Tenof

Tenofovir disoproxil fumarate

HIV-1 infection in adults & ped patients ≥12 yr in combination w/ other antiretrovirals. Chronic hepatitis B in adults.

Adult HIV-1 & chronic hepatitis B 300 mg once daily. Childn (≥12 yr & ≥35 kg) HIV-1 300 mg once daily. CrCl 30-49 mL/min 300 mg every 48 hr; CrCl 10-29 mL/min 300 mg every 72-96 hr. Hemodialysis 300 mg every 7 days or after approx 12 hr of dialysis.

May be taken with or without food.

Lactic acidosis & severe hepatomegaly w/ steatosis. Severe acute exacerbations of hepatitis upon discontinuation of anti-hepatitis B therapy. New onset or worsening renal impairment including acute renal failure & Fanconi syndrome. Persistent or worsening bone pain, pain in extremities, fractures &/or muscular pain/weakness. Risk of developing HIV-1 resistance in patients coinfected w/ HIV-1 & HBV. Decreased bone mineral density. History of pathologic bone fracture or risk factors for osteoporosis or bone loss; hypophosphatemia & osteomalacia associated w/ proximal renal tubulopathy. Immune reconstitution syndrome; autoimmune disorders eg, Graves’ disease, polymyositis, Guillain-Barre syndrome. Early virologic failure. Assess CrCl, serum P, urine glucose & protein prior to therapy. Monitor triple nucleoside-only regimens & consider treatment modification. Monitor hepatobiliary & renal parameters in HBV-infected patients w/ decompensated liver disease & have Child-Pugh-Turcotte score >9. Avoid use w/ nephrotoxic agent eg, high-dose or multiple NSAIDs. Not to be used in combination w/ other tenofovir disoproxil fumarate- or alafenamide-containing drugs & adefovir dipivoxil. Not to be used co-administered w/ atazanavir w/o ritonavir. Monitor tenofovir-associated ARs in concomitant use w/ lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir, sofosbuvir/velpatasvir/voxilaprevir combination. Moderate or severe renal impairment; end-stage renal disease requiring dialysis. Pregnancy. Avoid use during lactation. Childn <12 yr. Elderly.

Rash, diarrhea, headache, pain, depression, asthenia & nausea; abdominal pain, insomnia, pruritus, vomiting, dizziness & pyrexia.

Increased AUC & C_max of didanosine. Decreased AUC & C_max of atazanavir. Increased absorption w/ P-glycoprotein & breast cancer resistance protein transporter inhibitors. Increased serum conc w/ drugs affecting renal function eg, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, gentamicin & high-dose or multiple NSAIDs. Increased exposure w/ sofosbuvir/velpatasvir, ledipasvir/sofosbuvir or ofosbuvir/velpatasvir/voxilaprevir.

Antivirals

J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

POM