Select therapeutic use:
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.
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.
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.
PrEP in individuals with unknown or positive HIV-1 status.
Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. PrEP: counsel patients about safer sex practices and evaluate for symptoms consistent with acute viral infection. Pregnancy (Cat.B). Nursing mothers: not recommended.
Avoid concomitant drugs that contain emtricitabine, tenofovir DF, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Potentiates didanosine toxicity (>60kg: reduce dose of didanosine); discontinue didanosine if toxicity develops. Avoid concomitant or recent use of nephrotoxic agents. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). 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 concomitant ledipasvir/sofosbuvir or sofosbuvir/velpatasvir; monitor for toxicity. Caution with triple nucleoside-only regimen (high rate of early virologic failure); monitor and consider alternative therapy. See full labeling for dosing of concomitant didanosine or ritonavir.
Nucleoside/nucleotide analogue (reverse transcriptase inhibitors).
Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, weight decreased; decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome.
Register pregnant patients exposed to Truvada by calling (800) 258-4263.
Emtricitabine: hepatic; tenofovir DF: remains largely unchanged.