Dosing & Uses
Dosage Forms & Strengths
tenofovir disoproxil fumarate (ie, tenofovir DF)
tablet
- 150mg
- 200mg
- 250mg
- 300mg
powder, oral
- 40mg/g of powder (ie, 1 scoopful)
HIV Infection
Indicated in combination with other antiretroviral agents for treatment of HIV-1 infection
300 mg PO qDay
Also available combined with emtricitabine (Truvada), emtricitabine/efavirenz (Atripla), emtricitabine/rilpivirine (Complera)
Hepatitis B Infection
Indicated for chronic hepatitis B
300 mg PO qDay
Renal Impairment
CrCl ≥50 mL/min: No dosage adjustment necessary
CrCl 30-49 mL/min: 300 mg PO q48hr
CrCl 10-29 mL/min: 300 mg PO q72-96hr
CrCl <10 mL/min: Not studied
Hemodialysis: 300 mg PO q7Days or after a total of ~12hr of dialysis
Hepatitis B Transmission (Orphan)
Orphan designation for prevention of mother-to-child transmission of hepatitis B virus
Sponsor
- Gilead Sciences, Inc; 333 Lakeside Drive; Foster City, California 94404
Dosing Considerations
Before starting treatment, test for HBV and HIV-1 infection
Assess serum creatinine, estimated CrCl, urine glucose and urine protein in all patients
In patients with chronic kidney disease, also assess serum phosphorus
Dosage Forms & Strengths
tenofovir disoproxil fumarate (ie, tenofovir DF)
tablet
- 150mg
- 200mg
- 250mg
- 300mg
powder, oral
- 40mg/g of powder (ie, 1 scoopful)
HIV Infection
Indicated for treatment of HIV infection in combination with other antiretroviral agents in children aged 2 years or older
<2 years: Safety and efficacy not established
≥2 years and weigh (≥10 kg): 8 mg/kg PO qDay; not to exceed 300 mg/day
Oral powder
- 10 to <12 kg: 80 mg (2 scoops) PO qDay
- 12 to <14 kg: 100 mg (2.5 scoops) PO qDay
- 14 to <17 kg: 120 mg (3 scoops) PO qDay
- 17 to <19 kg: 140 mg (3.5 scoops) PO qDay
- 19 to <22 kg: 160 mg (4 scoops) PO qDay
- 22 to <24 kg: 180 mg (4.5 scoops) PO qDay
- 24 to <27 kg: 200 mg (5 scoops) PO qDay
- 27 to <29 kg: 220 mg (5.5 scoops) PO qDay
- 29 to <32 kg: 240 mg (6 scoops) PO qDay
- 32 to <34 kg: 260 mg (6.5 scoops) PO qDay
- 34 to <35 kg: 280 mg (7 scoops) PO qDay
- ≥35 kg: 300 mg (7.5 scoops) PO qDay
Tablet
- 17 to <22 kg: 150 mg PO qDay
- 22 to <28 kg: 200 mg PO qDay
- 28 to <35 kg: 250 mg PO qDay
- ≥35 kg: 300 mg PO qDay
Hepatitis B Infection
Indicated for chronic hepatitis B in children aged 2 years or older
<2 years: Safety and efficacy not established
≥2 years and weigh (≥10 kg): 8 mg/kg PO qDay; not to exceed 300 mg/day
Oral powder
- 10 to <12 kg: 80 mg (2 scoops) PO qDay
- 12 to <14 kg: 100 mg (2.5 scoops) PO qDay
- 14 to <17 kg: 120 mg (3 scoops) PO qDay
- 17 to <19 kg: 140 mg (3.5 scoops) PO qDay
- 19 to <22 kg: 160 mg (4 scoops) PO qDay
- 22 to <24 kg: 180 mg (4.5 scoops) PO qDay
- 24 to <27 kg: 200 mg (5 scoops) PO qDay
- 27 to <29 kg: 220 mg (5.5 scoops) PO qDay
- 29 to <32 kg: 240 mg (6 scoops) PO qDay
- 32 to <34 kg: 260 mg (6.5 scoops) PO qDay
- 34 to <35 kg: 280 mg (7 scoops) PO qDay
- ≥35 kg: 300 mg (7.5 scoops) PO qDay
Tablet
- 17 to <22 kg: 150 mg PO qDay
- 22 to <28 kg: 200 mg PO qDay
- 28 to <35 kg: 250 mg PO qDay
- ≥35 kg: 300 mg PO qDay
Dosage Modifications
Renal impairment: No data available for dosage recommendations
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (3)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
tenofovir DF, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
- fezolinetant
tenofovir DF will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors
- streptozocin
streptozocin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Contraindicated. Streptozocin should not be used in combination with or concomitantly with other potential nephrotoxins.
