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Prescribing Information

For Patients and Caregivers

Contact a Rep Contact a Rep INSTRUCTIONS FOR USE Instructions for Use
Prescribing Information Prescribing Information Safety Safety

MENU

   
 * Allergic Asthma
    * When to Consider XOLAIR
    * Efficacy & Safety for XOLAIR
    * Pregnancy Registry Data

 * Chronic Spontaneous Urticaria
    * When to Consider XOLAIR
    * Efficacy & Safety for XOLAIR

 * Nasal Polyps
 * Dosing and Administration
    * Dosing
    * Preparation & Administration

 * Access and Resources
    * Patient Support & Resources
    * Financial Assistance

   

CONTACT A REP Instructions for Use Safety
For Patients and Caregivers


XOLAIR FINANCIAL ASSISTANCE & OFFICE SUPPORT

Get support for your practice and patients. Genentech offers help with access,
billing, distribution, and patient education after XOLAIR is prescribed.


XOLAIR ACCESS SOLUTIONS FOR YOUR PRACTICE

XOLAIR Access Solutions focuses on access, so you can focus on health. XOLAIR
Access Solutions is your resource for effective access and reimbursement
services.

The first step is to have patients complete and submit the Respiratory Patient
Consent Form. Your office must also complete a Prescriber Service Form. Once we
have both forms, XOLAIR Access Solutions can begin working with you. Learn more
about how XOLAIR Access Solutions can help you and your patients.


PATIENT SUPPORT MATERIALS

Get support for your practice with tools, resources, and educational materials
to help patients access and understand their XOLAIR treatment.

Additionally, provide support for your patients with a variety of downloadable
resources, along with the programs below.


THE SUPPORT FOR YOU PROGRAM

When patients sign up for the Support For You Program, they will get tools and
resources to support their treatment journey such as:

 1. Information about XOLAIR and their disease state
    
 2. Positive support and motivation to stay on their treatment plan

Learn more about the Support For You Program for Allergic Asthma
Patients and Support For You Program for CSU Patients. 


VOICES OF INSPIRATION

Voices of Inspiration is a volunteer patient network where patients and
caregivers can share their personal experiences with XOLAIR. Their stories can
help other patients avoid feeling isolated, understand next steps for treatment,
and provide encouragement.


Some examples of real patients' stories that have come from Voices of
Inspiration are below.
Allergic Asthma Patient Stories 
CSU Patient Stories

IMPORTANT SAFETY INFORMATION

Back to Top

INDICATIONS
XOLAIR® (OMALIZUMAB) IS INDICATED FOR:



 * Adults and pediatric patients 6 years of age and older 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.
   
   Limitations of Use: XOLAIR is not indicated for the relief of acute
   bronchospasm, status asthmaticus, or for treatment of other allergic
   conditions.
   
   
 * Add-on maintenance treatment of nasal polyps in adult patients 18 years of
   age and older with inadequate response to nasal corticosteroids.
   
   
 * Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age
   and older who remain symptomatic despite H1 antihistamine treatment.
   
   Limitations of Use: XOLAIR is not indicated for treatment of other forms of
   urticaria.

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or
angioedema of the throat or tongue, has been reported to occur after
administration of XOLAIR. Anaphylaxis has occurred as early as after the first
dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly
administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR
therapy in a healthcare setting and closely observe patients for an appropriate
period of time after XOLAIR administration. Health care providers administering
XOLAIR should be prepared to manage anaphylaxis which can be life-threatening.
Inform patients of the signs and symptoms of anaphylaxis and instruct them to
seek immediate medical care should symptoms occur. Selection of patients for
self-administration of XOLAIR should be based on criteria to mitigate risk from
anaphylaxis.

CONTRAINDICATIONS

XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to
XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis
Anaphylaxis has been reported to occur after administration of XOLAIR in
premarketing clinical trials and in postmarketing spontaneous reports. In
premarketing clinical trials in patients with asthma, anaphylaxis was reported
in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR
in two patients and with the fourth dose in one patient. The time to onset of
anaphylaxis was 90 minutes after administration in two patients and 2 hours
after administration in one patient.

A case-control study showed that, among XOLAIR users, patients with a history of
anaphylaxis to foods, medications, or other causes were at increased risk of
anaphylaxis associated with XOLAIR, compared to those with no prior history of
anaphylaxis.

In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to
XOLAIR use was estimated to be at least 0.2% of patients based on an estimated
exposure of about 57,300 patients from June 2003 through December 2006.
Approximately 60% to 70% of anaphylaxis cases have been reported to occur within
the first three doses of XOLAIR, with additional cases occurring sporadically
beyond the third dose.

Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis
which can be life-threatening. Observe patients closely for an appropriate
period of time after administration of XOLAIR, taking into account the time to
onset of anaphylaxis seen in premarketing clinical trials and postmarketing
spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis,
and instruct them to seek immediate medical care should signs or symptoms occur.

Once XOLAIR therapy has been established, administration of XOLAIR Prefilled
Syringe outside of a healthcare setting by a patient or a caregiver may be
appropriate for selected patients. Patient selection, determined by the
healthcare provider in consultation with the patient, should take into account
the pattern of anaphylaxis events seen in premarketing clinical trials and
postmarketing spontaneous reports, as well as individual patient risk factors
(e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of
anaphylaxis, and ability to perform subcutaneous injections with XOLAIR
Prefilled Syringe with proper technique according to the prescribed dosing
regimen and Instructions for Use.

