Israel - English - Ministry of Health

kamada ltd, israel - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - - bevacizumab kamada in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- bevacizumab kamada in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - bevacizumab kamada in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer.- bevacizumab kamada in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- bevacizumab kamada as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- bevacizumab kamada in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- bevacizumab kamada in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.- bevacizumab kamada in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents - bevacizumab kamada in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- bevacizumab kamada in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.

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

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

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 12 mg in 1.2 ml - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include relapsing-remitting disease and active secondary progressive disease, in adults. because of its safety profile, the use of lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms [see warnings and precautions (5)] . limitations of use lemtrada is not recommended for use in patients with clinically isolated syndrome (cis) because of its safety profile [see warnings and precautions (5)]. lemtrada is contraindicated in patients: - with known hypersensitivity or anaphylactic reactions to alemtuzumab or any of the excipients in lemtrada - who are infected with human immunodeficiency virus (hiv) because lemtrada causes prolonged reductions of cd4+ lymphocyte counts - with active infection risk summary there are no adequate data on the developmental risk associated with the use of lemtrada in pregnant women. lemtrada was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis [see animal data] . auto-antibodies may develop after administration of lemtrada. placental transfer of anti-thyroid antibodies resulting in neonatal graves' disease has been reported. 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. there is a pregnancy surveillance program for lemtrada. if lemtrada exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2. clinical considerations lemtrada induces persistent thyroid disorders [see warnings and precautions (5.8)] . untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. in mothers with graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal graves' disease. in a patient who developed graves' disease after treatment with alemtuzumab, placental transfer of anti-thyrotropin receptor antibodies resulted in neonatal graves' disease with thyroid storm in her infant who was born 1 year after alemtuzumab dosing [see warnings and precautions (5.1)] . data animal data when lemtrada was administered to pregnant hucd52 transgenic mice during organogenesis (gestation days [gd] 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, no teratogenic effects were observed. however, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during gd 11–15. in a separate study in pregnant hucd52 transgenic mice, administration of lemtrada during organogenesis (gd 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, decreases in b- and t-lymphocyte populations were observed in the offspring at both doses tested. in pregnant hucd52 transgenic mice administered lemtrada at doses of 3 or 10 mg/kg/day iv throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. decreases in t- and b-lymphocyte populations and in antibody response were observed in offspring at both doses tested. risk summary there are no data on the presence of alemtuzumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. alemtuzumab was detected in the milk of lactating hucd52 transgenic mice administered lemtrada [see animal data]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lemtrada and any potential adverse effects on the breastfed child from lemtrada or from the underlying maternal conditions. data animal data alemtuzumab was detected in the milk of lactating hucd52 transgenic mice following intravenous administration of lemtrada at a dose of 10 mg/kg on postpartum days 8–12. serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum day 13 and were associated with evidence of pharmacological activity (decrease in lymphocyte counts) in the offspring. contraception before initiation of lemtrada treatment, women of childbearing potential should be counselled on the potential for a serious risk to the fetus. to avoid in utero exposure to lemtrada, women of childbearing potential should use effective contraceptive measures when receiving a course of treatment with lemtrada and for 4 months following that course of treatment [see use in specific populations (8.1)] . infertility in hucd52 transgenic mice, administration of lemtrada prior to and during the mating period resulted in adverse effects on sperm parameters in males and reduced number of corpora lutea and implantations in females [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients less than 17 years of age have not been established. use of lemtrada is not recommended in pediatric patients due to the risks of autoimmunity, infusion reactions, and stroke, and because it may increase the risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma) [see warnings and precautions (5.1, 5.2, 5.3, 5.4)] . clinical studies of lemtrada did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.