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

sanofi-aventis australia pty ltd - vandetanib -

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

sanofi-aventis australia pty ltd - vandetanib, quantity: 100 mg - tablet, film coated - excipient ingredients: titanium dioxide; hypromellose; magnesium stearate; crospovidone; povidone; macrogol 300; calcium hydrogen phosphate dihydrate; microcrystalline cellulose - for the treatment of patients with symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

USA - engelsk - NLM (National Library of Medicine)

genzyme corporation - vandetanib (unii: yo460oq37k) (vandetanib - unii:yo460oq37k) - vandetanib 100 mg - caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. do not use in patients with congenital long qt syndrome [see boxed warning] . risk summary based on its mechanism of action and findings in animals, caprelsa can cause fetal harm when administered to a pregnant woman. there are no available human data on caprelsa use in pregnant women to inform a drug-associated risk. vandetanib is embryotoxic, fetotoxic, and induced fetal malformations in rats at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. advise patients of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in reproductive toxicity studies, administration of vandetanib to female rats prior to mating and through the first week of pregnancy at a dose of 25 mg/kg/day (approximately equal to the human exposure at the 300 mg clinical dose based on cmax ), there were increases in pre-implantation loss and post-implantation loss resulting in a reduction in the number of live embryos. during organogenesis, vandetanib caused an increase in post-implantation loss, including occasional total litter loss at a dose of 25 mg/kg/day. at doses greater than 10 mg/kg/day (approximately 0.4 times the human cmax at the 300 mg clinical dose) treatment with vandetanib resulted in increases in late embryofetal death and decreases in fetal birth weight. a no-effect level for malformations was not identified in this study. administration of vandetanib at doses greater than or equal to 1 mg/kg/day (approximately 0.03 times the human cmax at the 300 mg clinical dose) resulted in dose dependent increases in both malformations of the heart vessels and skeletal variations including delayed ossification of the skull, vertebrae, and sternum, indicating delayed fetal development. in a rat prenatal and postnatal development study, at doses (1 and 10 mg/kg/day) producing mild maternal toxicity during gestation and/or lactation, vandetanib decreased pup survival and reduced postnatal pup growth. reduced postnatal pup growth was associated with a delay in physical development. risk summary there are no data on the presence of vandetanib or its metabolites in human milk, the effects on the breastfed child or on milk production. vandetanib was present in the milk of lactating rats (see data) . because of the potential for serious adverse reactions from caprelsa in breastfed children, advise lactating women not to breastfeed during treatment with caprelsa and for 4 months after the last dose. data animal data in nonclinical studies, vandetanib was excreted in rat milk and found in plasma of pups following dosing to lactating rats. vandetanib transfer in breast milk resulted in relatively constant exposure in pups due to the long half-life of the drug. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating treatment with caprelsa [see use in specific populations (8.1)] . contraception caprelsa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with caprelsa and for 4 months after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with caprelsa and for 4 months after the last dose. infertility there are no data on the effect of caprelsa on human fertility. results from animal studies indicate that vandetanib can impair male and female fertility [see nonclinical toxicology (13.1)] . safety and efficacy of caprelsa in pediatric patients have not been established. the mtc study of caprelsa did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently compared to younger patients. vandetanib exposure is increased in patients with impaired renal function. reduce the starting dose to 200 mg in patients with moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment [see dosage and administration (2.1), warnings and precautions (5.12), and clinical pharmacology (12.3)] . vandetanib is not recommended for use in patients with severe renal impairment (clearance below 30 ml/min) [see warnings and precautions (5.12)] . patients with end-stage renal disease requiring dialysis were not studied [see adverse reactions (6.1)] . the pharmacokinetics of caprelsa were evaluated after a single dose of 800 mg in subjects with mild (n=8), moderate (n=7), and severe (n=6) hepatic impairment and normal hepatic function (n=5). subjects with mild (child-pugh class a), moderate (child-pugh class b), and severe (child-pugh class c) hepatic impairment had comparable mean auc and clearance values to those with normal hepatic function. there are limited data in patients with liver impairment (serum bilirubin greater than 1.5 times the upper limit of normal). caprelsa is not recommended for use in patients with moderate and severe hepatic impairment, as safety and efficacy have not been established [see dosage and administration (2.1) and warnings and precautions (5.13)] .

