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CSU=chronic spontaneous urticaria

 

INDICATION  
XOLAIR^®(omalizumab) is indicated for the treatment of 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.

 

IMPORTANT SAFETY INFORMATION

 

CONTRAINDICATION 
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 for a different indication, 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 in asthma patients 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 lifethreatening.

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 or 
autoinjector 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 or autoinjector 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) for a different indication 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 for a different indication 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.

Corticosteroid Reduction: 
In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

 

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.

 

Potential Medication Error Related to Emergency Treatment of Anaphylaxis 
XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis. In studies to simulate use, some patients and caregivers did not understand that XOLAIR is not intended for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of XOLAIR for emergency treatment of allergic reactions, including anaphylaxis, have not been established. Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

 

ADVERSE REACTIONS

Chronic Spontaneous Urticaria: 
The most common adverse reactions (≥2% incidence in 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: 
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.

 

Injection Site Reactions in Healthy Adults: 
In an open label trial in healthy adults, in which the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe, injection site reactions (e.g., induration, pain, erythema, hemorrhage, swelling, discomfort, bruising, hypoesthesia, edema, pruritus) were observed in 24% (16/66) of subjects treated with the autoinjector compared with 14% (9/64) of subjects treated with the prefilled syringe.

 

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients for a Different 
Indication: 
A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non- 
XOLAIR-treated patients ≥12 years of age for a different indication to evaluate the long term safety 
of XOLAIR, including the risk of malignancy. 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.