TRUVADA (emtricitabine and tenofovir disoproxil fumarate) is a two-drug formulation of nucleoside analog reverse transcriptase inhibitors (NRTI), used for the treatment of HIV-1 infection, in combination with other antiretroviral drugs.
Dosing & Administration
TRUVADA is indicated for the treatment of HIV-1 infection in adults and children weighing 17kg or more. TRUVADA is also indicated for pre-exposure HIV-1 prophylaxis (PrEP) for sexual contact for at-risk adults and adolescents weighing at least 35kg. Off-label uses include post-exposure HIV-1 prophylaxis in occupational / non-occupational settings, including after sexual assault. Dosages details based on patient weight are in the package insert.
TRUVADA should not be taken for PrEP if the patient is positive for HIV-1 infection or HIV-1 status is unknown. TRUVADA itself is not a complete treatment for HIV-1 since other medications are necessary to be taken with it.
The most common effects are nausea, diarrhea, headache, fatigue, rash, abnormal dreams, depression, dizziness, and insomnia. Weight loss and abdominal pain are less common. A complete list of effects is in the package insert.
Severe acute hepatitis B virus (HBV) exacerbations have been reported in HBV-infected patients who have stopped TRUVADA treatment. Therefore, hepatic function should be monitored in those patients.
When using this product for HIV-1 PrEP, it must be for confirmed HIV-negative patients immediately prior to initial use and periodically during use. There have been drug-resistant HIV-1 variants with the use of TRUVADA for HIV-1 PrEP following undetected acute HIV-1 infection.
The use of this drug has been associated with new onset or worsening renal impairment including acute renal failure and Fanconi syndrome. TRUVADA should not be used concurrently or if recent use of nephrotoxic drugs has occurred.
Immune reconstitution syndrome may occur as immune systems of patients become stronger. Hidden infections may be fought and new symptoms may occur. As a result, further evaluation and treatment may be needed.
Decreases in bone mineral density (BMD) may occur due to TRUVADA. Those with a history of pathologic fracture or other risk factors for osteoporosis or bone loss should be assessed.
Lactic acidosis/severe hepatomegaly with steatosis is another effect from TRUVADA. This serious but rare effect should result in the patient being discontinued from treatment if symptoms develop or laboratory findings are present.
TRUVADA is associated with a number of drug-drug interactions and prescribers should familiarize themselves with the list provided in the package insert.
Pregnancy & Lactation
Whether or not TRUVADA can harm an unborn baby is unknown. A pregnancy registry for women who take TRUVADA during pregnancy exists. The registry is in place to collect information about the health of the patient and the baby.
It is not known if TRUVADA affects milk production or can have effects on the breastfed child. It is recommended that HIV-1 infected mothers not breastfeed their infants to avoid risking transmission of HIV-1.
If overdose of TRUVADA occurs, patients must be monitored for toxicity. Both components of TRUVADA can be partially removed by hemodialysis.
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