Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - daclizumab -

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

provention bio, inc. - teplizumab (unii: s4m959u2ij) (teplizumab - unii:s4m959u2ij) - tzield is indicated to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with stage 2 type 1 diabetes [see dosage and administration (2.1)] . none. risk summary available case reports from clinical trials with tzield are insufficient to identify a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. although there are no data on teplizumab-mzwv, monoclonal antibodies can be actively transported across the placenta, and tzield may cause immunosuppression in the utero- exposed infant (see clinical considerations). to minimize exposure to a fetus, avoid use of tzield during pregnancy and at least 30 days (6 half-lives) prior to planned pregnancy. tzield is not active in rodents. in animal reproduction studies, mice were given a surrogate anti-mouse cd3 antibody subcutaneously during organogenesis through lactation. pups born to dams administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. report pregnancies to provention bio, inc.'s adverse event reporting line at 1-800-633-1610. clinical considerations fetal/neonatal adverse reactions transport of endogenous igg antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. because teplizumab-mzwv may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. there are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab- mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero. data animal data in an embryo-fetal developmental toxicity study, pregnant mice were administered a murine surrogate anti-mouse cd3 antibody by subcutaneous injection at dose levels of 0, 0.03, 0.3, or 20 mg/kg on gestation days 6, 10, and 14. increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity. in a pre- and postnatal development toxicity study in pregnant mice, in which the murine surrogate antibody was administered every 3 days from gestation day 6 through lactation day 19 at doses of 0, 0.3, 3, or 20 mg/kg, no maternal toxicity or increased incidence of post- implantation loss was observed. reductions in t cell populations and increases in b cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (klh) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. the surrogate antibody was present in the offspring serum at level less than 1.5% that of maternal serum at the high dose. a trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg. the human relevance of this finding is unknown. risk summary there are no data on the presence of teplizumab-mzwv in either human or animal milk, the effects on the breastfed child, or the effects on milk production. endogenous maternal igg and monoclonal antibodies are transferred into human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to teplizumab-mzwv are unknown. although the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tzield and any potential adverse effects on the breastfed child from tzield or from the underlying maternal condition, a lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after tzield administration to minimize drug exposure to a breastfed child. the safety and effectiveness of tzield to delay the onset of stage 3 type 1 diabetes have been established in pediatric patients 8 years of age and older with stage 2 type 1 diabetes. use of tzield for this indication is supported by evidence from an adequate and well-controlled study (study tn-10) in adults and pediatric patients 8 years of age and older (including 29 pediatric patients). adverse reactions observed in pediatric patients 8 years of age and older who received tzield were consistent with those reported in adult patients [see adverse reactions (6.1)] . the safety and effectiveness of tzield have not been established in pediatric patients younger than 8 years of age. stage 2 type 1 diabetes is largely a condition that occurs in pediatric and younger adult patients. clinical studies of tzield to delay the onset of stage 3 t1d did not include patients 65 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

Israel - English - Ministry of Health

teva israel ltd - reslizumab - concentrate for solution for infusion - reslizumab 10 mg / 1 ml - reslizumab - cinqair is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see clinical studies (14)].limitation of use:• cinqair is not indicated for treatment of other eosinophilic conditions.• cinqair is not indicated for the relief of acute bronchospasm or status asthmaticus

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - omalizumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: omalizumab 150 mg/ml   excipient: arginine hydrochloride histidine histidine hydrochloride monohydrate polysorbate 20 water for injection - xolair (omalizumab) is indicated for the reduction of asthma exacerbations and control of asthma symptoms when given as add-on therapy for adult and adolescent patients, 6 years and older, with severe persistent allergic asthma who have ige greater than or equal to 30 iu/ml, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - omalizumab 150 mg/ml;   - solution for injection - 75 mg/0.5ml - active: omalizumab 150 mg/ml   excipient: arginine hydrochloride histidine histidine hydrochloride monohydrate polysorbate 20 water for injection - xolair (omalizumab) is indicated for the reduction of asthma exacerbations and control of asthma symptoms when given as add-on therapy for adult and adolescent patients, 6 years and older, with severe persistent allergic asthma who have ige greater than or equal to 30 iu/ml, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - reslizumab -

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - reslizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: sodium acetate trihydrate; glacial acetic acid; water for injections; sucrose - cinqair is indicated as add-on therapy in adult patients with severe eosinophilic asthma (blood eosinophil count greater than or equal to 400 cells/?l) (see clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - daclizumab -