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

blueprint medicines corporation - avapritinib (unii: 513p80b4yj) (avapritinib - unii:513p80b4yj) - ayvakit® is indicated for the treatment of adults with unresectable or metastatic gist harboring a platelet-derived growth factor receptor alpha (pdgfra) exon 18 mutation, including pdgfra d842v mutations [see dosage and administration (2.2)] . ayvakit is indicated for the treatment of adult patients with advanced systemic mastocytosis (advsm). advsm includes patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with an associated hematological neoplasm (sm-ahn), and mast cell leukemia (mcl). limitations of use : ayvakit is not recommended for the treatment of patients with advsm with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . ayvakit is indicated for the treatment of adult patients with indolent systemic mastocytosis (ism). limitations of use : ayvakit is not recommended for the treatment of patients with ism with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , ayvakit can cause fetal harm when administered to a pregnant woman. there are no available data on ayvakit use in pregnant women. oral administration of avapritinib to pregnant rats during the period of organogenesis was teratogenic and embryotoxic at exposure levels approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively (see data) . advise pregnant women 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 2-4% and 15-20%, respectively. data animal data in a reproductive toxicity study, administration of avapritinib to rats during the period of organogenesis resulted in decreased fetal body weights, post-implantation loss, and increases in visceral (hydrocephaly, septal defect, and stenosis of the pulmonary trunk) and skeletal (sternum) malformations at doses greater than or equal to 10 mg/kg/day (approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively). risk summary there are no data on the presence of avapritinib or its metabolites in human milk or the effects of avapritinib on the breastfed child or milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ayvakit and for 2 weeks following the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating ayvakit [see use in specific populations (8.1)] . contraception ayvakit can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)]. females advise females of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. infertility females based on findings from animal studies, ayvakit may impair female fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)]. males based on findings from animal studies, ayvakit may impair male fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)] . the safety and effectiveness of ayvakit in pediatric patients have not been established. of the 204 patients with unresectable or metastatic gist who received ayvakit in navigator, 40% were 65 years or older, while 6% were 75 years and older. of the 131 patients with advsm who received ayvakit in explorer and in pathfinder, 62% were 65 years or older, while 21% were 75 years and older. of the 141 patients with ism who received ayvakit in pioneer, 6% were 65 years or older, while <1% were 75 years and older. no overall differences in safety or efficacy were observed between these patients and younger adult patients. no dose adjustment is recommended for patients with mild or moderate renal impairment [creatinine clearance (clcr) 30 to 89 ml/min estimated by cockcroft-gault]. the recommended dose of ayvakit has not been established for patients with severe renal impairment (clcr 15 to 29 ml/min) or end-stage renal disease (clcr <15 ml/min) [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with mild [total bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or total bilirubin > 1 to 1.5 times uln and any ast], or moderate [total bilirubin >1.5 to 3 times uln and any ast] hepatic impairment. unbound auc0-inf was 61% higher in subjects with severe hepatic impairment (child-pugh class c) as compared to matched healthy subjects with normal hepatic function. a lower starting dose is recommended in patients with severe hepatic impairment [see dosage and administration (2.7)] .

European Union - English - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinal stromal tumors - other antineoplastic agents, protein kinase inhibitors - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Malta - English - Medicines Authority

pharmacare premium limited hhf 003 halfar industrial estate birzebbugia bbg 3000, malta - hard capsule - sunitinib 12.5 mg - antineoplastic agents

Malta - English - Medicines Authority

pharmacare premium limited hhf 003 halfar industrial estate birzebbugia bbg 3000, malta - hard capsule - sunitinib 25 mg - antineoplastic agents

Malta - English - Medicines Authority

pharmacare premium limited hhf 003 halfar industrial estate birzebbugia bbg 3000, malta - hard capsule - sunitinib 37.5 mg - antineoplastic agents

Malta - English - Medicines Authority

pharmacare premium limited hhf 003 halfar industrial estate birzebbugia bbg 3000, malta - hard capsule - sunitinib 50 mg - antineoplastic agents

