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Xolair (Omalizumab) - Warnings and Precautions

 
 



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 levels 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 µg/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 when 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.

Page last updated: 2006-09-01

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