Serious - Use Alternative (14)
- adefovir
adefovir, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced nephrotoxicity. Avoid coadministration.
adefovir increases levels of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. Avoid coadministration. - bacitracin
tenofovir DF and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
- betibeglogene autotemcel
tenofovir DF, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
- cabotegravir
tenofovir DF, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
- cyclosporine
cyclosporine and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug.
- dabigatran
tenofovir DF will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran
- edoxaban
tenofovir DF will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers
- elivaldogene autotemcel
elivaldogene autotemcel, tenofovir DF. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- lasmiditan
lasmiditan increases levels of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
lasmiditan increases levels of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates. - leniolisib
leniolisib will increase the level or effect of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates
- letermovir
tenofovir DF will decrease the level or effect of letermovir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Coadministration of letermovir with P-gp inducers is not recommended.
- nintedanib
tenofovir DF decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- sotorasib
sotorasib will decrease the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tepotinib
tepotinib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
Monitor Closely (116)
- abacavir
abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- acalabrutinib
acalabrutinib increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.
- acyclovir
acyclovir and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
acyclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. - aldesleukin
aldesleukin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
aldesleukin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - amikacin
amikacin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
amikacin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - amiloride
tenofovir DF increases levels of amiloride by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- amphotericin B cholesteryl sulfate
amphotericin B cholesteryl sulfate and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B deoxycholate
amphotericin B deoxycholate and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B liposomal
amphotericin B liposomal and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B phospholipid complex
amphotericin B phospholipid complex and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- apalutamide
apalutamide will decrease the level or effect of tenofovir DF by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.
- atazanavir
atazanavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tenofovir DF decreases levels of atazanavir by unknown mechanism. Use Caution/Monitor. May result in loss of atazanavir antiviral activity; ritonavir boosting may help to compensate. - berotralstat
berotralstat will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bleomycin
bleomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- capreomycin
capreomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- carboplatin
carboplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- celecoxib
tenofovir DF, celecoxib. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- cidofovir
cidofovir and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
cidofovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. - cimetidine
cimetidine, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- cisplatin
cisplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
cisplatin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - colistin
colistin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- contrast media (iodinated)
contrast media (iodinated) and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.
- darolutamide
darolutamide will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).
- dichlorphenamide
dichlorphenamide and tenofovir DF both decrease serum potassium. Use Caution/Monitor.
- diclofenac
tenofovir DF, diclofenac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- didanosine
tenofovir DF increases toxicity of didanosine by decreasing elimination. Use Caution/Monitor. May increase risk of pancreatitis; decrease didanosine dose to 250 mg/day if weight >60 kg and decrease to 200 mg/day if weight <60 kg .
- diflunisal
tenofovir DF, diflunisal. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- digoxin
tenofovir DF increases levels of digoxin by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- dofetilide
tenofovir DF increases levels of dofetilide by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- duvelisib
tenofovir DF will decrease the level or effect of duvelisib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- efavirenz
efavirenz and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- elagolix
elagolix will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- emtricitabine
emtricitabine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- encorafenib
encorafenib will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a BCRP inhibitor) may increase the concentration and toxicities of BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.
- enfuvirtide
enfuvirtide and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- entecavir
tenofovir DF increases levels of entecavir by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. Both drugs are excreted by active tubular secretion.
