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

e.r. squibb & sons, l.l.c. - elotuzumab (unii: 1351pe5ugs) (elotuzumab - unii:1351pe5ugs) - elotuzumab 300 mg - none. there are no available data on empliciti use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with elotuzumab. empliciti is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. lenalidomide and pomalidomide are only available through a rems program. the background risk of major birth defects and miscarriage for the indicated population 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 defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no data on the presence of empliciti in hum

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

eli lilly and company - ixekizumab (unii: bty153760o) (ixekizumab - unii:bty153760o) - ixekizumab 80 mg in 1 ml - taltz® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. taltz is indicated for the treatment of adult patients with active psoriatic arthritis. taltz is indicated for the treatment of adult patients with active ankylosing spondylitis. taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation. taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see warnings and precautions (5.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to taltz during pregnancy. pregnant women exposed to taltz are encouraged to enroll in the taltz pregnancy registry by calling 1-800-284-1695. contact information for the registry is also available on http://www.pregnancyregistry.lilly.com. risk summary available data from the published literature and the pharmacovigilance database with taltz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. human igg is known to cross the placental barrier; therefore, taltz may be transmitted from the mother to the developing fetus. an embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (mrhd) revealed no evidence of harm to the developing fetus. when dosing was continued until parturition, neonatal deaths were observed at 1.9 times the mrhd [see data] . the clinical significance of these nonclinical findings is unknown. the background risk of major birth defects and miscarriage for the indicated population 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 defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data an embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. no malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the mrhd (on a mg/kg basis of 50 mg/kg/week). ixekizumab crossed the placenta in monkeys. in a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the mrhd from the beginning of organogenesis to parturition. neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the mrhd (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the mrhd (on a mg/kg basis of 50 mg/kg/week). these neonatal deaths were attributed to early delivery, trauma, or congenital defect. the clinical significance of these findings is unknown. no ixekizumab-related effects on functional or immunological development were observed in the surviving infants from birth through 6 months of age. risk summary there are no available data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. ixekizumab was detected in the milk of lactating cynomolgus monkeys. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for taltz and any potential adverse effects on the breastfed infant from taltz or from the underlying maternal condition. the safety and effectiveness of taltz have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis. the safety and effectiveness of taltz in other pediatric indications and for pediatric subjects less than 6 years of age have not been established. of the 4204 adult psoriasis subjects exposed to taltz, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see clinical pharmacology (12.3)] .

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

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 30 mg in 1 ml - campath is indicated as a single agent for the treatment of b-cell chronic lymphocytic leukemia (b-cll). none. risk summary based on findings from animal studies, campath may cause fetal harm when administered to a pregnant woman. available data from published cohort studies in pregnant women are insufficient to establish a campath-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. alemtuzumab was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis (see data) . human igg antibodies are known to cross the placental barrier; therefore, campath may be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. infants born to pregnant women treated with campath may be at increased risk of infection (see clinical considerations) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other

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

biogen inc. - natalizumab (unii: 3jb47n2q2p) (natalizumab - unii:3jb47n2q2p) - natalizumab 300 mg in 15 ml - tysabri is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. tysabri increases the risk of pml [see warnings and precautions (5.1) ]. when initiating and continuing treatment with tysabri, physicians should consider whether the expected benefit of tysabri is sufficient to offset this risk. tysabri is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional cd therapies and inhibitors of tnf-α. tysabri should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of tnf-α [see warnings and precautions (5.1) ]. - tysabri is contraindicated in patients who have or have had progressive mult

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

genentech, inc. - bevacizumab (unii: 2s9zzm9q9v) (bevacizumab - unii:2s9zzm9q9v) - bevacizumab 100 mg in 4 ml - avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mcrc). avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mcrc who have progressed on a first-line bevacizumab product-containing regimen. limitations of use : avastin is not indicated for adjuvant treatment of colon cancer [see clinical studies (14.2)]. avastin, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (nsclc). avastin is indicated for the treatment of recurrent glioblastoma (gbm) in adults. avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mrcc). avastin, in combination with paclitaxel and cisplatin

