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

genentech, inc. - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - rituximab 120 mg in 1 ml - rituxan hycela is indicated for the treatment of adult patients with: - relapsed or refractory, follicular lymphoma as a single agent. - previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. rituxan hycela is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. rituxan hycela is indicated, in combination with fludarabine and cyclophosphamide (fc), for the treatment of adult patients with previously untreated and previously treated cll. - initiate treatment with rituxan hycela only after patients

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

genentech, inc. - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - rituximab 10 mg in 1 ml - rituxan is indicated for the treatment of adult patients with: - relapsed or refractory, low-grade or follicular, cd20-positive, b-cell nhl as a single agent. - previously untreated follicular, cd20-positive, b-cell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), low-grade, cd20-positive, b-cell nhl as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. - previously untreated diffuse large b-cell, cd20-positive nhl in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. rituxan is indicated for the treatment of pediatric patients aged 6 months and older with: - previously untreated, advanced stage, cd20-positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl), burkitt-like lymph

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

pfizer laboratories div pfizer inc - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - ruxience is indicated for the treatment of adult patients with: ruxience, in combination with fludarabine and cyclophosphamide (fc), is indicated for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. ruxience, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (tnf) antagonist therapies. ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis (mpa). none. risk summary based on human data, rituximab products can cause adverse developmental outcomes including b-cell lymphocytopenia in infants exposed in-utero (see clinical considerations) . in animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid b-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. advise pregnant women of the risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the estimated background risk in the u.s. general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions observe newborns and infants for signs of infection and manage accordingly. data human data postmarketing data indicate that b-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. rituximab was detected postnatally in the serum of infants exposed in-utero. animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). rituximab was administered as loading doses on post coitum (pc) days 20, 21, and 22, at 15, 37.5, or 75 mg/kg/day, and then weekly on pc days 29, 36, 43, and 50, at 20, 50, or 100 mg/kg/week. the 100 mg/kg/week dose resulted in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. rituximab crosses the monkey placenta. exposed offspring did not exhibit any teratogenic effects but did have decreased lymphoid tissue b cells. a subsequent pre- and postnatal reproductive toxicity study in cynomolgus monkeys was completed to assess developmental effects including the recovery of b cells and immune function in infants exposed to rituximab in-utero. animals were treated with a loading dose of 0, 15, or 75 mg/kg every day for 3 days, followed by weekly dosing with 0, 20, or 100 mg/kg dose. subsets of pregnant females were treated from pc day 20 through postpartum day 78, pc day 76 through pc day 134, and from pc day 132 through delivery and postpartum day 28. regardless of the timing of treatment, decreased b cells and immunosuppression were noted in the offspring of rituximab-treated pregnant animals. the b-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. there are limited data on the presence of rituximab in human milk, and the effect on the breastfed child, and there are no data on the effect on milk production. rituximab is detected in the milk of lactating cynomolgus monkeys, and maternal igg is present in human breast milk. rituximab has also been reported to be excreted at low concentrations in human breast milk. given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with ruxience and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children. rituximab products can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating ruxience. contraception females advise females of reproductive potential to use effective contraception during treatment with ruxience and for 12 months after the last dose. the safety and effectiveness of ruxience have not been established in pediatric patients with nhl, cll or ra. rituximab was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (pjia) due to concerns regarding the potential for prolonged immunosuppression as a result of b-cell depletion in the developing juvenile immune system. diffuse large b-cell nhl among patients with dlbcl evaluated in three randomized, active-controlled trials, 927 patients received rituximab in combination with chemotherapy. of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. no overall differences in effectiveness were observed between these patients and younger patients. cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. low-grade or follicular non-hodgkin's lymphoma patients with previously untreated follicular nhl evaluated in nhl study 5 were randomized to rituximab as single-agent maintenance therapy (n=505) or observation (n=513) after achieving a response to rituximab in combination with chemotherapy. of these, 123 (24%) patients in the rituximab arm were age 65 or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. other clinical studies of rituximab in low-grade or follicular, cd20-positive, b-cell nhl did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. chronic lymphocytic leukemia among patients with cll evaluated in two randomized active-controlled trials, 243 of 676 rituximab-treated patients (36%) were 65 years of age or older; of these, 100 rituximab-treated patients (15%) were 70 years of age or older. in exploratory analyses defined by age, there was no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 70 years of age or older in cll study 1 or in cll study 2; there was also no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 65 years of age or older in cll study 2 [see clinical studies (14.5)] . patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of rituximab. in cll study 1, the dose intensity of rituximab was similar in older and younger patients, however in cll study 2 older patients received a lower dose intensity of rituximab. the incidence of grade 3 and 4 adverse reactions was higher among patients receiving r-fc who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (cll study 1); 56% vs. 39% (cll study 2)], febrile neutropenia [16% vs. 6% (nhl study 10 (nct00719472))], anemia [5% vs. 2% (cll study 1); 21% vs. 10% (cll study 2)], thrombocytopenia [19% vs. 8% (cll study 2)], pancytopenia [7% vs. 2% (cll study 1); 7% vs. 2% (cll study 2)], and infections [30% vs. 14% (cll study 2)]. rheumatoid arthritis among the 2,578 patients in global ra studies completed to date, 12% were 65–75 years old and 2% were 75 years old and older. the incidences of adverse reactions were similar between older and younger patients. the rates of serious adverse reactions, including serious infections, malignancies, and cardiovascular events were higher in older patients. granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis of the 99 rituximab-treated gpa and mpa patients in gpa/mpa study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. no overall differences in efficacy were observed between patients that were 65 years old and over and younger patients. the overall incidence and rate of all serious adverse events was higher in patients 65 years old and over. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in gpa/mpa study 2, 30 (26%) of the enrolled patients were at least 65 years old, of which 12 patients were exposed to non-u.s.-licensed rituximab and 18 were exposed to azathioprine. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.

