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

zydus pharmaceuticals usa inc. - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine injection is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations). in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1,500

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

nexus pharmaceuticals llc - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine injection is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, nelarabine injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine injection use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal, or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations). in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1500 mg/m2 /day (see data) . advise pregnant women of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk there are risks to the mother from untreated leukemia or lymphoma, including anemia, thrombocytopenia, and death. data animal data in an embryo-fetal development study in which pregnant rabbits were administered daily doses of nelarabine during organogenesis, increased incidences of fetal malformations, anomalies, and variations were observed at doses greater than or equal to 360 mg/m2 /day (8-hour iv infusion; approximately 25% of the recommended human adult dose compared on a mg/m2 basis), which was the lowest dose tested. cleft palate was seen in rabbits given 3600 mg/m2 /day (approximately 2-fold the adult dose), absent pollices (digits) in rabbits given greater than or equal to 1200 mg/m2 /day (approximately 75% of the recommended adult dose), while absent gall bladder, absent accessory lung lobes, fused or extra sternebrae, and delayed ossification was seen at all doses. maternal body weight gain and fetal body weights were reduced in rabbits given 3600 mg/m2 /day (approximately 2-fold the adult dose), but could not account for the increased incidence of malformations seen at this or lower administered doses. risk summary there are no data on the presence of nelarabine or ara-g in human or animal milk, the effect on the breastfed child, or the effect on milk production. because of the potential for serious adverse reactions in the breastfed child from nelarabine injection, such as severe neurological reactions, advise women not to breastfeed during treatment with nelarabine injection. pregnancy testing nelarabine injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to starting treatment with nelarabine injection. contraception females nelarabine injection can cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.3), use in specific populations (8.1)] . because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with nelarabine injection. males because of the potential for genotoxicity, advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with nelarabine injection and for 3 months after the last dose [see nonclinical toxicology (13.1)] . the safety and effectiveness of nelarabine injection for relapsed or refractory t-all and t-lbl has been established in pediatric patients age 1 year and older. the effectiveness of nelarabine injection in pediatric patients is supported by one single-arm clinical trial, and safety has been asssessed in 165 pediatric patients age 1 year and older across multiple phase i and phase ii trials. the trial establishing efficacy included 84 patients age 21 years and younger, who had relapsed or refractory t-all or t-lbl. the most frequent adverse reactions of any grade occurring on treatment in this study were hematologic laboratory abnormalities. hematologic toxicity observed in the pediatric population was higher than that seen in the adult population [see dosage and administration (2.1), adverse reactions (6.1), clinical studies (14.2)]. nervous system adverse reactions have been reported for 42% of pediatric patients across the phase i and phase ii trials. the incidence of nervous system adverse reactions was less in the pediatric population than that seen in adult patients with relapsed/refractory t-all/t-lbl [see adverse reactions (6.1)] . in a phase iii study of nelarabine injection in combination with multi-agent chemotherapy as first-line therapy, there were 411 patients with t-all or t-lbl treated with nelarabine injection. the safety profile in the 357 patients age 1 to 16 years was consistent with that seen in older patients in the study [see adverse reactions (6.1)] . due to lack of long-term follow up data, a determination of the impact of nelarabine injection on the growth and pubertal development of pediatric patients cannot be made. clinical studies of nelarabine injection did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. in an exploratory analysis, increasing age, especially age 65 years and older, appeared to be associated with increased rates of neurologic adverse reactions. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see use in specific populations (8.6)] . ara-g clearance decreased as renal function decreased [see clinical pharmacology (12.3)] . because the risk of adverse reactions to this drug may be greater in patients with moderate (clcr 30 to 50 ml/min) or severe (clcr less than 30 ml/min) renal impairment, these patients should be closely monitored for toxicities when treated with nelarabine injection [see dosage and administration (2.3)] . the influence of hepatic impairment on the pharmacokinetics of nelarabine has not been evaluated. because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (total bilirubin greater than 3 times upper limit of normal), these patients should be closely monitored for toxicities when treated with nelarabine injection.

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

zydus pharmaceuticals usa inc. - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine injection is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations). in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1,500

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

meitheal pharmaceuticals inc - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine injection is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations). in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1500

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

amneal pharmaceuticals llc - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine injection is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, nelarabine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with nelarabine use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations) . in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1,500

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

novartis pharmaceuticals corporation - nelarabine (unii: 60158cv180) (nelarabine - unii:60158cv180) - nelarabine 5 mg in 1 ml - arranon is indicated for the treatment of t-cell acute lymphoblastic leukemia (t-all) and t-cell lymphoblastic lymphoma (t-lbl) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. none. risk summary based on its mechanism of action and findings in animal studies, arranon can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with arranon use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal, or fetal outcomes. there are risks to the pregnant woman associated with untreated leukemia or lymphoma (see clinical considerations) . in animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1500 mg/m2 /day (see data

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 30 mg - injection, modified release - excipient ingredients: polyglactin glucose; mannitol - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 20 mg - injection, modified release - excipient ingredients: mannitol; polyglactin glucose - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 10 mg - injection, modified release - excipient ingredients: mannitol; polyglactin glucose - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

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

novartis pharmaceuticals australia pty ltd - fluorometholone acetate, quantity: 1 mg/ml - eye drops, suspension - excipient ingredients: sodium chloride; tyloxapol; benzalkonium chloride; monobasic sodium phosphate; hyetellose; purified water; hydrochloric acid; sodium hydroxide; disodium edetate - indications as at 21 april 1989: flurometholone acetate ophalmic suspension is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.