오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol - bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: mannitol; water for injections - bortezomib accord, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib accord, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib accord is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: mannitol; water for injections - bortezomib accord, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib accord, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib accord is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - bortezomib, quantity: 2.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib juno in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib juno as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib juno is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib juno in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib baxter, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib baxter, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib baxter is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib baxter in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib-aft, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib-aft, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib-aft is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib-aft in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

미국 - 영어 - NLM (National Library of Medicine)

apotex corp - bortezomib (unii: 69g8bd63pp) (bortezomib - unii:69g8bd63pp) - bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma. bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. reactions have included anaphylactic reactions [see adverse reactions (6.1)]. bortezomib for injection is contraindicated for intrathecal administration. fatal events have occurred with intrathecal administration of bortezomib for injection. risk summary based on its mechanism of action [see clinical pharmacology (12.1) ] and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman. there are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (see data ). advise pregnant women of the potential risk to the fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. animal data bortezomib was not teratogenic in nonclinical developmental toxicity studies in rats and rabbits at the highest dose tested (0.075 mg/kg; 0.5 mg/m2 in the rat and 0.05 mg/kg; 0.6 mg/m2 in the rabbit) when administered during organogenesis. these dosages are approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area. bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area). pregnant rabbits given bortezomib during organogenesis at a dose of 0.05 mg/kg (0.6 mg/m2 ) experienced significant post-implantation loss and decreased number of live fetuses. live fetuses from these litters also showed significant decreases in fetal weight. risk summary there are no data on the presence of bortezomib or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. because many drugs are excreted in human milk and because the potential for serious adverse reactions in a breastfed child from bortezomib is unknown, advise nursing women not to breastfeed during treatment with bortezomib and for two months after treatment. based on its mechanism of action and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ]. pregnancy testing conduct pregnancy testing in females of reproductive potential prior to initiating bortezomib treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with bortezomib and for seven months after the last dose. males   males with female partners of reproductive potential should use effective contraception during treatment with bortezomib and for four months after the last dose.   infertility   based on the mechanism of action and findings in animals, bortezomib may have an effect on either male or female fertility [see nonclinical toxicology (13.1)] . safety and effectiveness have not been established in pediatric patients. the activity and safety of bortezomib in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies (pre-b cell all 77%, 16% with t-cell all, and 7% t-cell lymphoblastic lymphoma (ll)), all of whom relapsed within 36 months of initial diagnosis in a single-arm multicenter, nonrandomized cooperative group trial. an effective reinduction multiagent chemotherapy regimen was administered in three blocks. block 1 included vincristine, prednisone, doxorubicin and pegaspargase; block 2 included cyclophosphamide, etoposide and methotrexate; block 3 included high-dose cytosine arabinoside and asparaginase. bortezomib was administered at a dose of 1.3 mg/m2 as a bolus intravenous injection on days 1, 4, 8, and 11 of block 1 and days 1, 4, and 8 of block 2. there were 140 patients with all or ll enrolled and evaluated for safety. the median age was ten years (range: 1 to 26), 57% were male, 70% were white, 14% were black, 4% were asian, 2% were american indian/alaska native, 1% were pacific islander. the activity was evaluated in a prespecified subset of the first 60 evaluable patients enrolled on the study with pre-b all ≤21 years and relapsed <36 months from diagnosis. the complete remission (cr) rate at day 36 was compared to that in a historical control set of patients who had received the identical backbone therapy without bortezomib. there was no evidence that the addition of bortezomib had any impact on the cr rate. no new safety concerns were observed when bortezomib was added to a chemotherapy backbone regimen as compared with a historical control group in which the backbone regimen was given without bortezomib. the bsa-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults. of the 669 patients enrolled in the relapsed multiple myeloma study, 245 (37%) were 65 years of age or older: 125 (38%) on the bortezomib arm and 120 (36%) on the dexamethasone arm. median time to progression and median duration of response for patients ≥65 were longer on bortezomib compared to dexamethasone [5.5 mo vs 4.3 mo, and 8.0 mo vs 4.9 mo, respectively]. on the bortezomib arm, 40% (n=46) of evaluable patients aged ≥65 experienced response (cr + pr) vs 18% (n=21) on the dexamethasone arm. the incidence of grade 3 and 4 events was 64%, 78% and 75% for bortezomib patients ≤ 50, 51 to 64 and ≥65 years old, respectively [see adverse reactions (6.1), clinical studies (14.1)] . no overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving bortezomib; but greater sensitivity of some older individuals cannot be ruled out. no starting dosage adjustment of bortezomib is recommended for patients with renal impairment. in patients requiring dialysis, bortezomib should be administered after the dialysis procedure [see clinical pharmacology (12.3)] . no starting dosage adjustment of bortezomib is recommended for patients with mild hepatic impairment (total bilirubin ≤1x uln and ast >uln, or total bilirubin >1 to 1.5x uln and any ast). the exposure of bortezomib is increased in patients with moderate (total bilirubin ≥1.5 to 3x uln and any ast) and severe (total bilirubin >3x uln and any ast) hepatic impairment. reduce the starting dose in patients with moderate or severe hepatic impairment [see dosage and administration (2.8), clinical pharmacology (12.3)] . during clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

미국 - 영어 - NLM (National Library of Medicine)

sandoz inc - bortezomib (unii: 69g8bd63pp) (bortezomib - unii:69g8bd63pp) - bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma. bortezomib is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. reactions have included anaphylactic reactions [see adverse reactions (6.1)]. bortezomib is contraindicated for intrathecal administration. fatal events have occurred with intrathecal administration of bortezomib. risk summary based on its mechanism of action [see clinical pharmacology ( 12.1)] and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman. there are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (see data). advise pregnant women of the potential risk to the fetus. adverse outcomes in pregnancy occur regard

유럽 연합 - 영어 - EMA (European Medicines Agency)

pfizer europe ma eeig - bortezomib - multiple myeloma - other antineoplastic agents - bortezomib hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.