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

dr. reddy's laboratories, 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

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

shorla oncology 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 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

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

aqvida gmbh - 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 tera- togenicity 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 estimat- ed 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 adminis- tered 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 recom- mended 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 de- layed 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 injec- tion, 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 wom- an [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 assessed 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 refrac- tory 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 che- motherapy 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 nelar- abine 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 re- actions. 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.

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

leo pharma pty ltd - calcipotriol, quantity: 20.5 microgram/g; betamethasone dipropionate, quantity: 264 microgram/g (equivalent: betamethasone, qty 205 microgram/g) - foam - excipient ingredients: polyoxypropylene-11 stearyl ether; liquid paraffin; dl-alpha-tocopherol; white soft paraffin; butane; methyl ether - enstilar is indicated for the topical treatment of psoriasis vulgaris in adults.

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

novartis pharmaceuticals australia pty ltd - canakinumab -

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - canakinumab 150mg - powder for injection - 150 mg - active: canakinumab 150mg excipient: histidine histidine hydrochloride polysorbate 80 sucrose - ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps), in adults and children aged 2 years and older including: · familial cold autoinflammatory syndrome (fcas) /familial cold urticaria (fcu) · muckle-wells syndrome (mws) · neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca).

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

genzyme corporation - laronidase (unii: wp58svm6r4) (laronidase - unii:wp58svm6r4) - laronidase 2.9 mg in 5 ml - aldurazyme® is indicated for the treatment of: - adult and pediatric patients with hurler and hurler-scheie forms of mucopolysaccharidosis i (mps i) and - patients with the scheie form of mps i who have moderate to severe symptoms. limitations of use - the safety and effectiveness of treating mildly affected patients with the scheie form have not been established. - the effect of aldurazyme on central nervous system manifestations of the disorder has not been determined. none. pregnancy exposure registry an mps i registry has been established. pregnant women with mps i and healthcare providers are encouraged to contact the pregnancy sub-registry by visiting www.registrynxt.com or calling 1-800-745-4447 ext. 15500. risk summary available data from the mps i registry pregnancy sub-registry, published case reports, and the global pharmacovigilance database with aldurazyme use in more than 30 pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for mps i during pregnancy should be individualized to the pregnant woman. untreated mps i may result in adverse pregnancy and infant outcomes (see clinical considerations ). no evidence of fetal harm has been observed in rats when laronidase was administered during organogenesis at doses up to 6.2 times the recommended human dose (see data). the 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 is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk pregnancy can exacerbate preexisting clinical manifestations of mps and lead to adverse pregnancy outcomes for both mother and fetus. data animal data when laronidase was administered to pregnant female rats during organogenesis (gestation days [gd] 7-17) at doses of 0, 0.036, 0.36 or 3.6 mg/kg/day intravenously (equivalent to 7.3, 73.1, 730.8 units/kg/day) decreased maternal body weight gains and food consumption were observed with no corresponding effects on reproductive and litter parameters including number and distribution of corpora lutea, implantations and early and late resorptions at doses up to 3.6 mg/kg/day (6.2 times the recommended human dose of 0.58 mg/kg on a mg/kg basis). laronidase has not been evaluated for effects on embryo-fetal development in any other species. risk summary available information from one mother:infant pair are insufficient to evaluate the presence or absence of laronidase in human milk. no adverse effects have been reported in breastfed infants in postmarketing cases of aldurazyme use in lactating women. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aldurazyme and any potential adverse effects on the breastfed child from aldurazyme or from the underlying maternal condition. lactating women with mps i and healthcare providers are encouraged to contact the mps i registry by visiting www.registrynxt.com or calling 1-800-745-4447 ext. 15500. the safety and effectiveness of aldurazyme have been established for the treatment of pediatric patients with hurler and hurler-scheie forms of mucopolysaccharidosis i (mps i) and the treatment of pediatric patients with the scheie form of mps i who have moderate to severe symptoms. the safety and effectiveness aldurazyme for the treatment of mildly affected pediatric patients with the scheie form have not been established. use of aldurazyme for these indications is supported by evidence from an adequate and well-controlled clinical study (study1) with an open label extension (study 2) in adult and pediatric patients with mps i, and from an open label, uncontrolled clinical study in pediatric patients with mps i, 6 months to 5 years of age (study 3). the safety and effectiveness of aldurazyme in pediatric patients 6 months of age to 5 years of age was found to be similar to pediatric patients 6 to 18 years of age and adults for these indications [see adverse reactions (6.1), clinical studies (14)]. clinical studies of aldurazyme did not include patients 65 years of age and older to determine if they respond differently from younger patients.

Israel - English - Ministry of Health

novartis israel ltd - canakinumab - powder for solution for injection - canakinumab 150 mg / 1 ml - canakinumab - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is i

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - canakinumab - powder for solution for injection - 150mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - canakinumab - solution for injection - 150mg/1ml