万赛维的适应症是什么?
Developed by Roche, it is the first oral anti-cytomegalovirus infection drug for the treatment of retinitis. Valganciclovir hydrochloride is also approved for the prevention of cytomegalovirus infection after bone marrow, heart, liver, lung and other transplant surgeries. The general course of treatment is 3-6 months.
Vancevi was first launched in the United States in 2001 and has been approved in most countries around the world. It is imported into China under the trade name: Vancevi. The global sales of valganciclovir hydrochloride were US$521 million in 2009 and US$582 million in 2010, with the annual growth rate remaining above 12%. The cost of Vancevi’s API is less than $5,000 per kilogram, and the domestic wholesale price of each box of 60 tablets (approximately 30g) is $477, which shows that it is a product with good curative effects, a large market, and high added value.
Standard dosage: Vancevir is administered orally and should be taken with food. Valganciclovir hydrochloride tablets can be rapidly converted into ganciclovir in large amounts. The bioavailability of valganciclovir hydrochloride tablets as measured by ganciclovir is 10 times higher than that of ganciclovir capsules, so the dosage and usage instructions of valganciclovir hydrochloride tablets described below should be strictly followed. Induction therapy of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days. Prolonged induction therapy may increase the risk of bone marrow toxicity. Maintenance treatment of CMV retinitis: After induction therapy, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily. Induction therapy may be repeated in patients with worsening retinitis. Prophylaxis of CMV Infection in Transplant Patients: For patients who have received a solid organ transplant, the recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days after transplantation. Special Dosage Guidelines in Patients with Renal Impairment: Serum creatinine or creatinine clearance levels should be monitored closely. Dosage adjustments should be made based on creatinine clearance as shown below. For CrCl ≥ (greater than or equal to) 60 mL/min, the induction dose is 900 mg, twice a day; the maintenance dose is 900 mg, once a day. If the CrCl is 40-59 mL/min, the induction dose is 450 mg, twice a day; the maintenance dose is 450 mg, once a day. If the CrCl is 25-39 mL/min, the induction dose is 900 mg, once a day; the maintenance dose is 900 mg, once every other day. If the CrCl is 10-24 mL/min, the induction dose is 900 mg, once every other day; the maintenance dose is 900 mg, twice a week. The creatinine clearance rate can be estimated based on serum creatinine according to the following formula: Male = [140-age (years) x weight (kg) ÷ (72) x [0.011 x serum creatinine (umol/L)]. Female = 0.85 × male value. Patients undergoing hemodialysis: For patients undergoing hemodialysis (CrCl<10 mL/min), no recommended dosage can be given, so valganciclovir hydrochloride tablets cannot be used for such patients. Patients with severe leukopenia, neutropenia, anemia, thrombocytopenia and pancytopenia: Patients treated with valganciclovir hydrochloride tablets (or cyclovir) have cases of severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow suppression and aplastic anemia. Do not start tablet therapy if the absolute neutrophil count is less than 500/uL, the platelet count is less than 25,000/uL, or the hemoglobin is less than 8 g/dl.
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