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It is produced and developed by the Swiss company Roche. In May 2001, it was approved by the US FDA for marketing. Valcyte hydrochloride is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte hydrochloride is 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 for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

The recommended induction dose of valganciclovir hydrochloride tablets for the treatment of cytomegalovirus retinitis is 900 mg (two 450 mg tablets) twice daily for 21 days. Maintenance: After induction therapy, or in adult patients with inactive cytomegalovirus retinitis, the recommended dose is 900 mg orally once daily.

Valganciclovir hydrochloride tablets are the L-valyl ester (prodrug) of ganciclovir. After oral administration, it is rapidly converted into ganciclovir by esterases in the small intestine and liver. Ganciclovir is a synthetic analog of 2’-deoxyguanosine that inhibits herpes virus replication in vitro and in vivo. The antiviral effect of valganciclovir hydrochloride tablets has been clinically confirmed by treating AIDS patients with newly diagnosed retinitis (clinical study WV15376). After 4 weeks of treatment with valganciclovir hydrochloride tablets, the detection rate of CMV virus decreased from 46% (32/69) to 7% (4/55).

Use with caution in patients with impaired renal function; dose adjustment required. Acute renal failure may occur in elderly patients with or without renal impairment; elderly patients should be used with caution and dosage adjustments based on renal function.

May temporarily or permanently inhibit sperm production and suppress fertility; may cause birth defects and cancer in humans. Due to its teratogenicity, women should take a pregnancy test before initiating pregnancy and use effective contraception during treatment and for 30 days after treatment; men should use barrier contraception during treatment and for 90 days after treatment.