XOLAIR Indications and Important Safety Information
XOLAIR® (omalizumab) 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.
- With chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.
Important Limitations of Use
- XOLAIR is not indicated for treatment of other allergic conditions or other forms of urticaria.
- 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
The use of XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.
WARNINGS AND PRECAUTIONS
Anaphylaxis has been reported to occur after administration of XOLAIR in allergic asthma premarketing clinical trials and in postmarketing spontaneous reports. The frequency of anaphylaxis attributed to XOLAIR use was estimated to be 0.1% and at least 0.2% (based on an estimated exposure of about 57,300 patients from June 2003 through December 2006), respectively. 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. Anaphylaxis occurred with the first dose of XOLAIR in 2 patients and with the fourth dose in 1 patient; the time to onset of anaphylaxis was 90 minutes after administration in 2 patients and 2 hours after administration in 1 patient.
Malignant neoplasms were observed in 0.5% XOLAIR-treated patients compared with 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. 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.
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 for allergic asthma. 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. 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 postapproval 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.
Indication-Specific Adverse Reactions
In patients ≥12 years of age, the most commonly observed adverse reactions (≥1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies 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%).
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% vs 9%, respectively).
Chronic Idiopathic Urticaria:
In patients ≥12 years of age, the most commonly observed adverse events: (≥2% XOLAIR-treated patients and more frequent than in placebo) from 3 placebo-controlled CIU studies (Day 1 to Week 12) for XOLAIR 150 mg and 300 mg, respectively, were: 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%).
Additional events reported during the 24-week treatment period in Studies 1 and 3 (≥2% of patients receiving XOLAIR [150 or 300 mg] and more frequently than those receiving placebo) included: toothache, fungal infection, urinary tract infection, myalgia, pain in extremity, musculoskeletal pain, peripheral edema, pyrexia, migraine, sinus headache, anxiety, oropharyngeal pain, asthma, urticaria, and alopecia.
Injection Site Reactions
Injection site reactions of any severity occurred during the trials 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.
USE IN SPECIFIC POPULATIONS
Pregnancy (Category B)
Adequate and well controlled studies with XOLAIR have not been conducted in pregnant women. XOLAIR should be used during pregnancy only if clearly needed.
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.