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.

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

merck sharp & dohme (australia) pty ltd - pembrolizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - melanoma,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,keytruda? (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with stage iib, iic, or iii melanoma who have undergone complete resection.,non-small cell lung cancer (nsclc),,keytruda? (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumour aberrations.,keytruda? (pembrolizumab), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc.,keytruda? (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with nsclc expressing pd-l1 [tumour proportion score (tps) greater than or equal 1%] as determined by a validated test, with no egfr or alk genomic tumour aberrations, and is,,? stage iii where patients are not candidates for surgical resection or definitive chemoradiation, or,,? metastatic.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced nsclc whose tumours express pd-l1 with a greater than or equal 1% tps as determined by a validated test and who have received platinum-containing chemotherapy. patients with egfr or alk genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving keytruda.,keytruda? (pembrolizumab) is indicated as monotherapy for the adjuvant treatment of patients with stage ib (t2a greater than or equal 4 cm), ii, or iiia nsclc who have undergone complete resection and platinum-based chemotherapy.,head and neck squamous cell cancer (hnscc),,keytruda? (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-fu) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent hnscc, and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent hnscc with disease progression on or after platinum-containing chemotherapy and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,classical hodgkin lymphoma (chl),keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical hodgkin lymphoma (chl):,1. following autologous stem cell transplant (asct) or,,2. following at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option.,the approval of this indication in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (see section 5.1 pharmacodynamic properties, clinical trials).,primary mediastinal b-cell lymphoma (pmbcl),,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy. the approval of this indication is on the basis of objective response rate (orr) and duration of response from non-randomised studies. see section 5.1 pharmacodynamic properties, clinical trials.,urothelial carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.,endometrial carcinoma,,keytruda? (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,cervical cancer,keytruda? (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,renal cell carcinoma (rcc),keytruda? (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc).,keytruda? in combination with lenvima? (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,keytruda? (pembrolizumab), as monotherapy, is indicated for the adjuvant treatment of patients with rcc with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, clinical trials: renal cell carcinoma).,oesophageal cancer,keytruda? (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or her2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.,triple-negative breast cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (tnbc) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.,keytruda? (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic tnbc whose tumours express pd-l1 (cps greater than or equal 10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease. urothelial carcinoma,keytruda? (pembrolizumab) is indicated for the treatment of patients with bacillus calmette-guerin (bcg)-unresponsive, high-risk, non-muscle invasive bladder cancer (nmibc) with carcinoma in-situ (cis) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.,this indication was approved via the provisional approval pathway based on complete response rate and duration of response. continued approval of this indication depends on verification and description of benefit in confirmatory trials.,cutaneous squamous cell carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiation.,this indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. improvements in overall survival, progression-free survival, or healthrelated quality of life have not been established. full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.,tumour mutational burden-high (tmb-h) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (tmb-h) [greater than or equal 10 mutations/megabase (mut/mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.,this indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. the assumption that tmb-h status is predictive of the treatment effect of keytruda for every tissue type has not been verified. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are msi-h or dmmr, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.,microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) colorectal cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (crc) that is msi-h or dmmr as determined by a validated test.

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

novartis pharmaceuticals australia pty ltd - ranibizumab, quantity: 1.65 mg - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20; water for injections - lucentis (ranibizumab) is indicated in adults for:,- the treatment of neovascular (wet) age-related macular degeneration (amd),- the treatment of visual impairment due to diabetic macular oedema (dme),- the treatment of proliferative diabetic retinopathy (pdr),- the treatment of visual impairment due to choroidal neovascularisation.,- the treatment of visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm),- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (rvo)

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

roche products pty ltd - trastuzumab emtansine, quantity: 171 mg - injection, powder for - excipient ingredients: sodium hydroxide; sucrose; polysorbate 20; succinic acid - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.