TIVICAY (dolutegravir) is an Integrase Strand Transfer Inhibitor (INSTI) drug used for the treatment of HIV infection. It is indicated as part of a combination regimen with other antiretrovirals in patients who are INSTI-naïve, or for INSTI-exposed adults with certain profiles of HIV resistance. Dolutegravir inhibits the action of the HIV replication enzyme integrase, thereby disrupting the completion of infectious virions.
Dosing & Administration
TIVICAY is indicated for the treatment of HIV infection, and off-label for HIV post-exposure prophylaxis following occupational or non-occupational exposure, including sexual assault. Patient selection for TIVICAY therapy is subject to a number of limitations, so the product monograph and current treatment guidelines should be closely reviewed. It is always used in combination with other antiretroviral drugs and may be used in adults and children weighing 30 kg or more. TIVICAY is available in film-coated tablets, which may be scored or crushed. It can be taken with or without food. TIVICAY requires dosage increases when used with certain other medications. Dosages and prescribing considerations are detailed in the product monograph.
TIVICAY can be used without dosage adjustment in patients with mild or moderate hepatic impairment, but should not be used in severe hepatic impairment. No dose adjustments are necessary in patients with mild to moderate renal dysfunction, but added caution and dosage changes are needed in severe renal impairment, as detailed in the product monograph.
TIVICAY is contraindicated in patients with hypersensitivity to the drug, or who are taking dofetilide.
TIVICAY is associated with osteonecrosis, hepatotoxicity, viral resistance, immune reactivation syndrome, and rash. A more complete list of potential adverse effects is provided in the product monograph.
Serious, even fatal rashes and organ dysfunction related to hypersensitivity reactions have been reported in patients taking TIVICAY.
TIVICAY is associated with an increased risk of depression and suicidal ideation/behavior, especially in patients with a pre-existing psychiatric illness.
All patients who test positive for HIV infection should be screened for comorbid HBV and Hepatitis C virus (HCV) infection. Co-infected patients should be started on an antiretroviral regimen targeting co-infected viruses, regardless of CD4 counts or viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
TIVICAY is associated with a large number of drug-drug and herbal interactions, cautions, and contraindications. These are listed in the product monograph.
Pregnancy & Lactation
Highly active retroviral combination treatment should be used in all pregnant women, regardless of viral load and CD4 count. TIVICAY is associated with neural tube defects when used in the first trimester of pregnancy. Current guidelines should be consulted when treating pregnant women, or women who may become pregnant. Excretion of dolutegravir in breast milk is unknown. The CDC recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
TIVICAY overdose should be treated with standard supportive care and monitoring. Dolutegravir is probably not dialyzable.
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