European Union - English - EMA (European Medicines Agency)

almirall, s.a. - lebrikizumab - dermatitis, atopic - other dermatological preparations - ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

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.

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

astrazeneca pharmaceuticals lp - benralizumab (unii: 71492ge1fx) (benralizumab - unii:71492ge1fx) - benralizumab 30 mg in 1 ml - fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see clinical studies (14)] . limitations of use: fasenra is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fasenra during pregnancy. healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/fasenra. risk summary the data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. in a prenatal and postnatal devel

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)

merck sharp & dohme (australia) pty ltd - pembrolizumab -

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - pembrolizumab - powder for solution for infusion - pembrolizumab 50 mg/vial - pembrolizumab - - melanoma:keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.- non-small cell lung cancer:• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc. • keytruda, as a single agent, is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda.• keytruda, as a single agent, is indic

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

genentech, inc. - emicizumab (unii: 7nl2e3f6k3) (emicizumab - unii:7nl2e3f6k3) - hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors. none. risk summary there are no available data on hemlibra use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with emicizumab-kxwh. it is not known whether hemlibra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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. risk summary there is no information regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production. human igg is known to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hemlibra and any potential adverse effects on the breastfed child from hemlibra or from the underlying maternal condition. contraception women of childbearing potential should use contraception while receiving hemlibra. the safety and efficacy of hemlibra have been established in pediatric patients. use of hemlibra in pediatric patients with hemophilia a is supported by two randomized trials (haven 1 and haven 3) and two single-arm trials (haven 2 and haven 4). all clinical trials included pediatric patients in the following age group: 47 adolescents (12 years up to less than 18 years). only haven 2 included pediatric patients in the following age groups: 55 children (2 years up to less than 12 years) and five infants (1 month up to less than 2 years). no differences in efficacy were observed between the different age groups [see clinical studies (14)] . the steady-state plasma trough concentrations of emicizumab-kxwh were comparable in adult and pediatric patients older than 6 months at equivalent weight-based doses. lower concentrations of emicizumab-kxwh were predicted in pediatric patients less than 6 months old [see clinical pharmacology (12.3)] . in general, the adverse reactions in hemlibra-treated pediatric patients were similar in type to those seen in adult patients with hemophilia a [see adverse reactions (6.1)] . clinical studies of hemlibra did not include a sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. be sure that you read, understand, and follow this instructions for use before injecting hemlibra. your healthcare provider should show you or your caregiver how to prepare, measure, and inject hemlibra properly before you use it for the first time. ask your healthcare provider if you have any questions. important information: - do not inject yourself or someone else unless you have been shown how to by your healthcare provider. - make sure the name hemlibra appears on the box and vial label. - before opening the vial, read the vial label to make sure you have the medicine strength(s) needed to give the dose prescribed by your healthcare provider. - your healthcare provider will determine your dose in milliliters (ml) that you will need to give based on your body weight. - hemlibra comes in multiple strengths. depending on your dose, you may need to use more than one vial to give your total prescribed dose. do not combine hemlibra vials of different concentrations in one injection to give the prescribed dose. - check the expiration date on the box and vial label. do not use if the expiration date has passed. - only use the vial one time. after you inject your dose, dispose of (throw away) any unused hemlibra left in the vial. do not save unused hemlibra in the vial for later use. - only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes. - only use the syringes, transfer needles and injection needles one time. dispose of (throw away) any used syringes and needles in a sharps disposal container. - if your prescribed dose is more than 2 ml, you will need to give more than one injection of hemlibra. storing hemlibra: - store hemlibra in the refrigerator at 36°f to 46°f (2°c to 8°c). do not freeze. - store hemlibra in the original carton to protect the vials from light. - do not shake hemlibra. - take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature before preparing an injection. - before giving the injection, unopened vials of hemlibra may be stored out of the refrigerator and then returned to the refrigerator. hemlibra should not be stored out of the refrigerator: for more than a total of 7 days or at a temperature greater than 86°f (30°c). - for more than a total of 7 days