saltzap 160 mg comprimido revestido por película - search results

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

zaltrap- ziv-aflibercept solution, concentrate

sanofi-aventis u.s. llc - aflibercept (unii: 15c2vl427d) (aflibercept - unii:15c2vl427d) - aflibercept 100 mg in 4 ml - zaltrap, in combination with fluorouracil, leucovorin, irinotecan-(folfiri), is indicated for the treatment of patients with metastatic colorectal cancer (mcrc) that is resistant to or has progressed following an oxaliplatin-containing regimen. none. risk summary based on findings from animal reproduction studies and its mechanism of action [see clinical pharmacology (12.1)] , zaltrap can cause fetal harm when administered to pregnant women. there is insufficient data in pregnant women exposed to zaltrap to assess the risks. administration of ziv-aflibercept during the period of organogenesis was embryotoxic and teratogenic in rabbits at exposure levels approximately 0.3 times the human exposure at the 4 mg per kg dose (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% to 4% and 15% to 20%, respectively. data animal data in pregnant rabbits, administration of ziv-aflibercept during the period of organogenesis resulted in an increase in postimplantation loss and external (including anasarca, umbilical hernia, diaphragmatic hernia and gastroschisis, cleft palate, ectrodactyly, and anal atresia), visceral (heart, great vessels, and arteries), and skeletal fetal malformations (including fused vertebrae, sternebrae, and ribs, supernumerary arches and ribs, and incomplete ossification) at doses greater than or equal to 3 mg per kg, administered once every 3 days (approximately 0.3 times the human exposure at the 4 mg per kg dose based on auc). risk summary there are no data on the presence of ziv-aflibercept in human milk, or the effects of ziv-aflibercept on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with zaltrap and for 1 month following the last dose. zaltrap can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status in females of reproductive potential prior to initiating zaltrap [see use in specific populations (8.1)] . contraception females based on data from animal studies and its mechanism of action, zaltrap can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with zaltrap and for 3 months following the last dose. infertility advise female and male patients of reproductive potential that zaltrap may impair reproductive function and fertility [see nonclinical toxicology (13.1)] . the safety and effectiveness in pediatric patients have not been established. safety and efficacy were assessed, but not established in a dose-escalation, safety, and tolerability study (nct00622414) in 21 patients with solid tumors 2 to 21 years of age (median age 12.9). the mean elimination half-life of free ziv-aflibercept determined after the first dose in 8 pediatric patients aged 5 to 17 years was within the range of values previously observed in adults. the maximum tolerated dose based on body weight in these pediatric patients was lower than the dose known to be safe and effective in adults with mcrc. juvenile animal toxicity data weekly/every-two-weeks intravenous administration of ziv-aflibercept at dose of 3 mg per kg (approximately 0.6 times the human exposure at the 4 mg per kg dose based on auc) to growing young adult (sexually mature) cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and the axial and appendicular skeleton), nasal cavity (atrophy/loss of the septum and/or turbinates), kidney (glomerulopathy with inflammation), ovary (decreased number of maturing follicles, granulosa cells, and/or theca cells), and adrenal gland (decreased vacuolation with inflammation). in another study in sexually immature cynomolgus monkeys (treated intravenously for 3 months), there were similar effects. the skeletal and nasal cavity effects were not reversible after a post-dosing recovery period. of the 611 patients with mcrc, patients treated with zaltrap/folfiri, 205 (34%) were 65 years or older, and 33 (5%) were 75 years or older. elderly patients (≥65 years of age) experienced higher incidences (≥5%) of diarrhea, dizziness, asthenia, weight decrease, and dehydration when compared to younger patients. monitor elderly patients more closely for diarrhea and dehydration [see warnings and precautions (5.9)]. the effect of zaltrap on overall survival was similar in patients <65 years old and ≥65 years old who received zaltrap/folfiri. no dosage modification is recommended for patients with renal impairment [see clinical pharmacology (12.3)] . no dosage modification is recommended for patients with mild (total bilirubin >1 to 1.5 times upper limit normal [uln] and any aspartate transaminase [ast]) and moderate (total bilirubin >1.5 to 3 times uln and any ast) hepatic impairment [see clinical pharmacology (12.3)] . zaltrap has not been studied in patients with severe hepatic impairment (total bilirubin >3 times uln and any ast).

New Zealand - English - Medsafe (Medicines Safety Authority)

zaltrap

sanofi-aventis new zealand limited - aflibercept 25 mg/ml; - concentrate for infusion - 25 mg/ml - active: aflibercept 25 mg/ml excipient: citric acid dibasic sodium phosphate heptahydrate hydrochloric acid monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride sodium citrate dihydrate sodium hydroxide sucrose water for injection - zaltrap in combination with irinotecan-fluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

New Zealand - English - Medsafe (Medicines Safety Authority)

zaltrap