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

adjutor healthcare pty ltd - vadadustat, quantity: 150 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate type a; hypromellose; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - vafseo is indicated for the treatment of anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

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

adjutor healthcare pty ltd - vadadustat, quantity: 300 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; microcrystalline cellulose; hypromellose; silicon dioxide; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - vafseo is indicated for the treatment of anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

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

adjutor healthcare pty ltd - vadadustat, quantity: 450 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - vafseo is indicated for the treatment of anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Unione Europea - inglese - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemic preparations - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Unione Europea - inglese - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemic preparations - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Stati Uniti - inglese - NLM (National Library of Medicine)

akebia therapeutics, inc. - vadadustat (unii: i60w9520vv) (vadadustat - unii:i60w9520vv) - vafseo is indicated for the treatment of anemia due to chronic kidney disease (ckd) in adults who have been receiving dialysis for at least three months. limitations of use - vafseo has not been shown to improve quality of life, fatigue, or patient well-being. - vafseo is not indicated for use: as a substitute for red blood cell transfusions in patients who require immediate correction of anemia in patients with anemia due to ckd not on dialysis [see warnings and precautions (5.6)] . - as a substitute for red blood cell transfusions in patients who require immediate correction of anemia - in patients with anemia due to ckd not on dialysis [see warnings and precautions (5.6)] . vafseo is contraindicated in patients: - with a known hypersensitivity to vafseo or any of its components [see description (11)] . - with uncontrolled hypertension [see warnings and precautions (5.3)] . risk summary available data with vafseo use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with ckd (see clinical considerations) . vadadustat administration orally to pregnant rats and rabbits during the period of organogenesis was associated with reduced fetal weight at doses that caused maternal toxicity. in rat and rabbit studies, vadadustat was not teratogenic (see data) . the background risk of major birth defects and miscarriage 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. vafseo should only be used during pregnancy if the benefit justifies the potential risk to the fetus. clinical considerations disease-associated maternal and/or embryo/fetal risk: ckd in pregnancy increases the risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios. data animal data vadadustat decreased fetal weight and reduced fetal skeletal ossification in rats at a dose of 160 mg/kg/day (1.7 times the maximum recommended human dose [mrhd] based on auc), which was associated with maternal toxicity defined by reduced body weight gain and food consumption. vadadustat was orally administered to pregnant rabbits at doses of 10, 25, or 50 mg/kg/day from gestation day 6 until gestation day 18 during the period of organogenesis. vadadustat administration at 50 mg/kg/day resulted in maternal toxicity of reduced body weight gain, but no adverse effects on embryofetal development were observed at doses less than or equal to 50 mg/kg/day (1.5 times the mrhd based on auc). in a pre- and postnatal development study, pregnant rats were dosed orally with vadadustat 20, 40, or 80 mg/kg/day from implantation until weaning (gestation day 6 to lactation day 20) at 20, 40, or 80 mg/kg/day. there were decreased body weights of offspring at the dose of 80 mg/kg/day but no adverse effects were observed at doses less than or equal to 80 mg/kg/day (0.3 times the mrhd based on auc) in dams. risk summary there are no data on the presence of vadadustat in human milk, the effects of vadadustat on the breastfed child, or the effects on milk production. vadadustat is present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. given the serious adverse reactions seen in adults treated with vafseo, such as thrombotic vascular events, advise patients not to breastfeed during treatment with vafseo, and for 2 days after the final dose. data vadadustat was detected in the milk of lactating rats after a single oral administration of radiolabeled vadadustat at 50 mg/kg. the maximum ratio of milk to plasma concentration in rats was 14.5 at 8 hours postdose and the ratio of milk to plasma auc was 6. the safety and effectiveness of vafseo in pediatric patients have not been established. there were 1330 patients 65 years of age and older in the pooled inno2 vate-1 and inno2 vate-2 clinical trials. of the total number of vafseo-treated patients in these studies, 449 (23%) were 65 to 74 years of age, 194 (10%) were 75 to 84 years of age, and 24 (1%) were 85 years of age and older. no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients [see clinical studies (14.2)] . vafseo is not recommended in patients with cirrhosis or active, acute liver disease [see warnings and precautions (5.2)] . vafseo contains vadadustat, which is not a controlled substance. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. abuse of vafseo may be seen in athletes for the effects on erythropoiesis. abuse-related adverse reactions there are no data on the abuse of vafseo in humans. vadadustat and its metabolites neither selectively penetrate the central nervous system, nor produce behavioral effects in animals that are consistent with central nervous system activity. misuse of drugs that increase erythropoiesis, such as vafseo, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications (e.g., stroke, myocardial infarction, and thromboembolism).

Stati Uniti - inglese - NLM (National Library of Medicine)

similasan corporation - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), euphrasia stricta (unii: c9642i91wl) (euphrasia stricta - unii:c9642i91wl), calcium sulfide (unii: 1mbw07j51q) (calcium sulfide - unii:1mbw07j51q), platycladus orientalis leaf (unii: 32e5v7g32b) (platycladus orientalis leaf - unii:32e5v7g32b) - dryness, redness, burning redness, burning, watering sensation of grittiness, stinging irritation according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • redness of the eyes • irritation, dryness, and burning • sensation of grittiness • excessive watering (clear)

Stati Uniti - inglese - NLM (National Library of Medicine)

similasan corporation - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), euphrasia stricta (unii: c9642i91wl) (euphrasia stricta - unii:c9642i91wl), calcium sulfide (unii: 1mbw07j51q) (calcium sulfide - unii:1mbw07j51q), platycladus orientalis leaf (unii: 32e5v7g32b) (platycladus orientalis leaf - unii:32e5v7g32b) - dryness, redness, burning redness, burning, watering sensation of grittiness, stinging irritation according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • redness of the eyes • irritation, dryness, and burning • sensation of grittiness • excessive watering (clear)

Stati Uniti - inglese - NLM (National Library of Medicine)

similasan ag - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), euphrasia stricta (unii: c9642i91wl) (euphrasia stricta - unii:c9642i91wl), calcium sulfide (unii: 1mbw07j51q) (calcium sulfide - unii:1mbw07j51q), platycladus orientalis leaf (unii: 32e5v7g32b) (platycladus orientalis leaf - unii:32e5v7g32b) - dryness, redness, burning redness, burning, watering sensation of grittiness, stinging irritation according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • redness of the eyes • irritation, dryness, and burning • sensation of grittiness • excessive watering (clear)

Stati Uniti - inglese - NLM (National Library of Medicine)

similasan ag - atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), euphrasia stricta (unii: c9642i91wl) (euphrasia stricta - unii:c9642i91wl), calcium sulfide (unii: 1mbw07j51q) (calcium sulfide - unii:1mbw07j51q), platycladus orientalis leaf (unii: 32e5v7g32b) (platycladus orientalis leaf - unii:32e5v7g32b) - dryness, redness, burning redness, burning, watering sensation of grittiness, stinging irritation according to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • redness of the eyes • irritation, dryness, and burning • sensation of grittiness • excessive watering (clear)