Discontinue XOLAIR in patients who experience a severe hypersensitivity
reaction.

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 adults
and adolescents (≥12 years of age) with 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.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829
non-XOLAIR-treated adolescent and adult patients with moderate to severe
persistent asthma and a positive skin test reaction or in vitro reactivity to a
perennial aeroallergen found that the incidence rates of primary malignancies
(per 1000 patient years) were similar in both groups (12.3 vs 13.0,
respectively). Study limitations which include the observational study design,
the bias introduced by allowing enrollment of patients previously exposed to
XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a
premalignant condition were study exclusion criteria, and the high study
discontinuation rate (44%) preclude definitively ruling out a malignancy risk
with XOLAIR.

Acute Asthma Symptoms and Deteriorating Disease
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use
XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek
medical advice if their asthma remains uncontrolled or worsens after initiation
of treatment with XOLAIR.

Corticosteroid Reduction
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation
of XOLAIR therapy for asthma or nasal polyps. Decrease corticosteroids gradually
under the direct supervision of a physician. In CSU patients, the use of XOLAIR
in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions
In rare cases, patients with asthma on therapy with XOLAIR may present with
serious systemic eosinophilia, sometimes presenting with clinical features of
vasculitis consistent with Churg-Strauss syndrome. These events usually, but not
always, have been associated with the reduction of oral corticosteroid therapy.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary
symptoms, cardiac complications, and/or neuropathy presenting in their patients.
A causal association between XOLAIR and these underlying conditions has not been
established.

Fever, Arthralgia, and Rash
In post-approval use, some patients have experienced a constellation of signs
and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy
with an onset 1 to 5 days after the first or subsequent injections of XOLAIR.
These signs and symptoms have recurred after additional doses in some patients.
Physicians should stop XOLAIR if a patient develops this constellation of signs
and symptoms.

Parasitic (Helminth) Infection
Monitor patients at high risk of geohelminth infection while on XOLAIR therapy.
Insufficient data are available to determine the length of monitoring required
for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests
Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase
following administration of XOLAIR and may remain elevated for up to 1 year
following discontinuation of XOLAIR. Do not use serum total IgE levels obtained
less than 1 year following discontinuation to reassess the dosing regimen for
asthma or nasal polyps patients, because these levels may not reflect steady
state free IgE levels.

ADVERSE REACTIONS

Asthma
In patients ≥12 years of age, the most common adverse reactions (≥1% more
frequent in XOLAIR-treated patients) were: arthralgia (8%), pain (general) (7%),
leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%),
pruritus (2%), dermatitis (2%), and earache (2%). In pediatric patients 6 to <12
years of age, the most commonly observed adverse reactions (≥3% more frequent in
XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia,
upper abdominal pain, pharyngitis streptococcal, otitis media, viral
gastroenteritis, arthropod bite, and epistaxis.

Nasal Polyps
The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and
more frequent than placebo) included: headache (8.1%), injection site reaction
(5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

Chronic Spontaneous Urticaria
The most common adverse reactions (≥2% XOLAIR-treated patients and more frequent
than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache
(12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper
respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper
respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Asthma
In adults and adolescents with asthma, injection site reactions of any severity
occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in
placebo-treated patients. Severe injection site reactions occurred more
frequently in XOLAIR‑treated patients compared with patients in the placebo
group (12% vs 9%, respectively). The types of injection site reactions in asthma
studies included: bruising, redness, warmth, burning, stinging, itching, hive
formation, pain, indurations, mass, and inflammation.

Nasal Polyps
Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients
compared with 1.5% in placebo-treated patients. Injection site reactions were
mild to moderate severity and none resulted in study discontinuation.

Chronic Spontaneous Urticaria
Injection site reactions of any severity occurred in more XOLAIR-treated
patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared
with 2 placebo-treated patients (0.8%). The types of injection site reactions
included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria.
None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with
Asthma
A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829
non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent
asthma and a positive skin test reaction to a perennial aeroallergen to evaluate
the long term safety of XOLAIR, including the risk of malignancy. Similar
percentages of patients in both cohorts were current (5%) or former smokers
(29%). Patients had a mean age of 45 years and were followed for a mean of 3.7
years. More XOLAIR-treated patients were diagnosed with severe asthma (50%)
compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per
1000 patient-years) of overall cardiovascular and cerebrovascular serious
adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to
non-XOLAIR-treated patients (8.1). Increases in rates were observed for
transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8),
pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs
1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic
stroke and cardiovascular death were similar among both study cohorts. The
results suggest a potential increased risk of serious cardiovascular and
cerebrovascular events in patients treated with XOLAIR, however the
observational study design, the inclusion of patients previously exposed to
XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk
factors between the treatment groups, an inability to adjust for unmeasured risk
factors, and the high study discontinuation rate (44%) limit the ability to
quantify the magnitude of the risk.

Pregnancy
Data with XOLAIR use in pregnant women are insufficient to inform on drug
associated risk.

You may report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to Genentech at (888)
835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Boxed WARNING and Medication
Guide, for additional Important Safety Information.





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