TIVICAY (dolutegravir) is an Integrase Strand Transfer Inhibitor (INSTI) drug that treats HIV. It is used in combination with other antiretrovirals for those who are INSTI-naïve, or for INSTI-exposed adults with certain profiles of resistance to HIV. TIVICAY stops the HIV replication of the integrase enzyme which halts the completion of infectious virions.
Dosing & Administration
TIVICAY is used to treat HIV, and off-label for HIV post-exposure prophylaxis which follows either an occupational or non-occupational exposure, including sexual assault. TIVICAY therapy has several limitations, so the package insert and specific guidelines regarding treatment need to be monitored. TIVICAY is used together with other antiretroviral drugs and may be used in adults and children (weighing 30 kg or more). This drug is available as a tablet that is film coated. It may be crushed or scored. It can be taken with or without food. Dosage increases are necessary when TIVICAY is used with other specific medications. Refer to the package insert for details regarding prescribing considerations and dosages.
For patients with mild or moderate hepatic impairment, TIVICAY can be used without dosage adjustment. However, this drug should not be used for those with severe hepatic impairment. Patients with mild to moderate renal dysfunction do not require dose adjustments, but dosage changes will be needed for those in sever renal impairment. Further details are provided in the package insert.
TIVICAY is contraindicated in patients who are currently taking dofetilide or those with hypersensitivity to the drug.
There are side effects listed with TIVICAY, which include immune reactivation syndrome, osteonecrosis, hepatotoxicity, viral resistance, and a rash. A detailed list of potential side effects is available in the package insert.
Some patients taking TIVICAY have reported serious, even fatal rashes and organ dysfunction related to hypersensitivity reactions.
The use of TIVICAY has also been associated with an increased risk of suicidal ideation/behavior and depression, with a higher incidence in patients who have a pre-existing psychiatric illness.
HIV positive patients must be tested for comorbid HBV and HCV infection. Patients who are co-infected should be started on an antiretroviral regimen that will target co-infected viruses, regardless of CD4 counts or viral loads. Drug regimens and prescribing considerations are outlined in the current HIV treatment guidelines.
There are a large number of herbal and drug-to-drug interactions, cautions and contraindications for TIVICAY. More details are listed in the package insert.
Pregnancy & Lactation
Pregnant women with HIV should use a highly active retroviral combination treatment regardless of viral load and CD4 count. There are high risks of neural tube defects when TIVICAY is used during the first 12 weeks of a pregnancy. When treating pregnant women, or women who might become pregnant, current guidelines should be consulted. It is unknown if TIVICAY is transmitted through breast milk, however it is recommended that HIV positive women refrain from breastfeeding.
Standard supportive care and monitoring should be used in the case of an TIVICAY overdose. Dolutegravir is probably not dialyzable.
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