Xolair (Genentech Inc)
Xolair (Genentech Inc) - General Information
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.
Pharmacology of Xolair (Genentech Inc)
Xolair inhibits the binding of IgE to the high-affinity IgE receptor (FceRI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on FceRI-bearing cells limits the degree of release of mediators of the allergic response. Xolair is used to treat severe, persisten asthma.
Xolair (Genentech Inc) for patients
Xolair (Genentech Inc) 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 m g/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.
Xolair (Genentech Inc) Contraindications
Xolair should not be administered to patients who have experienced a severe hypersensitivity reaction to Xolair.
Additional information about Xolair (Genentech Inc)
Xolair (Genentech Inc) Indication: For treatment of asthma caused by allergies
Mechanism Of Action: Xolair binds to IgE (a class of antibodies normally secreted in allergic responses), which prevents their binding to mast cells and basophils.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Omalizumab
Synonyms: Ig gamma-1 chain C region
Drug Category: Anti-Asthmatic Agents; Immunomodulatory Agents
Drug Type: Biotech; Approved; Investigational
Other Brand Names containing Omalizumab: Xolair (Genentech Inc);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Most likely removed by opsonization via the reticuloendothelial system.
Half Life: 26 days
Dosage Forms of Xolair (Genentech Inc): Powder, for solution Subcutaneous
Chemical IUPAC Name: Humanized anti-IgE antibody
Chemical Formula: C6450H9916N1714O2023S38
Omalizumab on Wikipedia: https://en.wikipedia.org/wiki/Omalizumab
Organisms Affected: Humans and other mammals