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

winthrop u.s, a business of sanofi-aventis u.s. llc - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman 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 pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (gd)1–5 (preimplantation), gd 6–10, or gd 11–16 (during organogenesis). oxaliplatin caused developmental mortality (increased early resorptions) when administered on days gd 6–10 and gd 11–16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days gd 6–10. risk summary there are no data on the presence of oxaliplatin or its metabolites in human or animal milk or its effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with oxaliplatin and for 3 months after the final dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating oxaliplatin [see use in specific populations (8.1)] . contraception oxaliplatin can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise female patients of reproductive potential to use effective contraception while receiving oxaliplatin and for 9 months after the final dose. males based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving oxaliplatin and for 6 months after the final dose [see nonclinical toxicology (13.1)] . infertility based on animal studies, oxaliplatin may impair fertility in males and females [see nonclinical toxicology (13.1)] . the safety and effectiveness of oxaliplatin in pediatrics have not been established. safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors. in a multicenter, open-label, non-comparative, non-randomized study (ard5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma. the dose limiting toxicity (dlt) was sensory neuropathy at a dose of 110 mg/m 2 . the main adverse reactions were: paresthesia (60%, grade 3–4: 7%), fever (40%, grade 3–4: 7%), and thrombocytopenia (40%, grade 3–4: 27%). no responses were observed. in an open-label non-randomized study (dfi7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma. the dlt was sensory neuropathy at a dose of 160 mg/m 2 . no responses were observed. in an open-label, single-agent study (ard5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal cns tumors. the most common adverse reactions reported were: leukopenia (67%, grade 3–4: 12%), anemia (65%, grade 3–4: 5%), thrombocytopenia (65%, grade 3–4: 26%), vomiting (65%, grade 3–4: 7%), neutropenia (58%, grade 3–4: 16%), and sensory neuropathy (40%, grade 3–4: 5%). in an open-label single-agent study (ard5530), oxaliplatin was administered to 123 pediatric patients with recurrent solid tumors, including neuroblastoma, osteosarcoma, ewing sarcoma or peripheral pnet, ependymoma, rhabdomyosarcoma, hepatoblastoma, high grade astrocytoma, brain stem glioma, low grade astrocytoma, malignant germ cell tumor and other tumors. the most common adverse reactions reported were: sensory neuropathy (52%, grade 3–4: 12%), thrombocytopenia (37%, grade 3–4: 17%), anemia (37%, grade 3–4: 9%), vomiting (26%, grade 3–4: 4%), increased alt (24%, grade 3–4: 6%), increased ast (24%, grade 3–4: 2%), and nausea (23%, grade 3–4: 3%). the pharmacokinetic parameters of ultrafiltrable platinum were evaluated in 105 pediatric patients during the first cycle. the mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was 4.7 l/h (%cv, 41%). mean platinum pharmacokinetic parameters in ultrafiltrate were c max of 0.75 ± 0.24 mcg/ml, auc 0–48h of 7.52 ± 5.07 mcg∙h/ml and auc inf of 8.83 ± 1.57 mcg∙h/ml at 85 mg/m 2 of oxaliplatin and c max of 1.10 ± 0.43 mcg/ml, auc 0–48h of 9.74 ± 2.52 mcg∙h/ml and auc inf of 17.3 ± 5.34 mcg∙h/ml at 130 mg/m 2 of oxaliplatin. in the adjuvant treatment trial [see clinical studies (14.1)] , 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. the effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive. patients greater than or equal to 65 years receiving oxaliplatin experienced more diarrhea and grade 3–4 neutropenia (45% vs 39%) compared to patients less than 65 years. in the previously untreated advanced colorectal cancer trial [see clinical studies (14.2)] , 99 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. the same efficacy improvements in response rate, time to tumor progression, and overall survival were observed in the greater than or equal to 65 years patients as in the overall study population. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope. in the previously treated advanced colorectal cancer trial [see clinical studies (14.3)] , 55 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. no overall differences in effectiveness were observed between these patients and younger adults. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, and fatigue. no significant effect of age on the clearance of ultrafiltrable platinum has been observed [see clinical pharmacology (12.3)] . the auc of unbound platinum in plasma ultrafiltrate was increased in patients with renal impairment [see clinical pharmacology (12.3)] . no dose reduction is recommended for patients with mild (creatinine clearance 50 to 79 ml/min) or moderate (creatinine clearance 30 to 49 ml/min) renal impairment, calculated by cockcroft-gault equation. reduce the dose of oxaliplatin in patients with severe renal impairment (creatinine clearance less than 30 ml/min) [see dosage and administration (2.3)].