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

amgen inc - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - riabni is indicated for the treatment of adult patients with: - relapsed or refractory, low-grade or follicular, cd20-positive, b-cell nhl as a single agent. - previously untreated follicular, cd20-positive, b-cell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), low-grade, cd20-positive, b-cell nhl as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. - previously untreated diffuse large b-cell, cd20-positive nhl in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. riabni, in combination with fludarabine and cyclophosphamide (fc), is indicated for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. riabni, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more tnf antagonist therapies. riabni, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis (mpa). none. risk summary based on human data, rituximab products can cause adverse developmental outcomes including b-cell lymphocytopenia in infants exposed in utero (see clinical considerations ). in animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid b-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. advise pregnant women of the risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the estimated background risk in the u.s. general population of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions observe newborns and infants for signs of infection and manage accordingly. data human data postmarketing data indicate that b-cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to rituximab in utero . rituximab was detected postnatally in the serum of infants exposed in utero . animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). rituximab was administered as loading doses on post coitum (pc) days 20, 21 and 22, at 15, 37.5 or 75 mg/kg/day, and then weekly on pc days 29, 36, 43 and 50, at 20, 50 or 100 mg/kg/week. the 100 mg/kg/week dose resulted in 80% of the exposure (based on auc) of those achieved following a dose of 2 grams in humans. rituximab crosses the monkey placenta. exposed offspring did not exhibit any teratogenic effects but did have decreased lymphoid tissue b cells. a subsequent pre-and postnatal reproductive toxicity study in cynomolgus monkeys was completed to assess developmental effects including the recovery of b cells and immune function in infants exposed to rituximab in utero . animals were treated with a loading dose of 0, 15, or 75 mg/kg every day for 3 days, followed by weekly dosing with 0, 20, or 100 mg/kg dose. subsets of pregnant females were treated from pc day 20 through postpartum day 78, pc day 76 through pc day 134, and from pc day 132 through delivery and postpartum day 28. regardless of the timing of treatment, decreased b cells and immunosuppression were noted in the offspring of rituximab-treated pregnant animals. the b-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. there are limited data on the presence of rituximab in human milk and the effect on the breastfed child, and there are no data on the effect on milk production. rituximab is detected in the milk of lactating cynomolgus monkeys, and maternal igg is present in human breast milk. rituximab has also been reported to be excreted at low concentrations in human breast milk. given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with riabni and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children. rituximab products can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating riabni. contraception females advise females of reproductive potential to use effective contraception during treatment with riabni and for 12 months after the last dose. a pediatric assessment for riabni demonstrates that riabni is safe and effective for pediatric patients in an indication for which rituxan (rituximab) is approved. however, riabni is not approved for such indication due to marketing exclusivity for rituxan (rituximab). the safety and effectiveness of rituximab products, including riabni, have not been established in pediatric patients less than 2 years of age for gpa and mpa. the safety and effectiveness of rituximab products, including riabni, have not been established in pediatric patients with cll. rheumatoid arthritis the safety and effectiveness of rituximab products have not been established in pediatric patients with ra. rituximab was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (pjia) due to concerns regarding the potential for prolonged immunosuppression as a result of b-cell depletion in the developing juvenile immune system. diffuse large b-cell nhl among patients with dlbcl evaluated in three randomized, active-controlled trials, 927 patients received rituximab in combination with chemotherapy. of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. no overall differences in effectiveness were observed between these patients and younger patients. cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. low-grade