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Viread
tenofovir disoproxil
Black Box Warnings .
Hepatitis B Exacerbation
severe acute exacerbations of hepatitis may occur in HBV-infected patients when D/C tenofovir; monitor hepatic function closely for at least several months after D/C tenofovir; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 300 mg; PWDR: 40 mg per scoop
HIV infection
- [300 mg PO qd]
- Info: give oral pwdr w/ soft food
hepatitis B infection, chronic
- [300 mg PO qd]
- Info: give oral pwdr w/ soft food
HIV post-exposure prophylaxis (off-label)
- [300 mg PO qd]
- Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables; give oral pwdr w/ soft food
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [300 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant patients w/ HBV DNA >200,000; 1st-line agent; give oral pwdr w/ soft food; D/C between birth to 3mo postpartum
renal dosing
- [see below]
- CrCl 30-49: 300 mg q48h; CrCl 10-29: 300 mg q72-96h; CrCl <10: avoid use
- HD: 300 mg q7 days, on dialysis days admin. after dialysis; no supplement; PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 150 mg, 200 mg, 250 mg, 300 mg; PWDR: 40 mg per scoop
HIV infection
- [2 yo and older, 10-16 kg]
- Dose: 8 mg/kg/dose PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 17-21 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 150 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 22-27 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 200 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 28-34 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 250 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, >35 kg]
- Dose: 8 mg/kg/dose PO qd; Max: 300 mg/day; Alt: 300 mg PO qd; Info: give oral pwdr w/ soft food
hepatitis B infection, chronic
- [2 yo and older, 10-16 kg]
- Dose: 8 mg/kg/dose PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 17-21 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 150 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 22-27 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 200 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, 28-34 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 250 mg PO qd; Info: give oral pwdr w/ soft food
- [2 yo and older, >35 kg]
- Dose: 8 mg/kg/dose PO qd; Max: 300 mg/day; Alt: 300 mg PO qd; Info: give oral pwdr w/ soft food
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [2-11 yo, 10-16 kg]
- Dose: 8 mg/kg/dose PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
- [2-11 yo, 17-21 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 150 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
- [2-11 yo, 22-27 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 200 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
- [2-11 yo, 28-34 kg]
- Dose: 8 mg/kg/dose PO qd; Alt: 250 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
- [2-11 yo, >35 kg]
- Dose: 8 mg/kg/dose PO qd; Max: 300 mg/day; Alt: 300 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
- [12 yo and older]
- Dose: 300 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table; give oral pwdr w/ soft food
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [300 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant patients w/ HBV DNA >200,000; 1st-line agent; give oral pwdr w/ soft food; D/C between birth to 3mo postpartum
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- nephrotoxic agent use, concurrent
- nephrotoxic agent use, recent
- CrCl <10 (patients not on hemodialysis)
- avoid: breastfeeding (patients w/ cracked nipple or bleeding nipple)
- avoid: breastfeeding (HIV infection use in patients w/ non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (HIV infection use in patients w/ non-virological suppression postpartum)
- avoid: breastfeeding (HIV infection use in patients w/ mastitis)
- avoid: breastfeeding (HIV post-exposure prophylaxis use)
- caution: renal impairment
- caution: renal disease risk
- caution: hepatic disease risk
- caution: HIV infection and HBV infection, concurrent
- caution: nucleoside tx, long-term
- caution: obesity
- caution: osteopenia
- caution: osteoporosis
- caution: fracture history, pathologic
Drug Interactions .
Overview
tenofovir disoproxil
NRTI
- BCRP substrate
- OAT1 substrate
- OAT3 substrate
- P-gp substrate
- intracellular phosphorylation inhibitor
- affected by altered fat absorption
- interferes w/ gene therapy
- nephrotoxicity
Contraindicated
- cidofovir
Avoid/Use Alternative
- adefovir dipivoxil
- aldesleukin
- alectinib
- amikacin
- amikacin inhaled
- amphotericin
- anthrax immune globulin
- aspirin
- atidarsagene autotemcel
- axitinib
- balsalazide
- betibeglogene autotemcel
- botulism immune globulin
- cabozantinib
- carboplatin
- carfilzomib
- celecoxib
- cisplatin
- clindamycin
- clofarabine
- cobicistat
- colistimethate
- creatine
- cyclophosphamide
- cytomegalovirus immune globulin
- darolutamide
- deferasirox
- deferoxamine
- diclofenac
- diclofenac topical
- etodolac
- fenoprofen
- flucytosine
- flurbiprofen
- ganciclovir
- ibuprofen
- ifosfamide
- immune globulin
- indomethacin
- iohexol
- iomeprol
- iopamidol
- ketorolac
- ledipasvir
- lenvatinib
- lifileucel
- lithium
- lutetium Lu 177 vipivotide tetraxetan
- meclofenamate
- mefenamic acid
- meloxicam
- mesalamine
- methotrexate
- mitomycin
- nabumetone
- naproxen
- neomycin
- nusinersen
- olsalazine
- oxaliplatin
- pamidronate
- paromomycin
- pazopanib
- penicillamine
- pentostatin
- plazomicin
- ramucirumab
- Rho(D) immune globulin
- rituximab
- ropeginterferon alfa-2b
- sitagliptin
- streptomycin
- streptozocin
- sulindac
- sunitinib
- tacrolimus
- telavancin
- tenofovir alafenamide
- tiopronin
- tivozanib
- tobramycin inhaled
- vaccinia immune globulin
- valganciclovir
- vancomycin
- venetoclax
- voclosporin
- willow bark
- zoledronic acid
Monitor/Modify Tx
- abrocitinib
- acalabrutinib
- adagrasib
- aliskiren
- amiloride
- amiodarone
- asciminib
- azilsartan medoxomil
- azithromycin
- belumosudil
- benazepril
- berotralstat
- bisoprolol
- bleomycin
- brigatinib
- canagliflozin
- candesartan cilexetil
- cannabidiol
- captopril
- chlorothiazide
- chlorthalidone
- cimetidine
- clarithromycin
- danicopan
- daridorexant
- diflunisal
- diltiazem
- diosmin
- dronedarone
- elacestrant
- elagolix
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- eltrombopag
- eluxadoline
- enalapril
- enalaprilat
- enasidenib
- encorafenib
- entrectinib
- enzalutamide
- erdafitinib
- ethacrynic acid
- febuxostat
- felodipine
- flibanserin
- fluvoxamine
- fosinopril
- fostamatinib
- furosemide
- futibatinib
- gilteritinib
- ginkgo
- grazoprevir
- hydrochlorothiazide
- ibrutinib
- imatinib
- imlunestrant
- indapamide
- irbesartan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- lapatinib
- lasmiditan
- lazertinib
- leflunomide
- lenacapavir
- leniolisib
- levoketoconazole
- lisinopril
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- losartan
- lumacaftor/ivacaftor
- magnesium citrate
- magnesium salicylate
- maribavir
- mavorixafor
- metolazone
- midostaurin
- mifepristone
- milk thistle
- mirabegron
- mitapivat
- moexipril
- momelotinib
- nefazodone
- nelfinavir
- neratinib
- nifedipine
- olmesartan medoxomil
- orlistat
- osimertinib
- pacritinib
- paroxetine
- perindopril
- pirtobrutinib
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- posaconazole
- pretomanid
- propafenone
- quercetin
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ramipril
- ranolazine
- regorafenib
- remibrutinib
- resmetirom
- rilzabrutinib
- ritonavir
- rolapitant
- rucaparib
- salsalate
- sarecycline
- selpercatinib
- sorafenib
- sotagliflozin
- sotorasib
- spironolactone
- stiripentol
- sulfate bowel prep
- sunvozertinib
- suvorexant
- tafamidis
- tedizolid phosphate
- telmisartan
- tepotinib
- teriflunomide
- tezacaftor/ivacaftor
- ticagrelor
- tolvaptan
- torsemide
- trandolapril
- trazodone
- triamterene
- trimethoprim
- trofinetide
- tucatinib
- turmeric
- uridine triacetate
- vadadustat
- valbenazine
- valsartan
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- verapamil
- vimseltinib
- voxilaprevir
- xanomeline
- zongertinib
- zonisamide
Caution Advised
- cabotegravir
- dichlorphenamide
- fexinidazole
- gemfibrozil
- meropenem
- nitisinone
- probenecid
- procainamide
- vaborbactam
Adverse Reactions .