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

winthrop u.s, a business of sanofi-aventis u.s. llc - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman 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 pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (gd)1–5 (preimplantation), gd 6–10, or gd 11–16 (during organogenesis). oxaliplatin caused developmental mortality (increased early resorptions) when administered on days gd 6–10 and gd 11–16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days gd 6–10. risk summary there are no data on the presence of oxaliplatin or its metabolites in human or animal milk or its effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with oxaliplatin and for 3 months after the final dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating oxaliplatin [see use in specific populations (8.1)] . contraception oxaliplatin can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise female patients of reproductive potential to use effective contraception while receiving oxaliplatin and for 9 months after the final dose. males based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving oxaliplatin and for 6 months after the final dose [see nonclinical toxicology (13.1)] . infertility based on animal studies, oxaliplatin may impair fertility in males and females [see nonclinical toxicology (13.1)] . the safety and effectiveness of oxaliplatin in pediatrics have not been established. safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors. in a multicenter, open-label, non-comparative, non-randomized study (ard5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma. the dose limiting toxicity (dlt) was sensory neuropathy at a dose of 110 mg/m 2 . the main adverse reactions were: paresthesia (60%, grade 3–4: 7%), fever (40%, grade 3–4: 7%), and thrombocytopenia (40%, grade 3–4: 27%). no responses were observed. in an open-label non-randomized study (dfi7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma. the dlt was sensory neuropathy at a dose of 160 mg/m 2 . no responses were observed. in an open-label, single-agent study (ard5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal cns tumors. the most common adverse reactions reported were: leukopenia (67%, grade 3–4: 12%), anemia (65%, grade 3–4: 5%), thrombocytopenia (65%, grade 3–4: 26%), vomiting (65%, grade 3–4: 7%), neutropenia (58%, grade 3–4: 16%), and sensory neuropathy (40%, grade 3–4: 5%). in an open-label single-agent study (ard5530), oxaliplatin was administered to 123 pediatric patients with recurrent solid tumors, including neuroblastoma, osteosarcoma, ewing sarcoma or peripheral pnet, ependymoma, rhabdomyosarcoma, hepatoblastoma, high grade astrocytoma, brain stem glioma, low grade astrocytoma, malignant germ cell tumor and other tumors. the most common adverse reactions reported were: sensory neuropathy (52%, grade 3–4: 12%), thrombocytopenia (37%, grade 3–4: 17%), anemia (37%, grade 3–4: 9%), vomiting (26%, grade 3–4: 4%), increased alt (24%, grade 3–4: 6%), increased ast (24%, grade 3–4: 2%), and nausea (23%, grade 3–4: 3%). the pharmacokinetic parameters of ultrafiltrable platinum were evaluated in 105 pediatric patients during the first cycle. the mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was 4.7 l/h (%cv, 41%). mean platinum pharmacokinetic parameters in ultrafiltrate were c max of 0.75 ± 0.24 mcg/ml, auc 0–48h of 7.52 ± 5.07 mcg∙h/ml and auc inf of 8.83 ± 1.57 mcg∙h/ml at 85 mg/m 2 of oxaliplatin and c max of 1.10 ± 0.43 mcg/ml, auc 0–48h of 9.74 ± 2.52 mcg∙h/ml and auc inf of 17.3 ± 5.34 mcg∙h/ml at 130 mg/m 2 of oxaliplatin. in the adjuvant treatment trial [see clinical studies (14.1)] , 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. the effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive. patients greater than or equal to 65 years receiving oxaliplatin experienced more diarrhea and grade 3–4 neutropenia (45% vs 39%) compared to patients less than 65 years. in the previously untreated advanced colorectal cancer trial [see clinical studies (14.2)] , 99 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. the same efficacy improvements in response rate, time to tumor progression, and overall survival were observed in the greater than or equal to 65 years patients as in the overall study population. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope. in the previously treated advanced colorectal cancer trial [see clinical studies (14.3)] , 55 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. no overall differences in effectiveness were observed between these patients and younger adults. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, and fatigue. no significant effect of age on the clearance of ultrafiltrable platinum has been observed [see clinical pharmacology (12.3)] . the auc of unbound platinum in plasma ultrafiltrate was increased in patients with renal impairment [see clinical pharmacology (12.3)] . no dose reduction is recommended for patients with mild (creatinine clearance 50 to 79 ml/min) or moderate (creatinine clearance 30 to 49 ml/min) renal impairment, calculated by cockcroft-gault equation. reduce the dose of oxaliplatin in patients with severe renal impairment (creatinine clearance less than 30 ml/min) [see dosage and administration (2.3)].

