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The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
Patients should be advised that VISTIDE (cidofovir) is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during and following treatment. Patients receiving VISTIDE (cidofovir) should be advised to have regular follow-up ophthalmologic examinations. Patients may also experience other manifestations of CMV disease despite VISTIDE (cidofovir) therapy.
HIV-infected patients may continue taking antiretroviral therapy, but those taking zidovudine should be advised to temporarily discontinue zidovudine administration or decrease their zidovudine dose by 50%, on days of VISTIDE (cidofovir) administration only, because probenecid reduces metabolic clearance of zidovudine.
Patients should be informed of the major toxicity of VISTIDE (cidofovir) , namely renal impairment, and that dose modification, including reduction, interruption, and possibly discontinuation, may be required. Close monitoring of renal function (routine urinalysis and serum creatinine) while on therapy should be emphasized.
The importance of completing a full course of probenecid with each VISTIDE (cidofovir) dose should be emphasized. Patients should be warned of potential adverse events caused by probenecid (e.g., headache, nausea, vomiting, and hypersensitivity reactions). Hypersensitivity/allergic reactions may include rash, fever, chills and anaphylaxis. Administration of probenecid after a meal or use of antiemetics may decrease the nausea. Prophylactic or therapeutic antihistamines and/or acetaminophen can be used to ameliorate hypersensitivity reactions.
Patients should be advised that cidofovir causes tumors, primarily mammary adenocarcinomas, in rats. VISTIDE (cidofovir) should be considered a potential carcinogen in humans (See Carcinogenesis, Mutagenesis, & Impairment of Fertility). Women should be advised of the limited enrollment of women in clinical trials of VISTIDE (cidofovir) .
Patients should be advised that VISTIDE (cidofovir) caused reduced testes weight and hypospermia in animals. Such changes may occur in humans and cause infertility. Women of childbearing potential should be advised that cidofovir is embryotoxic in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for 1 month following treatment with VISTIDE (cidofovir) . Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with VISTIDE (cidofovir) .
Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Vistide Information
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