Opdivo yakanyorwa muUnited States kurapwa kwegomarara remapapu. Varwere vazhinji vegomarara havakwanise kuenda kunze kwenyika kunorapwa nekuda kwezvikonzero zvakasiyana. Bvunza Opdivo kuti ingashandiswa sei uye tarisira kukwanisa kutenga mushonga kubva kunze kwenyika.
US FDA inowedzera mvumo yekushandisa Opdivo kurapa cancer yemapapu
Richard Pazdur, MD, Director of the Hematology and Oncology Products Division at the FDA ’s Center for Drug Evaluation and Research, said: “When the results of this clinical trial were first available in December 2014, FDA ’s active work with the company facilitated this early submission and review. , “” This approval will provide patients and health care providers with the knowledge that accompanies the survival benefits of Opdivo and will help guide patient care and future kenza yemapapu trials. “Priority review
Izvi zvakakosha hazvisanganisi ruzivo rwese rwunodiwa kuti ushandise OPDIVO zvakachengeteka uye zvinobudirira. Ndokumbira utarise kuOPDIVO kuti uwane ruzivo rwakakwana rwemishonga.
OPDIVO (nivolumab) jekiseni rekushandisa mutsinga
Mvumo yekutanga muUnited States: 2014
Zviratidzo uye kushandiswa
Shanduko huru dzichangoburwa (tsvuku ndiyo vhezheni itsva)
Zviratidzo uye kushandiswa (1.2) 3/2015
Yambiro uye chenjedzo (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 3/2015
Zviratidzo uye kushandiswa
OPDIVO munhu akarongedzerwa rufu receptor-1 (PD-1) yakakodzera kuvharidzira antibody therapy muvarwere vanotevera:
(1) Treatment of patients with unresectable metastatic melanoma and ipilimumab [ipilimumab] and, for example, BRAF V600 mutation-positive, disease progression after a BRAF inhibitor. (1.1) This indication is approved under accelerated approval based on the tumarara response rate and the durability of the response. Continued approval of this indication may depend on verification and the description of clinical benefit in the verification trial. (1.1, 14)
⑵ Use platinum-based chemotherapy or advanced metastatic squamous isina-diki kenza yemapapu kenza. (1.2)
Dosage uye nzira yekutonga
3 mg / kg yaipiwa ne intravenous infusion pamusoro pemaminitsi makumi matanhatu ega ega mavhiki maviri. (60)
Mafomu uye kutaurwa
Jekiseni: 40 mg / 4 mL uye 100 mg / 10 mL mhinduro mumidziyo inoraswa (3)
Contraindications
Yambiro uye matanho
Immune-mediated adverse reactions: Glucocorticoids inopihwa zvinoenderana nekuoma kwekuita. (5.1, 5.2, 5.3, 5.4, 5.6)
⑴ Pneumonia inodzivirira zvirwere: haina kupihwa zvine mwero uye yakagumiswa zvachose nekuda kwemabayo akanyanya kana anotyisidzira hupenyu. (5.1)
⑵ Immune-mediated colitis: Usape kugumiswa kwechigarire kune zvine mwero kana zvakanyanya uye zvinouraya colitis. (5.2)
(3) Immune-mediated hepatitis: kutarisa kuchinja mukushanda kwechiropa. Zvine mwero zvisiri zvekutonga uye kugumiswa zvachose kweakanyanya kana tyisidziro yehupenyu transaminase kana yakazara bilirubin kukwirira. (5.3)
⑷ Immune-mediated nephritis uye renal insufficiency: kutarisa kuchinja mukushanda kwetsvo. Kukundikana kuri pakati nepakati uye kugumiswa zvachose kwekukwira kwakanyanya kana kutyisidzira hupenyu mu serum creatinine. (5.4)
⑸ Immune-mediated hypothyroidism uye hyperthyroidism: tarisa shanduko muhutano hwethyroid. Tanga thyroid hormone replacement kana zvichidiwa. (5.5)
⑹ Fetal uye fetal toxicity: inogona kukonzera kukuvara kwe fetal. Ipa mazano pamusoro penjodzi dzinogona kuitika kune fetus uye kushandiswa kwekudzivirira kubata pamuviri kunobudirira. (5.7, 8.1, 8.3)
Kuchinja kwakashata
Kunyanya kuita kwakashata (≥20%) muvarwere vane melanoma ndeye rash. (6.1)
Maitiro akanyanya akajairika (≥20%) muvarwere vane squamous yakakura isiri-diki cell kenza yemapapu kuneta, kunetseka kufema, kurwadziwa kwetsandanyama, kurasikirwa nechido, kukosora, kusvotwa, uye kuvimbiswa.
Inoshandiswa muvanhu vakasiyana
⑴ Kuyamwisa: Rega kuyamwisa.
