-100
150
150
150
300
> 100-200
300
300
300
> 200-300
300
> 300-400
> 400-500
> 500-600
Table 6
ADMINISTRATION EVERY 2 WEEKS
Xolair Doses (milligrams) Administered by Subcutaneous
Injection Every 2 Weeks for Adults and Adolescents (12
Years of Age and Older) with Asthma
Body Weight (kg)
Pre-
treatment
Serum IgE
(IU/mL)
30-60
> 60-70
> 70-90
> 90-150
≥
30-100
> 100-200
225
> 200-300
225
225
300
> 300-400
225
225
300
> 400-500
300
300
375
> 500-600
300
375
> 600-700
375
SEE TABLE 6
DO NOT DOSE
SEE TABLE 5
Dosing Adjustments
Total IgE levels are elevated during treatment and remain elevated for up to one year
after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair
treatment cannot be used as a guide for dose determination. Dose determination after
treatment interruptions lasting less than 1 year should be based on serum IgE levels
obtained at the initial dose determination. Total serum IgE levels may be re-tested for
dose determination if treatment with Xolair has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight. (See Table
5
and
Table
6
).
Preparation for Administration
Xolair for SC administration should be prepared using SWFI, USP ONLY.
Xolair is for single use only and contains no preservatives. The solution should be used
for SC administration within 8 hours following reconstitution when stored in the vial at
2
−
8
°
C (36-46
°
F), or within 4 hours of reconstitution when stored at room temperature.
The lyophilized product takes 15-20 minutes to dissolve. The fully reconstituted product
will appear clear or slightly opalescent and may have a few small bubbles or foam around
the edge of the vial. The reconstituted product is somewhat viscous; in order to obtain
the full 1.2 mL dose ALL OF THE PRODUCT MUST BE WITHDRAWN from the vial
before expelling any air or excess solution from the syringe.
STEP 1:
Draw 1.4 mL of SWFI, USP
into a 3-cc syringe equipped with a 1- inch,
18-gauge needle.
STEP 2:
Place the vial upright on a flat surface and using standard aseptic technique,
insert the needle and inject the SWFI, USP directly onto the product.
STEP 3:
Keeping the vial upright, gently swirl the upright vial for approximately
1 minute to evenly wet the powder. Do not shake.
STEP 4:
After completing STEP 3, gently swirl the vial for 5-10 seconds approximately
every 5 minutes in order to dissolve any remaining solids. There should be no visible
gel- like particles in the solution. Do not use if foreign particles are present.
Note: Some vials may take longer than 20 minutes to dissolve completely. If this is
the case, repeat STEP 4 until there are no visible gel- like particles in the solution. It
is acceptable to have small bubbles or foam around the edge of the vial. Do not use
if the contents of the vial do not dissolve completely by 40 minutes.
STEP 5:
Invert the vial for 15 seconds in order to allow the solution to drain toward the
stopper. Using a new 3-cc syringe equipped with a 1- inch, 18-gauge needle, insert the
needle into the inverted vial. Position the needle tip at the very bottom of the solution in
the vial stopper when drawing the solution into the syringe. Before removing the needle
from the vial, pull the plunger all the way back to the end of the syringe barrel in order to
remove all of the solution from the inverted vial.
STEP 6:
Replace the 18- gauge needle with a 25- gauge needle for subcutaneous
injection.
STEP 7:
Expel air, large bubbles, and any excess solution in order to obtain the required
1.2 mL dose. A thin layer of small bubbles may remain at the top of the solution in the
syringe. Because the solution is slightly viscous, the injection may take 5-10 seconds to
administer.
A vial delivers 1.2 mL (150 mg) of Xolair. For a 75 mg dose, draw up 0.6 mL into the
syringe and discard the remaining product (see Table 7).
Table 7
Number of Injections and Total Injection Volumes
for Allergic Asthma
Dose (mg)
Number of Injections
Total Volume Injected
(mL)
a
150
1
1.2
225
2
1.8
300
2
2.4
375
3
3.0
a
1.2 mL maximum delivered volume per vial.
Stability and Storage
Xolair
should be shipped at controlled ambient temperature (
≤
30
°
C [
≤
86
°
F]). Xolair
should be stored under refrigerated conditions 2-8
°
C (36-46
°
F). Do not use beyond the
expiration date stamped on carton.
Xolair is for single- use only and contains no preservatives. The solution may be used for
SC administration within 8 hours following reconstitution when stored in the vial at
2
−
8
°
C (36-46
°
F), or within 4 hours of reconstitution when stored at room temperature.
Reconstituted Xolair vials should be protected from direct sunlight.
HOW SUPPLIED
Xolair
is supplied as a lyophilized, sterile powder in a single- use, 5-cc vial that is
designed to deliver 150 mg of Xolair upon reconstitution with 1.4 mL SWFI, USP.
Each carton contains one single-use vial of Xolair
®
(Omalizumab) NDC 50242-040-62.
XOLAIR®
Omalizumab
For
Subcutaneous Use
Manufactured by:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
Jointly marketed by:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
4821000
Issued: Date
?
2003 Genentech, Inc.