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

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con

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

merck sharp & dohme llc - pembrolizumab (unii: dpt0o3t46p) (pembrolizumab - unii:dpt0o3t46p) - pembrolizumab 50 mg in 2 ml - keytruda® is indicated for the treatment of patients with unresectable or metastatic melanoma. keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous nsclc. keytruda, as a single agent, is indicated for the first-line treatment of patients with nsclc expressing pd-l1 [tumor proportion score (tps) ≥1%] as determined by an fda-approved test [see dosage and administration (2.1)] , with no egfr or alk genomic tumor aberrations, and is: - stage iii where patients are not candidates for surgical resection or definitive chemoradiation, or - metastatic. keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 (tps ≥1%) as determined by an fda-approved test [see dosage and administration (2.1)] , with disease progression on or after platinum-containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on fda-approved therapy for these aberrations prior to receiving keytruda. keytruda is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) nsclc in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. keytruda, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc. keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc). keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy. keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl). keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapy. keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy. limitations of use : keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy. keytruda, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. keytruda, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: - who are not eligible for any platinum-containing chemotherapy, or - who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. keytruda, as a single agent, 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 tumors who are ineligible for or have elected not to undergo cystectomy. keytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) solid tumors, as determined by an fda-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see dosage and administration (2.1)] . keytruda is indicated for the treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)] . this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies (14.9)] . continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic her2-negative gastric or gastroesophageal junction (gej) adenocarcinoma. keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (tumors with epicenter 1 to 5 centimeters above the gej) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: - in combination with platinum- and fluoropyrimidine-based chemotherapy, or - as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express pd-l1 (cps ≥10) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda, in combination with chemoradiotherapy (crt), is indicated for the treatment of patients with figo 2014 stage iii-iva cervical cancer. keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)]. keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda is indicated for the treatment of patients with hepatocellular carcinoma (hcc) secondary to hepatitis b who have received prior systemic therapy other than a pd-1/pd-l1-containing regimen. keytruda, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (btc). keytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc). keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc). keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc. keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see clinical studies (14.15)] . keytruda, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pmmr) as determined by an fda-approved test or not msi-h, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see dosage and administration (2.1)] . keytruda, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is msi-h or dmmr, as determined by an fda-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see dosage and administration (2.1)] . keytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by an fda-approved test [see dosage and administration (2.1)] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. this indication is approved under accelerated approval based on tumor response rate and durability of response [see clinical studies (14.17)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. limitations of use : the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established. keytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiation. keytruda 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 a single agent as adjuvant treatment after surgery. keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic tnbc whose tumors express pd-l1 (cps ≥10) as determined by an fda-approved test [see dosage and administration (2.1)] . keytruda is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for classical hodgkin lymphoma and primary mediastinal large b-cell lymphoma in adults [see indications and usage (1.4, 1.5), dosage and administration (2.2)] . this indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety [see clinical pharmacology (12.2), clinical studies (14.20)] . continued approval for this dosage may be contingent upon verification and description of clinical benefit in the confirmatory trials. none. risk summary based on its mechanism of action, keytruda can cause fetal harm when administered to a pregnant woman. there are no available human data informing the risk of embryo-fetal toxicity. in animal models, the pd-1/pd-l1 signaling pathway is important in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue (see data) . human igg4 (immunoglobulins) are known to cross the placenta; therefore, pembrolizumab has the potential to be transmitted from the mother to the developing fetus. advise pregnant women 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 2-4% and 15-20%, respectively. data animal data animal reproduction studies have not been conducted with keytruda to evaluate its effect on reproduction and fetal development. a literature-based assessment of the effects of the pd-1 pathway on reproduction demonstrated that a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. blockade of pd-l1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering keytruda during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 knockout mice. based on its mechanism of action, fetal exposure to pembrolizumab may increase the risk of developing immune-mediated disorders or of altering the normal immune response. risk summary there are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to keytruda are unknown. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with keytruda and for 4 months after the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating keytruda [see use in specific populations (8.1)]. contraception keytruda can cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.5), use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with keytruda and for 4 months after the last dose. the safety and effectiveness of keytruda as a single agent have been established in pediatric patients with melanoma, chl, pmbcl, mcc, msi-h or dmmr cancer, and tmb-h cancer. use of keytruda in pediatric patients for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1, 14.4, 14.5, 14.7, 14.14, 14.17)] . in keynote-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 to 17 years) with advanced melanoma, lymphoma, or pd-l1 positive solid tumors received keytruda 2 mg/kg every 3 weeks. the median duration of exposure was 2.1 months (range: 1 day to 25 months). adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults included pyrexia (33%), vomiting (29%), headache (25%), abdominal pain (23%), decreased lymphocyte count (13%), and decreased white blood cell count (11%). laboratory abnormalities that occurred at a ≥10% higher rate in pediatric patients when compared to adults were leukopenia (31%), neutropenia (28%), thrombocytopenia (22%), and grade 3 anemia (17%). the safety and effectiveness of keytruda in pediatric patients have not been established in the other approved indications [see indications and usage (1)] . of 3781 patients with melanoma, nsclc, hnscc, or urothelial carcinoma who were treated with keytruda in clinical studies, 48% were 65 years and over and 17% were 75 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 389 adult patients with chl who were treated with keytruda in clinical studies, 46 (12%) were 65 years and over. patients aged 65 years and over had a higher incidence of serious adverse reactions (50%) than patients aged younger than 65 years (24%). clinical studies of keytruda in chl did not include sufficient numbers of patients aged 65 years and over to determine whether effectiveness differs from that in younger patients. of 506 adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc following complete resection and platinum-based chemotherapy who were treated with keytruda in keynote-091, 242 (48%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 596 adult patients with tnbc who were treated with keytruda in combination with paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin in keynote-355, 137 (23%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of 406 adult patients with endometrial carcinoma who were treated with keytruda in combination with lenvatinib in keynote-775, 201 (50%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. of the 564 patients with locally advanced or metastatic urothelial cancer treated with keytruda in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. patients 75 years of age or older treated with keytruda in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. of the 432 patients randomized to keytruda in combination with axitinib in the keynote-426 trial, 40% were 65 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. of 292 adult patients with figo 2014 stage iii-iva cervical cancer who were treated with keytruda in combination with crt in keynote-a18, 42 (14%) were 65 years and over. no overall differences in safety or efficacy were observed between elderly and younger patients.

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

eli lilly australia pty ltd - ixekizumab, quantity: 80 mg/ml - injection, solution - excipient ingredients: water for injections; citric acid; sodium citrate dihydrate; polysorbate 80; sodium chloride - plaque psoriasis,taltz is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,taltz is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately, or who are intolerant, to previous dmard therapy.,taltz may be used as monotherapy or in combination with a conventional dmard (e.g. methotrexate).,axial spondyloarthritis - ankylosing spondylitis (radiographic axial spondyloarthritis),taltz is indicated for the treatment of active ankylosing spondylitis in adult patients.,axial spondyloarthritis - non-radiographic axial spondyloarthritis,taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri evidence, who have responded inadequately to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for infusion - trastuzumab 440 mg/ml - trastuzumab - trastuzumab - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :herceptin is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. herceptin should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay

Israel - English - Ministry of Health

medison pharma ltd - natalizumab - concentrate for solution for infusion - natalizumab 300 mg / 15 ml - natalizumab - natalizumab - tysabri is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis . to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. the safety and efficacy of tysabri beyond two years are unknown. because tysabri increases the risk of progressive multifocal leukoencephalopathy (pml), an opportunistic viral infection of the brain that usually leads to death or severe disability. tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies. safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.