Israel - English - Ministry of Health

abic marketing ltd, israel - oxaliplatin - concentrate for solution for infusion - oxaliplatin 5 mg/ml - oxaliplatin - oxaliplatin - oxaliplatin in combination with 5- fluorouracil (5-fu) and folinic acid (fa) is indicated for : - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour. - treatment of metastatic colorectal cancer.oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on nccnguidelines, version 2.2014).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - oxaliplatin - powder for solution for infusion - oxaliplatin 50 mg/vial - oxaliplatin - oxaliplatin - oxaliplatin in combination with 5-fluorouracil (5-fu) and folinic acid (fa) is indicated for: • adjuvant treatment of stage iii (duke‘s c) colon cancer after complete resection of primary tumor. • treatment of metastatic colorectal cancer. oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on nccn guidelines, version 2.2014).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - oxaliplatin - powder for solution for infusion - oxaliplatin 100 mg/vial - oxaliplatin - oxaliplatin - oxaliplatin in combination with 5-fluorouracil (5-fu) and folinic acid (fa) is indicated for: • adjuvant treatment of stage iii (duke‘s c) colon cancer after complete resection of primary tumor. • treatment of metastatic colorectal cancer. oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on nccn guidelines, version 2.2014).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - oxaliplatin - powder for solution for infusion - oxaliplatin 150 mg/vial - oxaliplatin - oxaliplatin - oxaliplatin in combination with 5-fluorouracil (5-fu) and folinic acid (fa) is indicated for: • adjuvant treatment of stage iii (duke‘s c) colon cancer after complete resection of primary tumor. • treatment of metastatic colorectal cancer. oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on nccn guidelines, version 2.2014).

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - oxaliplatin - concentrate for soln for inf - 5 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - oxaliplatin - pdr for soln for infusion - 5 mg/ml

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

wockhardt bio pty ltd - oxaliplatin, quantity: 100 mg - injection, concentrated - excipient ingredients: water for injections; nitrogen - oxaliplatin is indicated for adjuvant treatment of stage iii (duke?s c) colon cancer, in combination with fluoropyrimidine agent.,oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer.,oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer,oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for the treatment of patients with advanced oesophagogastric cancer.

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

wockhardt bio pty ltd - oxaliplatin, quantity: 50 mg - injection, concentrated - excipient ingredients: nitrogen; water for injections - oxaliplatin is indicated for adjuvant treatment of stage iii (duke?s c) colon cancer, in combination with fluoropyrimidine agent.,oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer.,oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer,oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for the treatment of patients with advanced oesophagogastric cancer.