Truvada (emtricitabine/tenofovir disoproxil fumarate)

TRUVADA (emtricitabine/tenofovir disoproxil fumarate) – a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors commonly used to treat infection by the human immunodeficiency virus (HIV).

FDA approved uses: Truvada is indicated for use in combination with other antiretroviral agents to treat adult and pediatric (age 12 years or older) infections with the HIV-1 virus. Truvada is also indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Available dosage forms: Tablet containing 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate.

Usual dosage: Treatment of HIV-1 infection – Recommended dose in adults and pediatric patients (12 years of age and older and weighing greater than or equal to 35 kg): One tablet once daily taken orally with or without food. Recommended dose in renally impaired HIV-1 infected adult patients: Creatinine clearance 30-49 mL/min: 1 tablet every 48 hours. CrCl below 30 mL/min or hemodialysis: Do not use TRUVADA. Pre0exposure prophylaxis – Recommended dose in HIV-1 uninfected adults: One tablet once daily taken orally with or without food. Recommended dose in renally impaired HIV-uninfected individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

Contraindications: Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agents.

Special Warnings: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued TRUVADA. Therefore, hepatic function should be monitored closely in HBV-infected patients who discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted. TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Drug-resistant HIV-1 variants have been identified with the use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.

Adverse reactions (side effects) of these medications: The most common side effects of Truvada in the treatment of HIV-1 include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. For PrEP, the most common reactions were: headache, abdominal pain and weight increase. Other adverse reactions seen in clinical trials or post-marketing include: Vomiting, sinusitis, upper respiratory infection, nasopharyngitis, depression, insomnia, hypercholesterolemia, increases in serum amylase, neutrophils, triglycerides, AST, ALT, alkaline phosphatase, or blood glucose, hematuria, glucosuria, myalgia, back pain, parasthesia, peripheral neuropath, pneumonia, and rhinitis.

Common drug interactions: Clinically relevant drug interactions were seen in clinical trials with Truvada. A list of drugs reported to interact with Truvada includes, but is not limited to, didanosine, atazanavir, and lopinavir/ritonavir. Coadministration of TRUVADA with drugs that are eliminated by active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the coadministered drug. Some examples include, but are not limited to acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, and valganciclovir. Drugs that decrease renal function may increase concentrations of emtricitabine and/or tenofovir.

Special instructions for patients: TRUVADA is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using TRUVADA. It is important to take Truvada on a regular dosing schedule with combination therapy to avoid missing doses. Patients should not share needles or other injection equipment. Do not share personal items that may have blood or other bodily fluids on them. Do not have any kind of sex without protection. Do not breastfeed while taking this medication. Truvada may cause redistribution of body fat. Notify doctor if disease worsens or unusual symptoms are experienced. When taking Truvada to prevent HIV-1 infection, confirm uninfected status before starting regimen. Truvada should only be used as part of a complete prevention strategy including other prevention measures. Consult patient medication guide before starting treatment.

Full prescribing information may be found at the manufacturer‘s official website Truvada.com or at the U.S. Food and Drug Administration’s website at Truvada Info at Drugs@FDA

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