Augusti 2021: Belzutifan (Welireg, Merck), hypoxia-inducibilis factor inhibitor, a Cibus et medicamentis administrationis adultorum aegrorum cum von Hippel-Lindau morbo, qui therationem requirunt pro consociata carcinomate cellularum renum (RCC), systematis nervosi centralis (CNS) hemangioblastomas vel pancreaticos tumores neuroendocrinos. (pNET) sed immediatam manum non require.
Belzutifan studebat in 61 aegris cum VHL-consociatis RCC (VHL-RCC) diagnosis innixa in VHL germline mutatione et saltem unus detectabilis tumor solidus renibus in permanenti Study 004 (NCT03401788) conclusus, inquisitio clinica aperta. Aegroti cum aliis VHL malignitatibus actis, ut CNS hemangioblastomas et pNET, conscribuntur. Belzutifan 120 medicamentum semel in die aegris datum est usque ad progressionem morborum vel toxicitatem intolerabilem.
Suprema responsionis rate (ORR) erat primarium punctum efficacitatis, quod per radiologicum aestimationem definitum est et per commissionem independentem recensionis utens RECIST v1.1. Duratio responsionis (DoR) et tempus responsionis erant duo proposita efficacia (TTR). In singulis cum VHL RCC associatis, ORR ipsius 49% (95 percent CI: 36, 62) inventa est. Omnes aegroti cum VHL-RCC qui responsionem habebant perscrutati sunt per menses saltem XVIII post curationem inceperunt. Medus DoR non occurrit; 18% conventi DoR minus quam 56 mensuum habebat et mediocris TTR octo mensium. 12 aegros cum hemangioblastoma mensurabili CNS ORR ex 8 centesimis habuit, et 24 aegros cum pNETO mensurabili habuit ORR de 63 percent in patientibus cum aliis malignitatibus VHL adiunctis non-RCC. Pro CNS hemangioblastomas et pNET, medianus DoR non convenerat, cum responsionibus durationibus minus quam 12 mensium in 83 centesimis et 12 centesimis aegris, respective.
Reduced haemoglobin, anaemia, fatigue, increased creatinine, headache, dizziness, elevated hyperglycemia, and nausea were the most prevalent adverse effects, including laboratory abnormalities, reported in almost 20% of patients who took belzutifan. Belzutifan usage can cause severe anaemia and hypoxia. Anemia was seen in 90% of participants in Study 004, with 7% having Grade 3 anaemia. Patients should be transfused as needed by their doctors. In individuals on belzutifan, the use of erythropoiesis stimulating drugs to treat anaemia is not suggested. Hypoxia occurred in 1.6 percent of patients in Study 004. Belzutifan can make some hormonal contraceptives ineffective, and it can harm an embryo or foetus if taken during pregnancy.
Belzutifan semel in die sumendus est, cum vel sine cibo, dosis 120 mg.
Reference: https://www.fda.gov/
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