XOLAIR 150 MG AMP
ACTIVE-INGREDIENT OF XOLAIR 150 MG 2 ML 1 AMP
INDICATION OF XOLAIR 150 MG 2 ML 1 AMP
With a consistent focus on quality, our company is engaged in offering a vast range of Injection XOLAIR 150 MG 2 ML 1 AMP Omalizumab to our clients. This product is appreciated for its premium quality, accurate composition and long shelf life. Moreover, the offered product can be obtained in varied packaging options to choose from. In addition to this, used for Respiratory disorders, this medicine is used to treat moderate or severe asthma in adults and children over 12 Yrs of age.
fertility, pregnancy, and lactation FOR XOLAIR 150 MG 2 ML 1 AMP
- XOLAIR 150 MG 2 ML 1 AMP A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity. A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to Xolair showed the prevalence of major congenital anomalies was similar (8.1% vs. 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
- Omalizumab crosses the placental barrier. However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
- Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
- If clinically needed, the use of Xolair may be considered during pregnancy.
- XOLAIR 150 MG 2 ML 1 AMP Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk. Available data in non-human primates have shown excretion of omalizumab into milk (see section 5.3).
- The EXPECT study, with 154 infants who had been exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects on the breast-fed infant. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
- Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breast-fed newborns/infants are anticipated. Consequently, if clinically needed, the use of Xolair may be considered during breast-feeding.
There are no human fertility data for omalizumab. In specifically-designed non-clinical fertility studies, in non-human primates including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg. Furthermore, no genotoxic effects were observed in a separate non-clinical genotoxicity study.