or - at a temperature greater than 86°f (30°c). keep hemlibra and all medicines out of the reach of children. inspecting the hemlibra vial and your supplies: - collect all supplies listed below to prepare and give your injection. - check the expiration date on the box, on the vial label, and on the supplies listed below. do not use if the expiration date has passed. - inspect the supplies for damage. do not use if they appear damaged or if they have been dropped. - place the supplies on a clean, well-lit flat work surface. hemlibra is colorless to slightly yellow in color. do not use the vial if: - the medicine is cloudy, hazy, or colored. - the medicine contains particles. - the cap covering the stopper is missing. - vial containing hemlibra - hemlibra instructions for use - alcohol wipes note: if you need to use more than one vial to inject your prescribed dose, you must use a new alcohol wipe for each vial. - gauze - cotton ball - syringe note: for injection amount up to 1 ml, use a 1 ml syringe. for injection amount between 1 ml and 2 ml, use a 2 ml or 3 ml syringe. - 18 gauge transfer needle with 5 micrometer filter. note: if you need to use more than one vial to inject your prescribed dose, you must use a new transfer needle for each vial. do not use the transfer needle to inject hemlibra. - injection needle with safety shield. you may use a 25, 26 or 27 gauge needle. do not use the injection needle to withdraw hemlibra from vial. - sharps disposal container - before use, allow the vial(s) to warm up to room temperature for about 15 minutes on a clean flat surface away from direct sunlight. - do not try to warm the vial by any other way. - wash your hands well with soap and water. - clean the chosen injection site area using an alcohol wipe. - let the skin dry for about 10 seconds. do not touch, fan, or blow on the cleaned area before your injection. - you can use your: thigh (front and middle). stomach area (abdomen), except for 2 inches around the navel (belly button). outer area of the upper arm (only if a caregiver is giving the injection). - thigh (front and middle). - stomach area (abdomen), except for 2 inches around the navel (belly button). - outer area of the upper arm (only if a caregiver is giving the injection). - you should use a different injection site each time you give an injection, at least 1 inch away from the area you used for your previous injection. - do not inject into areas that could be irritated by a belt or waistband. do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or the skin is broken. preparing the syringe for injection: - hemlibra must not be stored in the syringe . - hemlibra in the syringe must be injected under the skin (subcutaneous injection) immediately. - dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes in a sharps disposal container. important information after the injection: - do not rub the injection site after an injection. - if you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped. - if you have bruising (small area of bleeding under the skin), an ice pack can also be applied with gentle pressure to the site. if bleeding does not stop, please contact your healthcare provider. disposing of used hemlibra vial(s), needles, and syringes: - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not dispose of (throw away) any loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of heavy-duty plastic. can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out. upright and stable during use. leak-resistant. properly labeled to warn of hazardous waste inside the container. - made of heavy-duty plastic. - can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out. - upright and stable during use. - leak-resistant. - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of (throw away) any used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. important: always keep the sharps disposal container out of reach of children. 1. preparation - take the cap off the vial(s). - clean the top of the vial(s) stopper with an alcohol wipe. - dispose of (throw away) the vial cap(s) into the sharps disposal container. - push and twist the transfer needle with filter clockwise on to the syringe until it is fully attached. - slowly pull back on the plunger and draw air into the syringe that is the same amount for your prescribed dose. - hold the syringe by the barrel with the transfer needle pointing up. - carefully pull the transfer needle cap straight off and away from your body. do not throw the cap away. place the transfer needle cap down on a clean flat surface. you will need to recap the transfer needle after transferring the medicine. - do not touch the needle tip or place it on a surface after the needle cap has been removed. - keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the center of the vial stopper. - keep the needle in the vial and turn the vial upside down. - with the needle pointing upwards, push on the plunger to inject the air from the syringe above the medicine. - keep your finger pressed down on the syringe plunger. - do not inject air into the medicine as this could create air bubbles or foam in the medicine. - slide the tip of the needle down so that it is within the medicine. - slowly pull back the plunger to prevent air bubbles/foam. fill the syringe with more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. - keep the needle in the vial and check the syringe for larger air bubbles. too large an air bubble can reduce the dose you receive. - remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. move the tip of the needle above the medicine and slowly push the plunger up to push the air bubbles out of the syringe. - if the amount of hemlibra in the syringe is now at or below your prescribed dose, move the tip of the needle to within the medicine and slowly pull back the plunger until you have more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. - repeat the steps above until you have removed the larger air bubbles. do not use the transfer needle to inject hemlibra as this may cause harm such as pain and bleeding. 