or follicular non-hodgkin's lymphoma patients with previously untreated follicular nhl evaluated in nhl study 5 were randomized to rituximab as single-agent maintenance therapy (n = 505) or observation (n = 513) after achieving a response to rituximab in combination with chemotherapy. of these, 123 (24%) patients in the rituximab arm were age 65 or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. other clinical studies of rituximab in low-grade or follicular, cd20-positive, b-cell nhl did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. chronic lymphocytic leukemia among patients with cll evaluated in two randomized active-controlled trials, 243 of 676 rituximab-treated patients (36%) were 65 years of age or older; of these, 100 rituximab-treated patients (15%) were 70 years of age or older. in exploratory analyses defined by age, there was no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 70 years of age or older in cll study 1 or in cll study 2; there was also no observed benefit from the addition of rituximab to fludarabine and cyclophosphamide among patients 65 years of age or older in cll study 2 [see clinical studies (14.5)] . patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of rituximab. in cll study 1, the dose intensity of rituximab was similar in older and younger patients, however in cll study 2 older patients received a lower dose intensity of rituximab. the incidence of grade 3 and 4 adverse reactions was higher among patients receiving r-fc who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (cll study 1); 56% vs. 39% (cll study 2)], febrile neutropenia [16% vs. 6% (nhl study 10 (nct00719472)], anemia [5% vs. 2% (cll study 1); 21% vs. 10% (cll study 2)], thrombocytopenia [19% vs. 8% (cll study 2)], pancytopenia [7% vs. 2% (cll study 1); 7% vs. 2% (cll study 2)] and infections [30% vs. 14% (cll study 2)]. rheumatoid arthritis among the 2,578 patients in global ra studies completed to date, 12% were 65–75 years old and 2% were 75 years old and older. the incidences of adverse reactions were similar between older and younger patients. the rates of serious adverse reactions, including serious infections, malignancies, and cardiovascular events were higher in older patients. granulomatosis with polyangiitis (gpa) (wegener's granulomatosis) and microscopic polyangiitis of the 99 rituximab-treated gpa and mpa patients in gpa/mpa study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. no overall differences in efficacy were observed between patients that were 65 years old and over and younger patients. the overall incidence and rate of all serious adverse events was higher in patients 65 years old and over. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in gpa/mpa study 2, 30 (26%) of the enrolled patients were at least 65 years old, of which 12 patients were exposed to non-u.s.-licensed rituximab and 18 were exposed to azathioprine. the clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - truxima is indicated in adults for the following indications: * non-hodgkin’s lymphoma (nhl) truxima is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. truxima is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy. truxima is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.* chronic lymphocytic leukaemia (cll)truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.* granulomatosis with polyangiitis and microscopic polyangiitistruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg)) and microscopic polyangiitis (mpa).*pemphigus vulgaris (pv):truxima is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

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

cephalon, inc. - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - truxima (rituximab-abbs) is indicated for the treatment of adult patients with: - relapsed or refractory, low-grade or follicular, cd20-positive, b-cell nhl as a single agent. - previously untreated follicular, cd20-positive, b-cell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), low-grade, cd20-positive, b-cell nhl as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. - previously untreated diffuse large b-cell, cd20-positive nhl in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. truxima is indicated, in combination with fludarabine and cyclophosphamide (fc), for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. truxima, in combination w

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

pfizer pharmaceuticals inc. - rituximab (genetical recombination) [rituximab biosimilar 2] - injection

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

pfizer pharmaceuticals inc. - rituximab (genetical recombination) [rituximab biosimilar 2] - injection

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

kyowa kirin co.,ltd - rituximab (genetical recombination) [rituximab biosimilar 1] - injection

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

kyowa kirin co.,ltd - rituximab (genetical recombination) [rituximab biosimilar 1] - injection