- etodolac
tenofovir DF, etodolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- famciclovir
tenofovir DF increases levels of famciclovir by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- fenofibrate
fenofibrate increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenofibrate micronized
fenofibrate micronized increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenofibric acid
fenofibric acid increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenoprofen
tenofovir DF, fenoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- flucytosine
flucytosine, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
flucytosine increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - flurbiprofen
tenofovir DF, flurbiprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- fosamprenavir
fosamprenavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- foscarnet
foscarnet and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- fostamatinib
fostamatinib will increase the level or effect of tenofovir DF by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- ganciclovir
ganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- gentamicin
gentamicin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
gentamicin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of tenofovir DF by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.
- ibuprofen
tenofovir DF, ibuprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- ibuprofen IV
tenofovir DF, ibuprofen IV. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- indinavir
indinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- indomethacin
tenofovir DF, indomethacin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- istradefylline
istradefylline will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
- ketoprofen
tenofovir DF, ketoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- ketorolac
tenofovir DF, ketorolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- lamivudine
lamivudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- ledipasvir/sofosbuvir
ledipasvir/sofosbuvir will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
ledipasvir/sofosbuvir will increase the level or effect of tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor. - lonafarnib
lonafarnib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- meclofenamate
tenofovir DF, meclofenamate. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- mefenamic acid
tenofovir DF, mefenamic acid. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- meloxicam
tenofovir DF, meloxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- memantine
tenofovir DF increases levels of memantine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- metformin
tenofovir DF increases levels of metformin by decreasing renal clearance. Use Caution/Monitor. Increased risk of lactic acidosis.
- midodrine
tenofovir DF increases levels of midodrine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- mitomycin
mitomycin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
mitomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - morphine
tenofovir DF increases levels of morphine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- nabumetone
tenofovir DF, nabumetone. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- naproxen
tenofovir DF, naproxen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- nelfinavir
nelfinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- neomycin PO
neomycin PO and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
neomycin PO increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - nevirapine
nevirapine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of tenofovir DF by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
- oteseconazole
oteseconazole will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.
- oxaliplatin
oxaliplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- oxaprozin
tenofovir DF, oxaprozin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- pamidronate
pamidronate increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Combination may increase risk of nephrotoxicity.
- pemetrexed
pemetrexed, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
pemetrexed, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. - penicillamine
penicillamine, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
penicillamine increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - pentamidine
pentamidine and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- peramivir
tenofovir DF increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.
- piroxicam
tenofovir DF, piroxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- pramipexole
tenofovir DF increases levels of pramipexole by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- probenecid
probenecid increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- procainamide
tenofovir DF increases levels of procainamide by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- quinidine
tenofovir DF, quinidine. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- regorafenib
regorafenib will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.
- ritonavir
ritonavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - safinamide
safinamide will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.
- saquinavir
saquinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- sarecycline
sarecycline will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- sirolimus
sirolimus, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
sirolimus increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - sitagliptin
tenofovir DF, sitagliptin. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- sofosbuvir
sofosbuvir will increase the level or effect of tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor.
- sofosbuvir/velpatasvir
sofosbuvir/velpatasvir will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for tenofovir-associated adverse reactions in patients receiving EPCLUSA concomitantly with a regimen containing tenofovir DF
- stavudine
stavudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- stiripentol
stiripentol will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
stiripentol will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered. - streptomycin
streptomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
streptomycin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - sulindac
tenofovir DF, sulindac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- tacrolimus
tacrolimus and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.
- tafamidis
tafamidis will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tafamidis meglumine
tafamidis meglumine will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- telavancin
telavancin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
telavancin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - tipranavir
tipranavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tobramycin
tenofovir DF and tobramycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
tobramycin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - tolmetin
tenofovir DF, tolmetin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- trospium chloride
tenofovir DF, trospium chloride. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- tucatinib
tucatinib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- ublituximab
ublituximab decreases effects of tenofovir DF by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
- valacyclovir
valacyclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- valganciclovir
valganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- vancomycin
tenofovir DF and vancomycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- verapamil
tenofovir DF increases levels of verapamil by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- voclosporin
voclosporin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- zidovudine
tenofovir DF and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (2)
- black cohosh
black cohosh, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.
