Truvada is single-pill, fixed dose combination drug comprised of two antiretroviral agents, tenofovir and emtricitabine, both classified as nucleotide reverse transcriptase inhibitors. The two drug components are independently marketed as Viread (tenofovir) and Emtriva (emtricitabine, FTC).
Truvada was approved by the U.S. Food and Drug Administration (FDA) in August 2004 for use in the treatment of HIV, specifically for adults and children over the age of 12 who weigh 77 pounds (35kg) or more.
TRUVADA Rx
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TRUVADA
Viral infections Only 4 drugs may be compared at once
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Generic Name and Formulations:
Emtricitabine, tenofovir disoproxil fumarate; 100mg/150mg, 133mg/200mg, 167mg/250mg, 200mg/300mg; tabs.
Company:
Gilead Sciences, Inc.
Select therapeutic use: Viral infections
Indications for TRUVADA:
HIV-1 infection, in combination with other antiretroviral agents. Pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 in high-risk adults in combination with safer sex practices.
Adult:
HIV-1 infection: ≥35kg: 200mg/300mg once daily. Renal impairment: CrCl 30–49mL/min: 200mg/300mg every 48hrs; CrCl <30mL/min, hemodialysis: not recommended. PrEP: Confirm negative HIV-1 test immediately prior to initiating, repeat at least every 3 months. 200mg/300mg once daily. CrCl<60mL/min: do not use.
Children:
HIV-1 infection: <17kg: not established. 17–<22kg: 100mg/150mg once daily. 22–<28kg: 133mg/200mg once daily. 28–<35kg: 167mg/250mg once daily. ≥35kg: 200mg/300mg once daily.
Contraindications:
PrEP in individuals with unknown or positive HIV-1 status.
Warnings/Precautions:
Risk of lactic acidosis or severe hepatomegaly with steatosis; suspend if occurs. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Not for treating chronic hepatitis B; test for HBV before starting therapy and monitor patients co-infected with HIV-1 and HBV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Assess CrCl prior to initiating therapy in all patients. Monitor CrCl, serum phosphorus, urine glucose and protein prior to initiation and periodically during therapy in patients at risk for renal impairment. History or risk of fractures or osteopenia: monitor bone mineral density (BMD); consider Vit. D and calcium supplementation. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. PrEP: counsel patients about safe sex practices and eva luate for symptoms consistent with acute viral infection.
Interactions:
Avoid concomitant drugs that contain emtricitabine, tenofovir disoproxil fumarate, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Potentiates didanosine toxicity (>60kg: reduce dose of didanosine); discontinue didanosine if toxicity develops. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose NSAIDs). Avoid concomitant or recent use of nephrotoxic agents. Potentiated by lopinavir/ritonavir, ritonavir-boosted atazanavir or darunavir; monitor for toxicity; discontinue if occurs. Concomitant atazanavir: must give with ritonavir. Tenofovir levels increased by ledipasvir/sofosbuvir: monitor for toxicity; consider alternative HCV or antiretroviral therapy if boosted with ritonavir or cobicistat. Caution with triple nucleoside-only regimen (high rate of early viral non-response); monitor and consider alternative therapy. See full labeling for dosing of concomitant didanosine or ritonavir.
Pharmacological Class:
Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).
Adverse Reactions:
Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, weight decreased; infections, fat redistribution, immune reconstitution syndrome, lactic acidosis, severe hepatomegaly w. steatosis, new or worsening renal impairment, decreased BMD, severe acute exacerbations of hepatitis B.
Note:
Register pregnant patients exposed to Truvada by calling (800) 258-4263.
Metabolism:
Emtricitabine: hepatic; tenofovir DF: remains largely unchanged.
Elimination:
Renal.
REMS:
YES
Generic Availability:
NO
How Supplied:
Tabs—30 |
