tezepelumab - search results

tezspire

astrazeneca (israel) ltd - tezepelumab - solution for injection - tezepelumab 110 mg/ml - tezepelumab - tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

United States - English - NLM (National Library of Medicine)

tezspire- tezepelumab-ekko injection, solution

amgen, inc - tezepelumab (unii: rj1iw3b4qx) (tezepelumab - unii:rj1iw3b4qx) - tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. limitations of use: tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus. tezspire is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients [see warnings and precautions (5.1)] . risk summary there are no available data on tezspire use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. in an enhanced pre- and post-natal development (eppnd) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (mrhd) of 210 mg administered subcutaneously (see data) . the estimated background risk of major birth defects and miscarriages for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: in women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. the level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. data animal data in the eppnd study, pregnant cynomolgus monkeys received tezepelumab-ekko from gd20 to gd22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at doses that produced exposures up to 168 times that achieved with the mrhd (on an auc basis with maternal intravenous doses up to 300 mg/kg/week). there were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6.5 months of age. tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals. risk summary there is no information regarding the presence of tezepelumab-ekko in human milk, its effects on the breastfed infant, or its effects on milk production. however, tezepelumab-ekko is a human monoclonal antibody immunoglobulin g2λ (igg2λ), and immunoglobulin g (igg) is present in human milk in small amounts. tezepelumab‑ekko was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tezspire and any potential adverse effects on the breastfed infant from tezspire or from the underlying maternal condition. data animal data in a prenatal and postnatal development study in cynomolgus monkeys, tezepelumab-ekko concentrations in milk were up to 0.5% of the maternal serum concentrations after intravenous administration of tezepelumab-ekko up to 300 mg/kg/week (168 times the exposures based on auc achieved at mrhd). the concentration of tezepelumab-ekko in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of tezspire for the add-on maintenance treatment of severe asthma have been established in pediatric patients aged 12 years and older [see adverse reactions (6.1) and clinical studies (14)] . use of tezspire for this indication is supported by evidence from a total of 82 pediatric patients aged 12 to 17 years enrolled in navigator and received treatment with tezspire 210 mg subcutaneously every 4 weeks (n=41) or placebo (n=41). compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% ci 0.34, 1.46) and fev1 (ls mean change versus placebo 0.17 l; 95% ci -0.01, 0.35) were observed in pediatric patients treated with tezspire. the safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population. the safety and effectiveness in patients younger than 12 years of age have not been established. of the 665 patients with asthma treated with tezspire in clinical trials (pathway and navigator) for severe asthma, 119 patients (18%) were 65 years or older. no overall differences in safety or effectiveness of tezspire have been observed between patients 65 years of age and older and younger patients [see adverse reactions (6.1) and clinical studies (14)] .

European Union - English - EMA (European Medicines Agency)

tezspire

astrazeneca ab - tezepelumab - asthma - drugs for obstructive airway diseases, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.