Serious Reactions
- lactic acidosis
- hepatomegaly w/ steatosis
- hepatotoxicity
- HBV exacerbation, post-tx
- nephrotoxicity
- myopathy
- rhabdomyolysis
- osteomalacia
- fractures
- pancreatitis
- neutropenia
- hypersensitivity reaction
- immune reconstitution syndrome
- autoimmune disorder
Common Reactions
- rash
- hypercholesterolemia
- headache
- CK elevated
- pain
- diarrhea
- depression
- hyperamylasemia
- back pain
- fever
- nausea
- vomiting
- fatigue
- URI
- abdominal pain
- hematuria
- asthenia
- anxiety
- arthralgia
- myalgia
- insomnia
- pruritus
- pneumonia
- dyspepsia
- dizziness
- ALT or AST elevated
- glycosuria
- neutropenia
- Cr incr.
- bone density loss
Safety/Monitoring .
Monitoring Parameters
Adolescent or Adult Patients: Cr at baseline, 2-8wk after tx start or change, then q3-6mo; urinalysis at baseline if renal impairment or risk, then at least q6mo; LFTs at baseline, 2-8wk after tx start or change, then q3-6mo, then if HBV infection, continue for several mo after D/C; hepatitis B serology incl. HBsAg at baseline in patients w/ HIV infection; HIV screening at baseline in patients w/ HBV infection; phosphorus if chronic kidney disease; consider BMD if bone fracture history or osteopenia risk
Peds Patients: Cr at baseline, then q3-6mo; urinalysis at baseline if renal impairment or risk, then at least q3-6mo; LFTs at baseline, then q3-4mo, then if HBV infection, continue for several mo after D/C; hepatitis B serology incl. HBsAg at baseline in patients w/ HIV infection; HIV screening at baseline in patients w/ HBV infection; weight; phosphorus if chronic kidney disease; consider BMD if bone fracture history or osteopenia risk
Look/Sound-Alike Drug Names
Viread confused with: Venofer
tenofovir confused with: nelfinavir; trandolapril; Trizivir
Pregnancy/Lactation .
Pregnancy
Clinical Summary
benefits outweigh risks during pregnancy; drug of choice for HBV infection use during pregnancy; possible risk of low birth wt based on conflicting animal data
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
HIV Infection Use: weigh risk/benefit if virologically suppressed throughout 3rd trimester and at delivery, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis w/ zidovudine or nevirapine; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on human data; no known risk of infant harm, though possible risk of infant diarrhea based on limited human data; no human data available to assess effects on milk production
HIV Post-Exposure Prophylaxis Use: avoid breastfeeding; risk of postnatal HIV transmission if non-virologically suppressed based on human data; no human data available to assess effects on milk production
HBV Infection or Perinatal Prophylaxis Use: avoid breastfeeding if nipples cracked or bleeding, otherwise may use while breastfeeding; no known risk of infant harm, though possible risk of infant diarrhea based on limited human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: intracellular; CYP450: none; Info: prodrug converted to tenofovir
Excretion: urine primarily (32% unchanged); Half-life: 17h
Subclass: Hepatitis B (HBV) ; HIV: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Mechanism of Action
inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Gilead Sciences, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 150 mg (60 ea): $2,380.00
- 200 mg (30 ea): $1,195.00
- 250 mg (30 ea): $1,195.00
- 300 mg (30 ea): $1,288.00
oral powder:
- 40 mg/scoop (1 bottle of powder, 60 g): $707.00
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