Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

kyowa kirin co.,ltd - l-asparaginase - injection

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sanofi-aventis - asparaginase - solution - 10000 iu

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

servier malaysia sdn bhd - pegaspargase -

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

porton biopharma ltd - crisantaspase - powder for solution for injection - 10000unit

New Zealand - English - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - pegaspargase 3750 u (4050u including overage) - powder for injection - 3750 u/5ml - active: pegaspargase 3750 u (4050u including overage) excipient: dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate sodium chloride sodium hydroxide sucrose - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - injection, solution - 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with all. oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with all and hypersensitivity to native forms of l-asparaginase. - history of serious allergic reactions to oncaspar® - history of serious thrombosis with prior l-asparaginase therapy - history of pancreatitis with prior l‑asparaginase therapy - history of serious hemorrhagic events with prior l-asparaginase therapy pregnancy category c . animal reproduction studies have not been conducted with oncaspar® . it is also not known whether oncaspar® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. oncaspar® should be given to a pregnant woman only if clearly needed. it is not known whether oncaspar® is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reacti

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

baxalta us inc. - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - pegaspargase 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary there are no available data on the use of oncaspar i

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

servier pharmaceuticals llc - calaspargase pegol (unii: t9fvh03hmz) (calaspargase pegol - unii:t9fvh03hmz) - asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. asparlas is contraindicated in patients with: - history of serious hypersensitivity reactions, including anaphylaxis, to pegylated l-asparaginase therapy [see warnings and precautions (5.1)] - history of serious pancreatitis during previous l-asparaginase therapy [see warnings and precautions (5.2)] - history of serious thrombosis during previous l-asparaginase therapy [see warnings and precautions (5.3)] - history of serious hemorrhagic events during previous l-asparaginase therapy [see warnings and precautions (5.4)] - severe hepatic impairment [see warnings and precautions (5.5)] risk summary based on published literature studies with l-asparaginase in pregnant animals, asparlas can cause fetal harm when administered to a pregnant woman. there are no available data on asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (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 are 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 u/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on auc) to pregnant rats during the period of organogenesis. maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. no evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. published literature studies in which pregnant rabbits were administered l-asparaginase suggested harm to the animal offspring. risk summary there are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with asparlas and for 3 months after the last dose. asparlas can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended in females of reproductive potential prior to initiating asparlas. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with asparlas and for at least 3 months after the last dose. the safety and effectiveness of asparlas in the treatment of all have been established in pediatric patients 1 month to <17 years (no data for the age group <1 month old). use of asparlas in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety from a second trial. the trials included 208 children with all or lymphoblastic lymphoma treated with asparlas; there were 19 infants (1 month to <2 years old), 128 children (2 years to <12 years old), and 61 adolescents (12 years to <17 years old). there were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups [see adverse reactions (6.1), clinical studies (14)] .

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).