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

lupin pharmaceuticals, inc. - lapatinib ditosylate (unii: g873gx646r) (lapatinib - unii:0vua21238f) - lapatinib is a kinase inhibitor indicated in combination with: (1) - capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (her2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.        limitations of use: patients should have disease progression on trastuzumab prior to initiation of treatment with  lapatinib tablets  in combination with capecetabine. - letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the her2 receptor for whom hormonal therapy is indicated. lapatinib tablets in combination with an aromatase inhibitor have not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. lapatinib tablets are contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. risk summary based on findings in animal studies and its mechanism of action, lapatinib tablets can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available human data to inform of the drug-associated risks. in an animal reproduction study, administration of lapatinib to pregnant rats during organogenesis and through lactation led to death of offspring within the first 4 days after birth at maternal exposures that were ≥ 3.3 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine. when administered to pregnant animals during the period of organogenesis, lapatinib caused fetal anomalies (rats) or abortions (rabbits) at maternally toxic doses. (see data) advise pregnant women and females of reproductive potential of the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of lapatinib at 30, 60, and 120 mg/kg/day during the period of organogenesis. minor anomalies (left-sided umbilical artery, cervical rib, and precocious ossification) occurred in rats at the maternally toxic dose of 120 mg/kg/day (approximately 6.4 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine). in rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (approximately 0.07 and 0.2 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) and abortions at 120 mg/kg/day. maternal toxicity was associated with decreased fetal body weights and minor skeletal variations. in a pre- and post-natal development study, rats were given oral doses of 20, 60, and 120 mg/kg/day during gestation through lactation up to weaning. in rats, doses of 60 and 120 mg/kg/day (approximately 3.3 and 6.4 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) led to decrease in f1 postnatal survival (91% and 34% of the pups died by the fourth day after birth, at 60 and 120 mg/kg/day, respectively). risk summary there are no data on the presence of lapatinib in human milk, or its effects on the breastfed child, or milk production. because of the potential for serious adverse reactions in a breastfed child from lapatinib tablets, advise lactating women not to breastfeed during treatment with lapatinib tablets and for 1 week after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of lapatinib tablets. contraception females based on findings in animal studies, lapatinib tablets 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 lapatinib tablets and for 1 week after the last dose. males based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with lapatinib tablets and for 1 week after the last dose[see use in specific populations (8.1)]. the safety and effectiveness of lapatinib tablets in pediatric patients have not been established of the total number of metastatic breast cancer patients in clinical studies of lapatinib tablets in combination with capecitabine (n = 198), 17% were 65 years of age and older, and 1% were 75 years of age and older. of the total number of hormone receptor-positive, her2-positive  metastatic breast cancer patients in clinical studies of lapatinib tablets in combination with letrozole  (n = 642), 44% were 65 years of age and older, and 12% were 75 years of age and older. no overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing hemodialysis. there is no experience with lapatinib tablets in patients with severe renal impairment. however, renal impairment is unlikely to affect the pharmacokinetics of lapatinib given that less than 2% (lapatinib and metabolites) of an administered dose is eliminated by the kidneys. the pharmacokinetics of lapatinib were examined in subjects with pre-existing moderate (n = 8) or severe (n = 4) hepatic impairment (child-pugh class b/c, respectively) and in 8 healthy control subjects. systemic exposure (auc) to lapatinib after a single oral 100-mg dose increased approximately 14% and 63% in subjects with moderate and severe preexisting hepatic impairment, respectively. administration of lapatinib tablets in patients with severe hepatic impairment should be undertaken with caution due to increased exposure to the drug. a dose reduction should be considered for patients with severe preexisting hepatic impairment [see dosage and administration (2.2)] . in patients who develop severe hepatotoxicity while on therapy, lapatinib tablets should be discontinued and patients should not be retreated with lapatinib tablets [see warnings and precautions (5.2)] .

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

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials).

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - aprotinin - solution for injection - aprotinin 500,000/50 kiu/ml - antihemorrhagics

Malta - English - Medicines Authority

miller and miller chemicals unit 3, burnside industrial est, 49-53 roebuck road hainault, essex ig63ug, united kingdom - aprotinin - solution for injection - aprotinin 10,000 kiu/ml - antihemorrhagics