A recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Xolair is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin.

Xolair - Pharmacology:

Xolair binds to IgE (a class of antibodies normally secreted in allergic responses), which prevents their binding to mast cells and basophils.

Xolair mini report

Xolair BLA
BLA - A product marketed under an approved Biologic License Application
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not occurred

Xolair 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 Xolair concentrations up to 5000 m g/mL.

The effects of Xolair on male and female fertility have been assessed in cynomolgus monkey studies. Administration of Xolair 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 Xolair. Subcutaneous doses up to 75 mg/kg (12-fold the maximum clinical dose) of Xolair 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 Xolair in milk was evaluated in female cynomolgus monkeys receiving SC doses of 75 mg/kg/week. Neonatal plasma levels of Xolair after in utero exposure and 28 days of nursing were between 11% and 94% of the maternal plasma level. Milk levels of Xolair 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.

Xolair Contraindications

Xolair should not be administered to patients who have experienced a severe hypersensitivity reaction to Xolair.

Generic name, Overdose, Half Life Xolair, Food Interactions, Chemical, etc..

Xolair see also