- paromomycin
paromomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.
paromomycin increases levels of tenofovir DF by decreasing elimination. Minor/Significance Unknown.
Adverse Effects
>10%
Asthenia (11%)
Diarrhea (16%)
Nausea (11%)
Pain (12%)
1-10%
Anorexia
Depression
Myalgia
Peripheral neuropathy
Dyspepsia
Rash
Headache
Vomiting
Flatulence
Abdominal pain
Neutropenia
Increased transaminases
Warnings
Black Box Warnings
Hepatitis B Treatment
- Severe acute exacerbations of hepatitis B reported in patients who have discontinued therapy for hepatitis B
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue therapy
- Resumption of therapy for hepatitis B may be warranted
Contraindications
None
Cautions
May cause redistribution/accumulation of body fat that may result in cushingoid appearance
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including TDF, alone or in combination with other antiretrovirals; treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in absence of marked transaminase elevations)
Exacerbation of hepatitis B
- All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating therapy
- Discontinuation of anti-HBV therapy, may be associated with severe acute exacerbations of hepatitis B; patients infected with HBV who discontinue therapy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
- If appropriate, resumption of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis; posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure
Renal toxicity
- Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with therapy
- Prior to initiation and during therapy, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus
- Dosing interval adjustment and close monitoring of renal function recommended in all patients with creatinine clearance below 50 mL/min; no safety or efficacy data are available in patients with renal impairment who received therapy using these dosing guidelines; potential benefit of therapy should be assessed against potential risk of renal toxicity
- Therapy should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs])
- Cases of acute renal failure after initiation of high-dose or multiple NSAIDs reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on TDF
- Some patients required hospitalization and renal replacement therapy; alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction
- Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in patients at risk of renal dysfunction
Patients coinfected with HIV-1 and HBV
- Due to the risk of development of HIV-1 resistance, the drug should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen
- HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy; it is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating therapy
Immune reconstitution syndrome
- The syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy
- During the initial phase of combination antiretroviral treatment, HIV-1 infected patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment
- Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment
Bone loss and mineralization defects
- In HIV-1 infected adults, the drug has been associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover
- Serum parathyroid hormone levels and 1,25 Vitamin D levels have also been reported to be higher in subjects receiving therapy
- The effects of therapy-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults and pediatric subjects 2 years and older are unknown
- The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients, and in particular, the effects of long-duration exposure in younger children is unknown
- Although the effect of supplementation with calcium and vitamin D has not been studied, such supplementation may be beneficial; assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
- If bone abnormalities are suspected, appropriate consultation should be obtained; mineralization defects cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with therapy
- Arthralgia and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy
- Hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving TDF-containing products
Drug interactions overview
- The concomitant use of tenofovir DF with other drugs may result in known or potentially significant drug interactions, some of which may lead to possible clinically significant adverse reactions from greater exposures of concomitant drugs
- Consider potential for drug interactions prior to and during therapy; review concomitant medications during therapy and monitor for adverse reactions associated with concomitant drugs
- Tenofovir DF increases didanosine concentrations; consider dose reduction and close monitoring for didanosine toxicity
- Coadministration with atazanavir decreases atazanavir concentrations; when combined with tenofovir DF, use atazanavir given with ritonavir
- Coadministration with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations; monitor for tenofovir toxicity
Pregnancy & Lactation
Pregnancy
Antiretroviral Pregnancy Registry (APR) monitors pregnancy outcomes in women exposed to tenofovir DF during pregnancy; encourage patients to register at 1-800-258-4263
Human data
- Available prospective reported data from the APR shows no increase in the overall risk of major birth defects with first trimester exposure for tenofovir DF compared with US rate for major birth defects
- Data from 3 controlled clinical trials in 327 pregnant women with chronic HBV infection did not observe an increased risk of adverse pregnancy related outcomes with tenofovir DF use during the third trimester
