NORVIR (ritonavir) is a protease inhibitor (PI) drug indicated for use in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV-1) infection. NORVIR works by interfering with the replication of the HIV virus by competitively inhibiting HIV protease in its role in producing mature virions, thus rendering the virus non-infectious
NORVIR is indicated for the treatment of HIV-1 infection in adult patients and children greater than one month old. This product has been shown to help for non-occupational post-exposure prophylaxis. Dosage regimens are weight- and indication-specific and are detailed in the package insert. NORVIR is available in oral liquid and powder preparations.
NORVIR may be used in patients with mild or moderate hepatic impairment without dose adjustment. However, transaminase level monitoring should be considered in these patients due to risk of elevation during treatment with NORVIR. NORVIR should not be used in patients with severe hepatic impairment due to lack of data to support its safety and efficacy. Ritonavir pharmacokinetics have not been studied in patients with renal impairment. Renal clearance has been shown to be negligible and therefore, a decrease in total body clearance is not expected in patients with renal impairment.
All patients with HIV infection should be screened for comorbid hepatitis B virus (HBV) infection. Co-infected patients should be started on an antiretroviral regimen targeting both viruses, regardless of cluster of differentiation (CD4) counts or HBV viral loads. Treatment should be continued indefinitely to achieve HIV suppression and prevention of HBV activation. Likewise, HIV-positive patients should be tested for Hepatitis C virus (HCV), and regular ongoing testing for those deemed to be at high risk. If HIV/HCV co-infection is identified, consideration should be given to treating both infections concurrently.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NORVIR during pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The Centers of Disease Control (CDC) recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
NORVIR comes with a box warning of potentially serious, even fatal drug-drug interactions with several drug classes, including some anti-arrhythmics, sedative-hypnotics, and ergot alkaloids. Potential drug-drug interactions and potential adverse effects for patients using NORVIR are detailed in the package insert and should be consulted by all prescribers.
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