ISENTRESS (raltegravir) is an Integrase Strand Transfer Inhibitor (INSTI) drug indicated for the treatment of human immunodeficiency virus (HIV-1) infection as part of a combination regimen with other antiretrovirals.
ISENTRESS is indicated for adult patients and pediatric patients based on age and weight. ISENTRESS 400mg is available as film-coated tablets for oral use. ISENTRESS is used for treatment naïve and treatment experienced patients. Dosing guidance including pediatric weight and age considerations can be consulted in the package insert. Other formulations and dosages are available including chewable and oral suspension.
ISENTRESS has been shown to help for HIV post-exposure prophylaxis following occupational exposure as part of a three-drug regimen. Prophylaxis should begin as soon as possible after exposure. Delaying initiation of treatment after exposure may result in a significant reduction in efficacy.
ISENTRESS has also been shown to help as part of a three-drug post-exposure prophylaxis regimen following non-occupational exposure, including sexual assault. In addition, ISENTRESS could help for perinatal HIV prophylaxis in neonates at high risk for HIV infection, as part of a three-drug antiretroviral regimen.
ISENTRESS can be used without dosage adjustment in patients with mild or moderate hepatic impairment, but must be used with caution in patients with severe hepatic impairment. No dose adjustments are necessary in patients with renal impairment, but the extent to which ISENTRESS is dialyzed is unknown. The effect of severe hepatic impairment on the pharmacokinetics of raltegravir has not been studied.
All patients presenting with HIV infection should be tested for comorbid Hepatitis C virus (HCV) infection, and re-tested annually or as clinically indicated if they are at elevated risk for HCV infection. Consideration should be given to treating both infections concurrently in patients co-infected with HIV and HCV. Likewise, all HIV-positive patients should be screened and treated for comorbid Hepatitis B virus (HBV).
Adequate studies have not taken place for the use of this product in pregnant women. The Centers for Disease Control (CDC) recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus. A pregnancy exposure registry that monitors outcomes of exposure is in place. The purpose of this registry is to collect information about the patient’s and baby’s health.
Serious, even fatal rashes and organ dysfunction related to hypersensitivity reactions have been reported in patients taking ISENTRESS. Prescribers should familiarize themselves with the potential adverse reactions and drug-drug interactions in the package insert.
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