Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clolar® (clofarabine) injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clolar. none pregnancy category d clolar (clofarabine) may cause fetal harm when administered to a pregnant woman. clofarabine was teratogenic in rats and rabbits. developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m2 /day (approximately equivalent to the recommended clinical dose on a mg/m2 basis), and in rabbits receiving 12 mg/m2 /day (approximately 23% of the recommended clinical dose on a mg/m2 basis). there are no adequate and well-controlled studies in pregnant women usin

Bandaríkin - enska - NLM (National Library of Medicine)

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).

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - docetaxel (unii: 15h5577cqd) (docetaxel anhydrous - unii:699121phca) - docetaxel anhydrous 20 mg in 1 ml - taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. taxotere as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. taxotere in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. taxotere in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesopha

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - arava is indicated for the treatment of adults with active rheumatoid arthritis (ra). arava is contraindicated in: - pregnant women. arava may cause fetal harm. if a woman becomes pregnant while taking this drug, stop arava, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1, 5.3) and use in specific populations (8.1)] . - patients with severe hepatic impairment [see warnings and precautions (5.2)] . - patients with known hypersensitivity to leflunomide or any of the other components of arava. known reactions include anaphylaxis [see adverse reactions (6.1)] . - patients being treated with teriflunomide [see drug interactions (7)] . pregnancy exposure registry there is a pregnancy exposure

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - cabazitaxel (unii: 51f690397j) (cabazitaxel - unii:51f690397j) - cabazitaxel 60 mg in 1.5 ml - jevtana® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. jevtana is contraindicated in patients with: - neutrophil counts of ≤1,500/mm3 [see warnings and precautions (5.1)] - history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see warnings and precautions (5.3)] - severe hepatic impairment (total bilirubin >3 × uln) [see warnings and precautions (5.8)] risk summary the safety and efficacy of jevtana have not been established in females. there are no human data on the use of jevtana in pregnant women to inform the drug-associated risk. in animal reproduction studies, intravenous administration of cabazitaxel in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than the maximum recommended human dose [see data] . data animal data in an early embryonic developmental toxicity stu

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - rasburicase (unii: 08gy9k1euo) (rasburicase - unii:08gy9k1euo) - rasburicase 1.5 mg in 1 ml - elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. limitations of use elitek is indicated only for a single course of treatment [see warnings and precautions (5.1)] . elitek is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase [see boxed warning, warnings and precautions (5.1, 5.2, 5.3)] . elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (g6pd) [see boxed warning, warnings and precautions (5.2)] . risk summary based on findings in animals, elitek may cause fetal harm when administered to pregnant women. in animal reproduction studies, intravenous administration of rasburicase to pregnant rabbits during organo

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - glimepiride (unii: 6ky687524k) (glimepiride - unii:6ky687524k) - glimepiride 1 mg - amaryl is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14.1)] . limitations of use amaryl should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. amaryl is contraindicated in patients with a history of a hypersensitivity reaction to: - glimepiride or any of the product's ingredients [see warnings and precautions (5.2)]. - sulfonamide derivatives: patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to amaryl. do not use amaryl in patients who have a history of an allergic reaction to sulfonamide derivatives. risk summary available data from a small number of published studies and postmarketing experience with amaryl use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. however, sulfonylureas (in

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - irbesartan (unii: j0e2756z7n) (irbesartan - unii:j0e2756z7n), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - irbesartan 150 mg - avalide® (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension. avalide may be used in patients whose blood pressure is not adequately controlled on monotherapy. avalide may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. the choice of avalide as initial therapy for hypertension should be based on an assessment of potential benefits and risks. patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. data from studies v and vi [see clinical studies (14.2)]

Bandaríkin - enska - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - irbesartan (unii: j0e2756z7n) (irbesartan - unii:j0e2756z7n) - irbesartan 75 mg - avapro® is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanis