European Union - English - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastic agents - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

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

beigene usa, inc. - tislelizumab (unii: 0kvo411b3n) (tislelizumab - unii:0kvo411b3n) - tevimbra (tislelizumab-jsgr), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a pd-(l)1 inhibitor. none. risk summary based on its mechanism of action, tevimbra can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tevimbra in pregnant women. animal studies have demonstrated that inhibition of the pd-1/pd-l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see data) . human igg4 immunoglobulins (igg4) are known to cross the placental barrier; therefore, tislelizumab-jsgr has the potential to be transmitted from the mother to the developing fetus. advise 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 animal reproduction studies have not been conducted with tevimbra to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering tevimbra during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to tislelizumab-jsgr may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there is no information regarding the presence of tislelizumab-jsgr in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose of tevimbra. tevimbra 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 tevimbra [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with tevimbra and for 4 months after the last dose of tevimbra. the safety and effectiveness of tevimbra have not been established in pediatric patients. of the 256 patients with escc who were treated with tevimbra in the clinical study rationale-302, 39% were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

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

genentech, inc. - ocrelizumab (unii: a10sjl62jy) (ocrelizumab - unii:a10sjl62jy) - ocrelizumab 300 mg in 10 ml - ocrevus is indicated for the treatment of: - relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults - primary progressive ms, in adults ocrevus is contraindicated in patients with: - active hbv infection [see dosage and administration (2.1) and warnings and precautions (5.2)] - a history of life-threatening infusion reaction to ocrevus [see warnings and precautions (5.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to ocrevus during pregnancy. physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com. risk summary ocrevus is a humanized monoclonal antibody of an immunoglobulin g1 subtype and immunoglobulins are known to cross the placental barrier. there are no adequate data on the developmental risk associated with use of ocrevus in pregnant women. however, transient peripheral b-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-cd20 antibodies during pregnancy. b-cell levels in infants following maternal exposure to ocrevus have not been studied in clinical trials. the potential duration of b-cell depletion in such infants, and the impact of b-cell depletion on vaccine safety and effectiveness, is unknown [see warnings and precautions (5.2)] . following administration of ocrelizumab to pregnant monkeys at doses similar to or greater than those used clinically, increased perinatal mortality, depletion of b-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data following intravenous administration of ocrevus to monkeys during organogenesis (loading doses of 15 or 75 mg/kg on gestation days 20, 21, and 22, followed by weekly doses of 20 or 100 mg/kg), depletion of b-lymphocytes in lymphoid tissue (spleen and lymph nodes) was observed in fetuses at both doses. intravenous administration of ocrevus (three daily loading doses of 15 or 75 mg/kg, followed by weekly doses of 20 or 100 mg/kg) to pregnant monkeys throughout the period of organogenesis and continuing through the neonatal period resulted in perinatal deaths (some associated with bacterial infections), renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe decreases in circulating b-lymphocytes in neonates. the cause of the neonatal deaths is uncertain; however, both affected neonates were found to have bacterial infections. reduced testicular weight was observed in neonates at the high dose. a no-effect dose for adverse developmental effects was not identified; the doses tested in monkey are 2 and 10 times the recommended human dose of 600 mg, on a mg/kg basis. risk summary there are no data on the presence of ocrelizumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. ocrelizumab was excreted in the milk of ocrelizumab-treated monkeys. human igg is excreted in human milk, and the potential for absorption of ocrelizumab to lead to b-cell depletion in the infant is unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ocrevus and any potential adverse effects on the breastfed infant from ocrevus or from the underlying maternal condition. contraception women of childbearing potential should use effective contraception while receiving ocrevus and for 6 months after the last infusion of ocrevus [see clinical pharmacology (12.3)] . safety and effectiveness of ocrevus in pediatric patients have not been established. clinical studies of ocrevus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

genentech, inc. - tocilizumab (unii: i031v2h011) (tocilizumab - unii:i031v2h011) - tocilizumab 20 mg in 1 ml - actemra® (tocilizumab) 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 disease-modifying anti-rheumatic drugs (dmards). actemra® (tocilizumab) is indicated for the treatment of giant cell arteritis (gca) in adult patients. actemra® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. actemra® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. actemra® (toci

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - tocilizumab - concentrate for solution for infusion - tocilizumab 20 mg/ml - tocilizumab - tocilizumab - actemra (tocilizumab), is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more dmards(disease modifying anti-rheumatic drugs) or tnf antagonists or in whom dmards cannot be used. actemra can be used alone or in combination with methotrexate or other dmards. actemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. actemra in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra in combination with methotrexate (mtx) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx.actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 3 years of age and older.actemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

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

roche products pty ltd - ocrelizumab, quantity: 300 mg - injection, concentrated - excipient ingredients: sodium acetate trihydrate; polysorbate 20; glacial acetic acid; water for injections; trehalose dihydrate - ocrevus is indicated for the treatment of patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and to reduce the frequency of relapse.,ocrevus is indicated for the treatment of patients with primary progressive multiple sclerosis (ppms) to delay the progression of physical disability

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards.,actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx.,in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,polyarticular juvenile idiopathic arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,subcutaneous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,actemra iv and sc can be given alone or in combination with methotrexate (mtx).

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

roche products pty ltd - tocilizumab, quantity: 200 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate dihydrate; water for injections; polysorbate 80; sucrose; dibasic sodium phosphate dodecahydrate - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate. polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

roche products pty ltd - tocilizumab, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; sucrose; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dodecahydrate; water for injections - rheumatoid arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations), intravenous formulation, actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

roche products pty ltd - tocilizumab, quantity: 400 mg - injection, concentrated - excipient ingredients: sucrose; polysorbate 80; monobasic sodium phosphate dihydrate; water for injections; dibasic sodium phosphate dodecahydrate - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate. polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations), intravenous formulation, actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.