Animal data
- In animal reproduction studies, no adverse developmental effects were observed when tenofovir DF was administered at doses ≥14 (TDF) and 2.7 (tenofovir) times those of the recommended daily dose
Lactation
Based on published data, tenofovir shown to be present in human breast milk
Unknown if tenofovir DF affects milk production or has effects on the breastfed child
HIV-infected mothers: Breastfeeding in HIV-1 infected mothers is not recommended owing to potential for HIV-1 transmission
HBV-infected mothers: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
In a study of 50 HIV-uninfected, breastfeeding women on a tenofovir-containing regimen initiated between 1 and 24 weeks postpartum (median 13 weeks), drug was undetectable in plasma of most infants after 7 days of treatment in mothers
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
NRTI; analog of adenosine 5'-monophosphate that inhibits HIV-1 reverse transcriptase by competing with AMP as substrate, which results in the inhibition of viral replication
Absorption
Bioavailability: 25% (fasting); increases ~40% with high-fat meal
Peak Plasma Time: 1 hr (fasting); 2 hr (with food)
Distribution
Protein Bound: <7% to serum proteins
Vd: 1.2-1.3 L/kg
Metabolism
Metabolism: not by CYP; converted intracellularly by hydrolysis to tenofovir, then phosphorylated to active tenofovir diphosphate
Elimination
Excretion: Urine (70-80%) via filtration and active secretion, primarily as unchanged tenofovir
Half-life: 17 hr
Administration
Oral Administration
Take with or without food
Administer at least 2 hr before or 1 hr after didanosine
Oral powder
- Measure oral powder only with supplied dosing scoop
- 1 level scoopful = 40 mg
- 300 mg = 7.5 scoops
- Mix oral powder in a container with 2-4 ounces of soft food not requiring chewing (eg, applesauce, baby food, yogurt); the entire mixture should be ingested immediately to avoid a bitter taste
- Do not administer oral powder in a liquid; powder may float on top of the liquid even after stirring
Storage
Tablets and oral powder: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Viread oral - | 250 mg tablet |  | |
| Viread oral - | 150 mg tablet |  | |
| Viread oral - | 40 mg/scoop (40 mg/gram) powder |  | |
| Viread oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  | |
| tenofovir disoproxil fumarate oral - | 300 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tenofovir disoproxil fumarate oral
TENOFOVIR - ORAL
(ten-OF-oh-vir)
COMMON BRAND NAME(S): Viread
WARNING: If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking tenofovir. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop tenofovir. Tell your doctor right away if you develop symptoms of worsening liver problems.
USES: Tenofovir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Tenofovir belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs).Tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.Tenofovir is also used to treat a certain type of liver infection called chronic hepatitis B infection. It helps to decrease the amount of hepatitis B virus in your body by interfering with virus growth.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking tenofovir, and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily.The dosage is based on your medical condition, kidney function, and response to treatment. For children, the dosage is also based on weight.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.
SIDE EFFECTS: Dizziness, diarrhea, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.As your immune system gets stronger with HIV treatment, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety, confusion), signs of kidney problems (such as a change in the amount of urine), unusual thirst.Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness).Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones.Tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking tenofovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis C, cirrhosis), bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis), alcohol use.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Also limit alcohol because it may increase your risk of liver problems and pancreatitis.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you have HIV infection, treatment can lower the risk of passing HIV infection to your baby, and tenofovir may be part of that treatment.This medication passes into breast milk. Consult your doctor before breast-feeding. If you have HIV infection, do not breast-feed because breast milk can transmit HIV.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: adefovir, orlistat, other drugs that may harm the kidneys (including aminoglycosides such as amikacin/gentamicin).Do not take this medication with other products that contain tenofovir.Some other drugs to treat HIV infection (including atazanavir) may also interact with tenofovir. Tenofovir can decrease the effectiveness of atazanavir (by decreasing blood levels). If you are taking atazanavir with this product, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details. Your doctor will adjust your medications and monitor your treatment to reduce the risk of side effects.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as kidney/liver function, urine glucose/protein, viral load, T-cell counts, blood mineral levels, bone density tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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