XOLAIR® (omalizumab) for subcutaneous use 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.
Important Limitations of Use
- XOLAIR is not indicated for treatment of other allergic conditions
- XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
- XOLAIR is not indicated for use in pediatric patients less than 12 years of age
Important Safety Information for XOLAIR
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, observe patients closely for an appropriate period of time after XOLAIR administration. Healthcare providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and Precautions: Anaphylaxis).
XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions).
WARNINGS AND PRECAUTIONS
Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be 0.1%. 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.
Administer XOLAIR only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that 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.
Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction (see Contraindications).
Anaphylaxis in postmarketing spontaneous reports:
anaphylaxis by dose
|Occurrence after 1st dose||39% (48/124)|
|Occurrence after 2nd dose||19% (23/124)|
|Occurrence after 3rd dose||10% (12/124)|
|Occurrence after subsequent doses*||33% (41/124)|
Anaphylaxis in postmarketing spontaneous reports:
time to onset of anaphylaxis
|≤30 minutes||35% (43/124)|
|>30 minutes to ≤60 minutes||16% (20/124)|
|>60 minutes to ≤90 minutes||2% (3/124)|
|>90 minutes to ≤120 minutes||6% (8/124)|
|>2 hours to ≤6 hours||5% (6/124)|
|>6 hours to ≤12 hours||14% (17/124)|
|>12 hours to ≤24 hours||8% (10/124)|
|>24 hours to ≤4 days||5% (6/124)|
|Time to onset unknown||9% (11/124)|
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 5 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 (eg, elderly, current smokers) is not known (see Adverse Reactions).
Acute Asthma Symptoms
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
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.
Fever, Arthralgia, and Rash
A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. These signs and symptoms have begun one to five days after the first or subsequent injections of XOLAIR. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Adverse reactions ≥1% more frequent in XOLAIR-treated adult or adolescent patients ≥12 years†
|Body as a whole
|Skin and appendages
Adverse events most frequently resulting in clinical intervention (eg, discontinuation of XOLAIR,
or the need for concomitant
medication to treat an adverse event)‡
||Resulted in clinical intervention (%)
|Injection site reactions
|Upper respiratory tract infection
In an additional study of patients taking high-dose ICS + LABA +/- additional controller medications, the incidence of adverse events was similar in the XOLAIR and placebo groups. The most commonly affected organ class for both treatment groups was infections and infestations, followed by respiratory, gastrointestinal, musculoskeletal and connective tissue, and nervous system. Only events in the categories infections and infestations, and respiratory, occurred at an incidence of >20% among subjects in both treatment groups.
USE IN SPECIFIC POPULATIONS
Pregnancy (Category B)
There are no adequate and well-controlled studies of XOLAIR in pregnant women. XOLAIR should be used during pregnancy only if clearly needed.
Pregnancy Exposure Registry
To monitor outcomes of pregnant women exposed to XOLAIR, including women who are exposed to at least 1 dose of XOLAIR
within 8 weeks prior to conception or any time during pregnancy, a pregnancy exposure registry has been established.
Encourage patients to call 1-866-4XOLAIR (1-866-496-5247) to enroll in the XOLAIR Pregnancy Exposure Registry.
Healthcare providers can call this number to obtain further information about this registry.
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.
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.
Please see accompanying full
Prescribing Information, including
Boxed WARNING and
for additional important safety information.
†From 4 placebo-controlled asthma studies.
‡Data reflecting XOLAIR exposure for 2076 adult and adolescent patients aged ≥12 years in either placebo-controlled or other controlled asthma studies. These events were observed at similar rates in XOLAIR-treated patients and control patients.