2. injection - remove the syringe and transfer needle from the vial. - using one hand, slide the transfer needle into the cap and scoop upwards to cover the needle. - once the needle is covered, push the transfer needle cap towards the syringe to fully attach it with one hand to prevent accidentally sticking yourself with the needle. - select and clean your injection site with an alcohol wipe. - let the skin dry for about 10 seconds. do not touch, fan, or blow on the cleaned area before your injection. - remove the transfer needle from the syringe by twisting counter-clockwise and gently pulling. - dispose of (throw away) the used transfer needle into a sharps disposal container. - push and twist the injection needle clockwise on to the syringe until it is fully attached. - move the safety shield away from the needle and towards the syringe barrel. - carefully pull the injection needle cap away from the syringe. - dispose of (throw away) the cap into a sharps disposal container. - do not touch the needle tip or allow it to touch any surface. - after the injection needle cap has been removed, hemlibra in the syringe must be injected right away. - slowly push the plunger to your prescribed dose. - ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose. - pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action. do not hold or push on the plunger while inserting the needle. - hold the position of the syringe and let go of the pinched injection site. - slowly inject all of hemlibra by gently pushing the plunger all the way down. - remove the needle and syringe from the injection site at the same angle as inserted. 3. disposal - move the safety shield forward 90°, away from the syringe barrel. - holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a "click". - if you do not hear a click, look to see that the needle is fully covered by the safety shield. - keep your fingers behind the safety shield and away from the needle at all times. - do not remove the injection needle from the syringe. - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. for further information, refer to the section "disposing of used hemlibra vial(s), needles, and syringes" above. - do not try to remove the used injection needle from the used syringe. - do not recap the injection needle with the cap. - important: always keep the sharps disposal container out of reach of children. - dispose of (throw away) any used vial(s), needles, vial and injection needle caps, and used syringes in a sharps disposal container. if you need to use more than one vial to get to your total prescribed dose, follow these steps after you have drawn up hemlibra from the first vial: - remove the syringe and transfer needle from the first vial. - using one hand , slide the transfer needle into the cap and scoop upwards to cover the needle. - once the needle is covered, push the transfer needle cap toward the syringe to fully attach it with one hand to prevent accidentally sticking yourself with the needle. - remove the transfer needle from the syringe by twisting counter- clockwise and gently pulling. - dispose of (throw away) the used transfer needle into a sharps disposal container. - push and twist a new transfer needle clockwise on to the syringe until it is fully attached. - slowly pull back the plunger and draw some air into the syringe. - hold the syringe by the barrel with the transfer needle cap pointing up. - carefully pull the transfer needle cap straight off and away from your body. do not throw the cap away. you will need to recap the transfer needle after drawing up the medicine. - do not touch the needle tip. - with the new vial on the flat working surface, insert the new transfer needle and syringe, straight down into the center of the vial stopper. - keep the transfer needle in the vial and turn the vial upside down. - with the needle pointing upwards, inject the air from the syringe above the medicine. - keep your finger pressed down on the syringe plunger. - do not inject air into the medicine as this could create air bubbles or foam in the medicine. - slide the tip of the needle down so that it is within the medicine. - slowly pull back the plunger to prevent air bubbles/foam. fill the syringe barrel with more than the amount of hemlibra needed for your prescribed dose. - be careful not to pull the plunger out of the syringe. do not use the transfer needle to inject hemlibra as this may cause harm such as pain and bleeding. for more information, go to www.hemlibra.com or call 1-866-hemlibra. hemlibra® [emicizumab-kxwh] manufactured by: genentech, inc . a member of the roche group 1 dna way south san francisco, ca 94080-4990 hemlibra® is a registered trademark of chugai pharmaceutical co., ltd., tokyo, japan ©2023 genentech, inc. all rights reserved. u.s. license no. 1048 this instructions for use has been approved by the u.s. food and drug administration. revised: 07/2023

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - emicizumab - solution for injection - emicizumab 150 mg / 1 ml - emicizumab - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - emicizumab - solution for injection - emicizumab 30 mg / 1 ml - emicizumab - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.