USA - engelsk - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - vandetanib (unii: yo460oq37k) (vandetanib - unii:yo460oq37k) - vandetanib 100 mg - caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. do not use in patients with congenital long qt syndrome [see boxed warning ]. pregnancy category d [see warnings and precautions (5.14) ] risk summary based on its mechanism of action, caprelsa can cause fetal harm when administered to a pregnant woman. vandetanib is embryotoxic, fetotoxic, and teratogenic in rats, at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. if caprelsa is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. animal data when vandetanib was administered to female rats prior to mating and through the first week of pregnancy at a do

Israel - engelsk - Ministry of Health

sanofi israel ltd - vandetanib - film coated tablets - vandetanib 100 mg - vandetanib - caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (mtc) in patients with unresectable locally advanced or metastatic disease. for patients in whom rearranged during transfection (ret) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

Den europeiske union - ungarsk - EMA (European Medicines Agency)

sanofi b.v. - vandetanib - pajzsmirigy daganatok - daganatellenes és immunmoduláló szerek - caprelsa javallt a kezelés a betegek inoperábilis helyileg előrehaladott vagy metasztatikus betegség agresszív és tüneti medullaris pajzsmirigy-rák (mtc). caprelsa jelzi a felnőttek, gyermekek, serdülők 5 éves kortól. azoknál a betegeknél, akiknél átrendezték-alatt-transfection(ret) a mutáció nem ismert, vagy negatív, egy esetleges alacsonyabb javára kell figyelembe venni, mielőtt egyéni kezelés határozat.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

sanofi b.v. - vandetanib - neoplażmi tat-tirojde - aġenti antineoplastiċi u immunomodulanti - caprelsa huwa indikat għat-trattament ta 'kanċer tat-tirojde mediterrali (mtc) aggressiv u sintomatiku f'pazjenti b'mard ta' lokalizzazzjoni avvanzat jew metastatiku li ma jistax jitneħħa. caprelsa huwa indikat fl-adulti, it-tfal u l-adolexxenti li għandhom bejn 5-il sena u anzjani. għal pazjenti li għalihom rranġati mill-ġdid il-waqt il-trasfezzjoni(ret) mutazzjoni mhux magħrufa jew negattiv, jista'jkun aktar baxxi benefiċċju għandu jkun kkunsidrat qabel it-trattament individwali id-deċiżjoni tal -.

Den europeiske union - litauisk - EMA (European Medicines Agency)

sanofi b.v. - vandetanib - skydliaukės navikai - antinavikiniai ir imunomoduliatoriai - caprelsa vartojamas agresyviam ir simptominiam meduliariniam skydliaukės vėžiui gydyti (mtc) pacientams, sergantiems nerezekuojama vietine progresavusia arba metastazine liga. caprelsa yra nurodyta suaugusiesiems, vaikams ir paaugliams nuo 5 metų ir vyresni. pacientams, kuriems pakartotinai išdėstyti-per-transfection(ret) mutacijos nėra žinoma, ar yra neigiamas, įmanoma mažesnės naudos turėtų būti atsižvelgiama į prieš individualų gydymą sprendimas.

Den europeiske union - rumensk - EMA (European Medicines Agency)

sanofi b.v. - vandetanib - neoplasme tiroidiene - agenți antineoplazici și imunomodulatori - caprelsa este indicat pentru tratamentul cancerului tiroidian medular agresiv și simptomatic (mtc) la pacienții cu boală inoperabilă la nivel local avansat sau metastatic. caprelsa este indicat la adulți, copii și adolescenți cu vârsta de 5 ani și mai în vârstă. pentru pacienții la care re-aranjate-timpul-transfecție(ret) mutație nu este cunoscut sau este negativ, posibil mai mic beneficiu ar trebui să fie luate în considerare înainte de tratament individual decizie.

Sveits - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

sanofi-aventis (suisse) sa - vandetanibum - filmtabletten - vandetanibum 100 mg, calcii hydrogenophosphas dihydricus, cellulosum microcristallinum, crospovidonum, povidonum k 29-32, magnesii stearas, pellicule: hypromellosum, macrogolum 300, e 171, pro compresso obducto. - medullären schilddrüsenkarzinoms - synthetika