万赛维详细说明书

Detailed instructions

Generic name: Valganciclovir (valganciclovir hydrochloride tablets)

Product name: valcyte

Full names: Valcyte, Valganciclovir hydrochloride tablets, valcyte, Valganciclovir, valgansiklovir

Indications:

Valganciclovirhydrochloride, chemically named (S)-2-amino-3-methylbutyric acid 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester hydrochloride, is an oral anti-cytomegalovirus (CMV) infection drug developed by the Swiss company Roche. It was approved by the US FDA in May 2001. It is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome (AIDS). In May 2003, its indications were expanded to prevent and treat secondary CMV infection in organ transplant recipients. This product is a prodrug of ganciclovir. After oral administration, it is rapidly hydrolyzed into ganciclovir by esterase in intestinal and liver cells, thereby exerting its medicinal effect. Its oral absorption bioavailability is 60%, which is 10 times that of 2, and its toxicity is greatly reduced.

Common dosage:

CMV retinitis: induction period, 900mg, po, q12h, treatment course is 3 weeks. Maintenance period, 900 mg, po, qd, until immune reconstitution (CD4>150/μL for 3 to 6 consecutive months, eye examination confirms stable lesions).

Gastrointestinal CMV disease: 900mg, po, q12h, treatment course is 3 to 6 weeks (maintenance treatment is considered when the condition is severe or relapses).

Prophylaxis for CMV infection in patients at high risk for kidney, heart, and combined kidney-pancreas transplantation: 900 mg po, qd, starting within 10 days of transplantation and continuing until 100 days after transplantation.

Taboo:

It is contraindicated in those who have allergic reactions to valganciclovir, ganciclovir or any other ingredients in the medicine. It is contraindicated in patients with severe agranulocytosis (ANC<500/μL), thrombocytopenia (<25000/μL), anemia (hemoglobin<80g/L) and renal failure.

Adverse reactions and precautions:

In a randomized, open-label clinical trial, 158 patients were randomized to receive oral valganciclovir 900 mg or intravenous ganciclovir 5 mg·kg-1, bid, then changed to qd after 3 weeks, and then treated for 1 week. Tolerability of induction therapy with oral valganciclovir and intravenous ganciclovir was similar. The main adverse reactions include diarrhea (16% vs 10%), neutropenia (11% vs 13%), nausea (8% vs 14%), headache (9% vs 5%), and anemia (8% vs 8%). When 370 patients took daily oral valganciclovir maintenance therapy (68% of patients were treated for more than 9 months, and the longest was 36 months), the adverse reactions that occurred included diarrhea, fever, nausea, neutropenia, anemia, headache, vomiting, insomnia, abdominal pain, thrombocytopenia, and retinal detachment. Increased serum creatinine (>15 mg·L-1) occurred in 15% of patients. This product is contraindicated in those allergic to ganciclovir or valganciclovir. This product is contraindicated in patients with neutrophil count <500, blood count <25,000, hemoglobin concentration <80g·L-1, and hemodialysis patients. Patients with renal insufficiency should use it with caution and adjust the dose appropriately.