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

avera mckennan hospital - anagrelide hydrochloride (unii: vns4435g39) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

kent pharmaceuticals limited - anagrelide - capsules hard - 0.5 milligram - anagrelide

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

arrotex pharmaceuticals pty ltd - anagrelide hydrochloride, quantity: 0.61 mg (equivalent: anagrelide, qty 0.5 mg) - capsule, hard - excipient ingredients: lactose; povidone; crospovidone; microcrystalline cellulose; lactose monohydrate; titanium dioxide; gelatin; magnesium stearate - anagrelide apotex capsules are indicated for the treatment of essential thrombocythaemia.

Ireland - English - HPRA (Health Products Regulatory Authority)

athlone laboratories ltd - anagrelide - capsule, hard - 0.5 milligram(s) - other antineoplastic agents; anagrelide

Canada - English - Health Canada

sandoz canada incorporated - anagrelide (anagrelide hydrochloride monohydrate) - capsule - 0.5mg - anagrelide (anagrelide hydrochloride monohydrate) 0.5mg - platelet-reducing agents

Ireland - English - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - anagrelide - capsule, hard - other antineoplastic agents; anagrelide

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

arrotex pharmaceuticals pty ltd - anagrelide hydrochloride, quantity: 0.61 mg (equivalent: anagrelide, qty 0.5 mg) - capsule, hard - excipient ingredients: gelatin; lactose; microcrystalline cellulose; crospovidone; titanium dioxide; povidone; magnesium stearate; lactose monohydrate - anagrelide neo health capsules are indicated for the treatment of essential thrombocythaemia.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - anagrelide hydrochloride - capsule - 500microgram

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - anagrelide hydrochloride 0,61 mg - eq. anagrelide 0,5 mg - capsule, hard - 0,5 mg - anagrelide hydrochloride 0.61 mg - anagrelide

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

takeda pharmaceuticals america, inc. - anagrelide hydrochloride anhydrous (unii: vns4435g39) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg - agrylin is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. none. risk summary available data from case reports with agrylin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area (see data) . there are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy (see clinical considerations). the estimated 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 risk of major birth defect 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 thrombotic events, such as stroke, deep vein thrombosis, or myocardial infarction, can be complications of thrombocythemia. thrombocythemia in pregnancy is associated with an increased risk for miscarriage, stillbirth, and other maternal outcomes, such as preeclampsia. data animal data anagrelide hydrochloride was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 900 mg/kg/day in rats and up to 20 mg/kg/day in rabbits (875 and 39 times, respectively, the maximum clinical dose of 10 mg/day based on body surface area). in rats, developmental delays were observed including reductions in fetal weight at 300 and 900 mg/kg/day and delays in skeletal ossification at doses of 100 mg/kg/day and higher. the dose of 100 mg/kg/day (600 mg/m2 /day) in rats is approximately 97 times the maximum clinical dose based on body surface area. no adverse embryo-fetal effects were detected in rabbits at the highest dose of 20 mg/kg/day (39 times the maximal clinical dose based on body surface area). in a pre- and post-natal study conducted in female rats, anagrelide hydrochloride administered at oral doses of 60 mg/kg/day (58 times the maximum clinical dose based on body surface area) or higher during organogenesis through lactation produced delay or blockage of parturition, deaths of non-delivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born. in a placental transfer study, a single oral dose of [14 c]-anagrelide hydrochloride (3 mg/kg) was administered to pregnant rats on gestation day 17. drug-related radioactivity was detected in maternal and fetal tissue. risk summary there is no information regarding the presence of anagrelide in human milk, the effect on the breastfed child, or the effects on milk production. anagrelide or its metabolites have been detected in the milk of lactating rats (see data) . because of the potential for serious adverse reactions, including thrombocytopenia, in a breastfed child, advise patients that breastfeeding is not recommended during treatment with agrylin, and for one week following the last dose. data in a rat milk secretion study, a single oral dose of [14 c]-anagrelide hydrochloride (3 mg/kg) was administered to lactating female rats on postnatal day 10. drug-related radioactivity was detected in the maternal milk and blood. infertility females based on findings from animal studies, agrylin may impair female fertility [see nonclinical toxicology (13.1)] . the safety and effectiveness of agrylin have been established in pediatric patients 7 years of age and older. there are no data for pediatric patients less than 7 years of age. use of agrylin in these pediatric patients is supported by evidence from adequate and well controlled studies of agrylin in adults with additional pharmacokinetic, pharmacodynamic, and safety data in 18 pediatric patients aged 7 through 16 years with thrombocythemia secondary to et [see dosage and administration (2.1), clinical pharmacology (12.3), and clinical studies (14)] . there were no apparent trends or differences in the types of adverse events observed between the pediatric patients compared with those of the adult patients [see adverse reactions (6.1)]. of the 942 subjects in clinical studies of agrylin, 42.1% were 65 years and over, while 14.9% were 75 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. hepatic metabolism is the major route of anagrelide clearance. exposure to anagrelide is increased 8-fold in patients with moderate hepatic impairment [see clinical pharmacology (12.3)] and dose reduction is required [see dosage and administration (2.3)] . use of agrylin in patients with severe hepatic impairment has not been studied. avoid use of agrylin in patients with severe hepatic impairment. the potential risks and benefits of agrylin therapy in a patient with mild and moderate hepatic impairment should be assessed before treatment is commenced. assess hepatic function before and during agrylin treatment [see warnings and precautions (5.1)] .