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

opko pharmaceuticals llc - calcifediol (unii: p6yz13c99q) (calcifediol anhydrous - unii:t0wxw8f54e) - calcifediol 30 ug - rayaldee is a vitamin d3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin d levels less than 30 ng/ml. limitations of use rayaldee is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis. none. there are no human data with calcifediol use in pregnant women to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see clinical considerations) . in animal reproduction studies, calcifediol increased skeletal and soft tissue malformation when rabbits were given once daily oral doses representing ≥8 times the human dose of 60 mcg/day, based on body surface area (mg/m2 ), during the period of organogenesis. no adverse developmental effects were observed in rats given up to 10 times the human dose, based on body surface area (mg/m2 ), during organogenesis. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, miscarriage, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. animal data calcifediol was given orally to pregnant rats and rabbits during the period of organogenesis (in rats, from gestation day [gd] 6 to 15; in rabbits, from gd 6 to 18). rats were given 0, 12, 40, 60 mcg/kg/day; and rabbits were given 0, 5, 25, 50 mcg/kg/day, representing up to 10 and 16 times, respectively, a human dose of 60 mcg/day, based on body surface area (mg/m2 ). in rats, no adverse developmental effects were observed at calcifediol doses up to 60 mcg/kg/day. in rabbits, increased incidences of domed skull, enlarged atrium of the heart, and dilatation of pulmonary artery, were observed at doses of 25 and 50 mcg/kg/day (representing 8 and 16 times the human dose of 60 mcg/day, respectively, based on body surface area (mg/m2 ). rats were given calcifediol during the pre/postnatal period (gd 15 to weaning). no adverse effects on gestation, parturition, lactation or survival of offspring were observed at calcifediol doses up to 60 mcg/kg/day. there is no information available on the presence of calcifediol in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. infants potentially exposed to calcifediol through breast milk should be monitored for signs and symptoms of hypercalcemia (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rayaldee and any potential adverse effects on the breastfed child from rayaldee or from the underlying maternal condition. monitor infants exposed to calcifediol through breast milk for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss. consider monitoring of serum calcium in the infant. the safety and efficacy of rayaldee have not been established in pediatric patients. of the total number of subjects in phase 3 placebo-controlled clinical studies of rayaldee, 63% were ≥65 years of age and 22% were ≥75 years of age. no overall differences in the safety or efficacy of rayaldee were observed between subjects older than 65 years and younger subjects. no difference in efficacy was observed between patients with stage 3 chronic kidney disease or those with stage 4 disease in subgroup analysis. safety outcomes were similar in these subgroups. the safety and efficacy of rayaldee in the treatment of secondary hyperparathyroidism in patients with stage 2 or stage 5 chronic kidney disease and patients with end-stage renal disease on dialysis have not been established [see indications and usage (1) ].

Ireland - English - HPRA (Health Products Regulatory Authority)

vifor fresenius medical care renal pharma france - calcifediol - prolonged-release capsule, soft - 30 microgram(s) - calcifediol; other anti-parathyroid agents

Ireland - English - HPRA (Health Products Regulatory Authority)

nordic pharma limited - calcifediol monohydrate - capsule, soft - calcifediol

Canada - English - Health Canada

eirgen pharma limited - calcifediol - capsule - 30mcg - calcifediol 30mcg - vitamin d

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

bio-practica pty ltd - calcifediol monohydrate, quantity: 0.01 mg - tablet, uncoated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; crospovidone; starch sodium octenyl succinate; sodium ascorbate; dl-alpha-tocopherol; sucrose; medium chain triglycerides - maintain/support general health and wellbeing ; maintain/support healthy teeth ; maintain/support bone health ; aids/assists healthy bone development/growth/building ; vitamin d helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life ; maintain/support heart health ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle health ; maintain/support muscle function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; maintain/support neuromuscular function ; maintain/support nervous system health

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

faes farma - calcifediol - capsule, soft - 0,266 mg - calcifediol 0.266 mg - calcifediol

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

laboratorio farmaceutico s.i.t. s.r.l. - calcifediol 0,15 mg/ml - oral drops, solution - 0,15 mg/ml - calcifediol 0.15 mg/ml - calcifediol

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

faes farma - calcifediol - capsules - 0,266mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

faes farma, s.a. - calcifediol - calcifediol....0.266 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية نيروخ - nairoukh drug store - calcifediol 0.15 mg/ml - 0.15 mg/ml