Truvada

Truvada

tenofovir + emtricitabine

Manufacturer:

Gilead

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg (equiv to 245 mg tenofovir disoproxil)
Indications/Uses
In combination w/ other antiretroviral agents eg, NNRTIs or PIs for HIV-1 infection in adults.
Dosage/Direction for Use
Adult 1 tab once daily. Renal impairment CrCl ≥50 mL/min Recommended dosing interval: Every 24 hr; CrCl 30-49 mL/min Recommended dosing interval: Every 48 hr.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if didanosine-associated adverse events; lactic acidosis or pronounced hepatotoxicity develops. Not recommended to use as component of triple nucleoside regimen. Lactic acidosis & severe hepatomegaly w/ steatosis; severe acute exacerbations of hepatitis B; osteomalacia associated w/ proximal renal tubulopathy. Immune reconstitution syndrome. Redistribution or accumulation of body fat in patients receiving antiretroviral therapy. Perform test for presence of chronic HBV prior to antiretroviral therapy; routine monitoring of calculated CrCl & serum P in patients at risk for renal impairment. Closely monitor hepatic function w/ both clinical & lab follow up for at least several mth in patients who are co-infected w/ HIV & HBV. Consider bone monitoring for HIV infected patients w/ history of pathologic bone fracture or at risk for osteopenia. Avoid concurrent or recent use of nephrotoxic agent. Not to co-administered w/ Atripla, Emtriva, or Viread; other lamivudine-containing drugs eg, Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine); atazanavir. Acute renal failure & Fanconi syndrome (renal tubular injury w/ severe hypophosphatemia). Not to be administered in patients w/ CrCl <30 mL/min & ESRD requiring hemodialysis. Hepatic impairment. Pregnancy. Not to breastfeed during treatment. Not recommended in childn <18 yr. Elderly >65 yr.
Adverse Reactions
Diarrhea, nausea, vomiting; fatigue; sinusitis, URTI, nasopharyngitis; somnolence, headache, dizziness; depression, insomnia, abnormal dreams; rash. Allergic reaction; hypophosphatemia, lactic acidosis; dyspnea; abdominal pain, increased amylase, pancreatitis; increased liver enzymes, hepatitis; myopathy, osteomalacia; renal insufficiency & failure, acute renal failure, Fanconi syndrome, proximal tubulopathy, proteinuria, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, polyuria, interstitial nephritis; asthenia.
Drug Interactions
Potentiated didanosine-associated adverse events eg, pancreatitis & nephropathy w/ didanosine. Increased tenofovir conc w/ atazanavir & lopinavir/ritonavir. Decreased AUC & Cmin of atazanavir. Increased serum conc w/ drugs reducing renal function or competing active tubular secretion eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, & valganciclovir.
MIMS Class
Antivirals
ATC Classification
J05AR03 - tenofovir disoproxil and emtricitabine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Truvada FC tab
Packing/Price
30's
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