Agusta 2021: Belzutifan (Welireg, Merck), mai hana hypoxia-inducible factor inhibitor, Hukumar Abinci da Magunguna ta amince da shi ga tsofaffi marasa lafiya tare da cutar von Hippel-Lindau waɗanda ke buƙatar magani don haɗarin ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar cuta (RCC), tsarin juyayi na tsakiya (CNS) hemangioblastomas, ko ciwace-ciwacen neuroendocrine. (pNET) amma basa buƙatar tiyata nan take.
Anyi nazarin Belzutifan a cikin marasa lafiya 61 tare da RCC (VHL-RCC) mai alaƙa da VHL dangane da canjin ƙwayar cuta ta VHL kuma aƙalla ƙwayar cuta mai ƙarfi guda ɗaya da aka iya ganowa a cikin koda a cikin Nazarin 004 mai gudana (NCT03401788), binciken asibiti mai buɗe ido. Marasa lafiya tare da wasu cututtukan da ke da alaƙa da VHL, kamar CNS hemangioblastomas da pNET, an yi rajista. An ba Belzutifan 120 MG ga marasa lafiya sau ɗaya a rana har sai cutar ta ci gaba ko cutar da ba za a iya jurewa ba.
Gabaɗaya ƙimar amsawa (ORR) ita ce ƙarshen mahimmancin inganci, kamar yadda aka tantance ta kimiyar rediyo kuma kwamitin bita mai zaman kanta ya tantance ta amfani da RECIST v1.1. Tsawon lokacin amsawa (DoR) da lokacin amsawa wasu manufofi biyu ne na inganci (TTR). A cikin mutane tare da RCC mai alaƙa da VHL, an sami ORR na 49% (95 bisa dari CI: 36, 62). Duk marasa lafiya tare da VHL-RCC waɗanda ke da amsa an bi su aƙalla watanni 18 bayan fara magani. Ba a sadu da DoR na tsakiya ba; 56% na masu amsa suna da DoR na ƙasa da watanni 12 da matsakaicin TTR na watanni 8. Marasa lafiya 24 tare da CNS hemangioblastomas masu aunawa suna da ORR na kashi 63, kuma marasa lafiya 12 tare da pNET mai aunawa suna da ORR na kashi 83 cikin marasa lafiya tare da sauran cututtukan da ba na RCC ba. Ga CNS hemangioblastomas da pNET, ba a sadu da DoR na tsakiya ba, tare da tsawon amsawar da bai wuce watanni 12 a kashi 73 da kashi 50 na marasa lafiya ba, bi da bi.
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.
Ya kamata a ɗauki Belzutifan sau ɗaya a rana, tare da ko ba tare da abinci ba, a cikin sashi na 120 MG.
reference: https://www.fda.gov/
Duba cikakkun bayanai nan.
