Israel - English - Ministry of Health

medison pharma ltd - fostamatinib as disodium hexahydrate - film coated tablets - fostamatinib as disodium hexahydrate 100 mg - fostamatinib - tavalisse is indicated for the treatment of chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments.

Israel - English - Ministry of Health

medison pharma ltd - fostamatinib as disodium hexahydrate - film coated tablets - fostamatinib as disodium hexahydrate 150 mg - fostamatinib - tavalisse is indicated for the treatment of chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments.

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

arrow pharma pty ltd - meloxicam -

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

arrow pharma pty ltd - meloxicam -

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

arrow pharma pty ltd - meloxicam -

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

arrow pharma pty ltd - meloxicam -

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

rigel pharmaceuticals, inc. - fostamatinib (unii: sq8a3s5101) (fostamatinib - unii:sq8a3s5101) - tavalisse is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (itp) who have had an insufficient response to a previous treatment. none. risk summary based on findings from animal studies and the mechanism of action, tavalisse can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of fostamatinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes that were directly attributed to exposure in utero to the major fostamatinib metabolite (r406) at maternal exposures (auc) as low as 0.3 and 10 times the exposure in patients at the maximum recommended human dose (mrhd), respectively (see data). advise pregnant women of the potential risk to a fetus. 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 2-4% and 15-20%, respectively. an estimated background risk of major birth defects and miscarriage for the chronic itp population is 8% and 4-11%, respectively. data animal data in a fertility and early embryonic development study in female rats, fostamatinib was administered orally for 15 days before mating to day 7 of pregnancy, which caused a slight decrease in pregnancy rates and an increase in post-implantation loss were seen at maternal doses approximately 4.2 times the dose in patients at the mrhd. in embryo-fetal development studies, pregnant animals were orally administered fostamatinib during the period of organogenesis at doses up to 25 and 50 mg/kg/day in rats and rabbits, respectively. the adverse developmental outcomes included an increase in embryo-fetal mortality (post-implantation loss), alterations to growth (lower fetal weights), and structural abnormalities (variations and malformations). these effects occurred at maternal exposures (aucs) of 3,763 ng.h/ml in rats and 111,105 ng.h/ml in rabbits that were approximately 0.3 and 10 times the human exposure at the mrhd in rats and rabbits, respectively. in a peri and postnatal development study in rats, fostamatinib was orally administered at doses of 2.5, 12.5, and 25 mg/kg/day from gestation day 7 until lactation day 20. the dose of 25 mg/kg/day was associated with maternal toxicity, including decreased body weights, body weight gains, and food consumption. at doses as low as 12.5 mg/kg/day fostamatinib caused increases in newborn mortality (neonatal mortality), alterations in growth and/or development (lower neonatal weights into post-weaning and structural abnormalities [malformations]). functional impairment (delayed sexual maturation) was observed at 25 mg/kg/day. there was no evidence of neurobehavioral defects (maze learning and shuttle box avoidance) or immunological compromise (influenza host resistance challenge) in the f1 generation or latent untoward effects in the f2 generation. the maternal doses were approximately 2.1 and 4.2 times the mhrd in patients. risk summary there are no data on the presence of fostamatinib and/or its metabolites in human milk, the effects on the breastfed child, or on milk production. in rodents, r406 (the major active metabolite) was detected in maternal milk in concentrations 5- to 10-fold higher than in maternal plasma. because of the potential for serious adverse reactions in a breastfed child from tavalisse, advise a lactating woman not to breastfeed during treatment with tavalisse and for at least 1 month after the last dose. pregnancy testing based on animal studies, tavalisse can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . for females of reproductive potential, verify pregnancy status prior to initiating tavalisse. contraception females based on animal studies, tavalisse can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with tavalisse and for at least 1 month after the last dose. infertility there are no data on the effect of tavalisse on human fertility. based on the finding of reduced pregnancy rates in animal studies, tavalisse may affect female fertility [see use in specific populations (8.1)] . safety and effectiveness in pediatric patients have not been established. tavalisse is not recommended for use in patients less than 18 years of age because adverse effects on actively growing bones were observed in nonclinical studies. in subchronic, chronic, and carcinogenicity studies of tavalisse, chondrodystrophy of the femoral head was seen in rodents. in a study in juvenile rabbits, growth plate dysplasia was observed in the proximal femur and femoro-tibial joint, and bone marrow cellularity was reduced in the femur and sternum. of the 102 patients with itp who received tavalisse, 28 (27%) were 65 years of age and older, while 11 (11%) were 75 years of age and older. in patients 65 years of age and older, 6 (21%) patients experienced serious adverse events and 5 (18%) experienced adverse events leading to treatment withdrawal while in patients under 65 years of age, 7 (9%) and 5 (7%) experienced serious adverse events and adverse events leading to treatment withdrawal, respectively. in patients 65 years of age and older who received tavalisse, 11 (39%) patients experienced hypertension versus 2 (18%) placebo compared to 17 (23%) in patients under 65 of age versus 4 (11%) placebo. no overall differences in effectiveness were observed in these patients compared to younger patients.

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

aspen pharma pty ltd - meloxicam -

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

aspen pharma pty ltd - meloxicam -

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

aspen pharma pty ltd - meloxicam -