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.

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

abbvie - daclizumab (unii: cuj2mvi71y) (daclizumab - unii:cuj2mvi71y) - daclizumab 150 mg in 1 ml - zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (ms). because of its safety profile, the use of zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms. zinbryta is contraindicated in patients with: - pre-existing hepatic disease or hepatic impairment, including alt or ast at least 2 times the uln, because zinbryta could exacerbate existing liver dysfunction [see dosage and administration (2.3) and warnings and precautions (5.1)] . - a history of autoimmune hepatitis or other autoimmune condition involving the liver [see warnings and precautions (5.1)]. - a history of hypersensitivity to daclizumab or any other components of the formulation. use in such patients may result in anaphylaxis or life-threatening multi-organ hypersensitivity [see warnings and precautions (5.4)] . risk summary there are no adequate data on the developmental risk associated with use of zinbryta in

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

alexion pharmaceuticals inc. - eculizumab (unii: a3ulp0f556) (eculizumab - unii:a3ulp0f556) - eculizumab 300 mg in 30 ml - soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (pnh) to reduce hemolysis. soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (ahus) to inhibit complement-mediated thrombotic microangiopathy. limitation of use soliris is not indicated for the treatment of patients with shiga toxin e. coli related hemolytic uremic syndrome (stec-hus). soliris is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. soliris is contraindicated for initiation in patients with unresolved serious neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary limited data on outcomes of pregnancies that have occurred following soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) in pregnancy (see clinical considerations ). animal studies using a mouse analogue of the soliris molecule (murine anti-c5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see data ). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. ahus in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (iugr), fetal death and low birth weight. data human data a pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to soliris have not suggested safety concerns. however, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. animal data animal reproduction studies were conducted in mice using doses of a murine anti-c5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human soliris dose, based on a body weight comparison. when animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. when maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. when maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). surviving offspring had normal development and reproductive function. risk summary although limited published data does not report detectable levels of eculizumab in human milk, maternal igg is known to be present in human milk. available information is insufficient to inform the effect of eculizumab on the breastfed infant. there are no data on the effects of eculizumab on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. safety and effectiveness of soliris for the treatment of pnh, gmg, or nmosd in pediatric patients have not been established. the safety and effectiveness of soliris for the treatment of ahus have been established in pediatric patients. use of soliris in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of soliris for the treatment of ahus. the studies included a total of 47 pediatric patients (ages 2 months to 17 years). the safety and effectiveness of soliris for the treatment of ahus appear similar in pediatric and adult patients [see adverse reactions (6.1), and clinical studies (14.2) ]. administer vaccinations for the prevention of infection due to neisseria meningitidis , streptococcus pneumoniae and haemophilus influenzae type b (hib) according to acip guidelines [see warnings and precautions (5.1, 5.3)] . fifty-one patients 65 years of age or older (15 with pnh, 4 with ahus, 26 with gmg, and 6 with nmosd) were treated with soliris in clinical trials in the approved indications. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

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

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

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

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 340 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - bevacizumab - - avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- avastin 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. - avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- avastin, 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).- avastin, 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.- avastin ( bevacizumab) in combination with paclitaxel, 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 - avastin ( bevacizumab) 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, 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. - bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - pertuzumab - concentrate for solution for infusion - pertuzumab 420 mg / 14 ml - pertuzumab - pertuzumab - early breast cancer perjeta is indicated for use in combination with trastuzumab and chemotherapy for: • the neoadjuvant treatment of patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. • the adjuvant treatment of patients with her2-positive early breast cancer (node positive) at high risk of recurrence .metastatic breast cancerperjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease.

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.