Kurapwa Kutsva kweAdvanced Prostate Cancer muVakuru

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rakanyorwa Linda Hohnholz

Accord BioPharma, iyo US specialty division yeIntas Pharmaceuticals, Ltd yakatarisana nekuvandudzwa kweoncology, immunology, uye kurapwa kwakakomba, yakazivisa nhasi kuvhurwa kweUS kweCAMCEVI™ (leuprolide) 42mg jekiseni emulsion yekurapa cancer yeprostate yakakura muvakuru. Accord BioPharma iri kutungamira kugoverwa muUS Iyo US Food and Drug Administration yakabvumidza iyo New Drug Application (NDA) yeCAMCEVI kubva kuForesee Pharmaceuticals muna Chivabvu 25, 2021.

CAMCEVI ndiyo yekutanga-yakagadzirira-ku-baya jekiseni sterile kugadzirwa kwe leuprolide mesylate ye subcutaneous jekiseni rinouya mujekiseni risati razadzwa pasina kusanganisa kunodiwa. Mune yakavhurika-label, imwe-ruoko kudzidza kwevakuru ve137 vakagamuchira 42mg yeCAMCEVI paZuva 0 uye Vhiki 24, CAMCEVI yakapa testosterone kudzvinyirira kusingaite kucastrate mazinga mushure mejekiseni rekutanga, kubva Vhiki 4 kusvika Vhiki 48. CAMCEVI haifanirwe kushandiswa. mune varwere vane hypersensitivity kuGnRH kana GnRH analogs nekuda kwekugona kweanaphylactic reactions.1 Izvo zvinowanzoitika zvakashata (≥10%) zvinowanzoitika panguva yekutevera kwemazuva e336 kwaipisa kupisa, hypertension, jekiseni site reactions, kumusoro kwekufema kwepamusoro. kutapukira, kurwadziwa kwetsandanyama, kuneta, uye kurwadziwa kumagumo.

Varwere vanokodzera vanotemerwa CAMCEVI vachawana mukana wekubatsira masevhisi, akadai seyekutengesa copay rubatsiro mhinduro, zvirongwa zvevarwere, uye mukoti-vashandi vekiriniki hotline inopa-inoda mhinduro kumibvunzo kubva kuvarwere kana timu yavo yekuchengeta. Aya masevhisi erutsigiro evarwere akagadzirirwa zvakasarudzika kuti asangane nezvinodiwa zvevarwere vedu, achibatsira kubvisa zvipingamupinyi pakurapa uye kutsigira varwere mukati merwendo rwavo rwehutano neCAMCEVI. Kuti udzidze zvakawanda, shanya www.camcevihcp.com.

Pamusoro pezvo, Accord BioPharma inopa vashandi vehutano kuwana kuAccordConnects™, nharembozha yakagadzirirwa kubatsira maitiro ehutano kubata mune-yekuita hesita yeCAMCEVI. Iyo app inogonesa maitiro ehutano kuti atarise mabarcode kuti anyatso nyora CAMCEVI yemuviri wekuverenga kuverenga, purojekiti yeramangwana chigadzirwa inventory zvinodiwa, mhanyisa stock stock uye mashandisiro ekushandisa, uye inobvumira kumberi nekumashure kuteedzera kutsvaga chigadzirwa.

"Kutangwa kweCAMCEVI kweUS kunoratidza kuzvipira kwedu kuenderera mberi kweiyo biology yemishonga, kuona chirwere kubva pamaonero emurwere uye kugadzira marapirwo emhando yepamusoro anowedzera ruzivo rwekurapa," akadaro Chrys Kokino, Mutungamiriri weUS BioPharma kuAccord BioPharma.

Ruzivo Rwakakosha Chekuchengetedza: CAMCEVI, semamwe maGnRH agonists, inokonzera kuwedzera kwechinguvana mumazinga eserum e testosterone mukati mesvondo rekutanga rekurapwa izvo zvinogona kukonzera kuwedzera kwezviratidzo kwenguva pfupi. Varwere vane metastatic vertebral lesions uye / kana vane urinary tract obstruction inofanira kunyatsocherechedzwa mukati memavhiki mashomanana ekutanga ekurapa. Hyperglycemia uye njodzi yekuwedzera chirwere cheshuga yakashumwa mune varume vanogamuchira GnRH agonist. Ropa mazinga eglucose anofanirwa kutariswa uye kutariswa zvinoenderana neazvino kiriniki maitiro. Kuwedzera kwengozi yemyocardial infarction, kufa kamwe kamwe kwemoyo, uye sitiroko yakataurwa mukubatana nekushandiswa kweGnRH agonists. Varwere vanofanira kuongororwa nokuda kwechirwere chemwoyo uye maererano nezvino kliniki tsika. Androgen deprivation therapy inogona kuwedzera nguva yeQT. Kudzvinyirirwa kwakataurwa muvarwere vanogamuchira GnRH agonists, seCAMCEVI. Tarisa serum mazinga e testosterone anotevera jekiseni reCAMCEVI. Kubva pane zvakawanikwa muzvidzidzo zvemhuka uye nzira yekuita, CAMCEVI inogona kukonzera kukuvara kwe fetal kana ichipihwa kuvakadzi vane pamuviri. Izvo zvinowanzoitika (≥10%) maitiro asina kunaka panguva yekutevera kwepakati kwemazuva 336 kwaipisa kupisa, hypertension, jekiseni site reactions, repamusoro rekufema turakiti zvirwere, musculoskeletal kurwadziwa, kuneta, uye kurwadziwa mumigumo.

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Avatar of Linda Hohnholz

Linda Hohnholz

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