盐酸缬更昔洛韦片中文说明书

Chinese instruction manual

Generic name: Valganciclovir hydrochloride tablets

English name: Valganciclovir Hydrochloride Tablets

Chinese Pinyin: Yansuan Jiegengxiluowei Pian

Indications: In May 2001, the US FDA approved the market. Valcyte hydrochloride tablets are clinically used to treat acute retinitis caused by CMV infection in patients with acquired immune deficiency syndrome. In May 2003, its indications were expanded. Valcyte hydrochloride tablets are used to prevent and treat secondary CMV infection in organ transplant recipients. On August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

Usage and dosage:

Standard dosage: Valganciclovir hydrochloride tablets are administered orally and should be taken with food. Valganciclovir hydrochloride tablets can be rapidly converted into ganciclovir in large quantities. 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.

Side effects:

Common reversible granulocytopenia (good response to G-CSF), thrombocytopenia, diarrhea, and nausea. Anemia, fever, rash, headache, and dizziness are occasionally seen. Hepatotoxicity and convulsions are rare.

Note:

Valganciclovir hydrochloride is the prodrug of ganciclovir. It is rapidly converted into ganciclovir after oral administration and needs to be taken with food. Blood images need to be monitored during medication; discontinue the medication or add G-CSF if the peripheral blood neutrophil count is <500/μL; consider discontinuing the medication if the peripheral blood platelet count is <25 000/μL or hemoglobin <80g/L; those with central nervous system side effects should avoid driving cars and operating machinery.

Medication for special populations:

Children: No safety and efficacy data are available in these patients. Valganciclovir hydrochloride tablets are not recommended for use in children because the pharmacokinetics of valganciclovir hydrochloride tablets in such patients have not been established.

Precautions during pregnancy and lactation: Pregnancy medication category C Because valganciclovir is rapidly and massively converted into ganciclovir, studies on its reproductive toxicity have not been repeated. In animal experiments, ganciclovir caused reduced fertility and teratogenicity. It is recommended that women of childbearing potential use effective contraceptive measures during treatment. Male patients are advised to use barrier contraception during treatment with valganciclovir hydrochloride tablets and for at least 90 days after discontinuation of treatment. There are no safety data on valganciclovir hydrochloride tablets during human pregnancy. Pregnant women should avoid the use of valganciclovir hydrochloride tablets unless the benefits to the mother far outweigh the potential harm to the fetus. The developmental effects of valganciclovir or cyclovir on the perinatal and postnatal infant have not been studied, but it must be considered that ganciclovir may be excreted in breast milk and cause serious adverse reactions in nursing infants. Therefore, when considering the possible benefit of the tablets to the nursing mother, the decision should be made to discontinue the medication.