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emtricitabine/ tenofovir alafenamide
Black Box Warnings .
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV/HIV co-infected patients when D/C emtricitabine or tenofovir; monitor hepatic function closely for at least several months in HBV/HIV co-infected patients who D/C emtricitabine/tenofovir alafenamide; initiate anti-HBV tx if needed
Drug Resistance Risk In HIV Pre-Exposure Prophylaxis Use
only prescribe for pre-exposure prophylaxis use in HIV-negative patients; confirm HIV status immediately before tx, then q3mo; drug-resistant HIV variants identified with emtricitabine/tenofovir disoproxil use following undetected acute HIV infection; do not start in patients with acute HIV infection signs/symptoms unless HIV-negative status confirmed
Adult Dosing .
Dosage forms: TAB: 120 mg/15 mg, 200 mg/25 mg
HIV infection
- [200 mg/25 mg PO qd]
HIV pre-exposure prophylaxis
- [200 mg/25 mg PO qd]
- Info: not for patients at risk from receptive vaginal sex; check HIV status before tx start and q3mo or upon diagnosis of other sexually transmitted infections
HIV post-exposure prophylaxis (off-label)
- [200 mg/25 mg PO qd]
- Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
hepatitis B infection, chronic (off-label)
- [200 mg/25 mg PO qd]
renal dosing
- [see below]
- CrCl <30: avoid use
- HD: no adjustment, on dialysis days administer after dialysis; consider supplement if next maintenance dose not due right after dialysis; PD: not defined; Info: not for patients on concomitant protease inhibitors requiring ritonavir or cobicistat boosting
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: TAB: 120 mg/15 mg, 200 mg/25 mg
HIV infection
- [14-24 kg]
- Dose: 120 mg/15 mg PO qd; Info: not for patients on concomitant protease inhibitors requiring ritonavir or cobicistat boosting, other than darunavir/cobicistat
- [25-34 kg]
- Dose: 200 mg/25 mg PO qd; Info: not for patients on concomitant protease inhibitors requiring ritonavir or cobicistat boosting, other than darunavir/cobicistat
- [>35 kg]
- Dose: 200 mg/25 mg PO qd
HIV pre-exposure prophylaxis
- [adolescents, >35 kg]
- Dose: 200 mg/25 mg PO qd; Info: not for patients at risk from receptive vaginal sex; check HIV status before tx start and q3mo or upon diagnosis of other sexually transmitted infections
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [14-24 kg]
- Dose: 120 mg/15 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [>25 kg]
- Dose: 200 mg/25 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
renal dosing
- [see below]
- CrCl <30: avoid use
- HD: no adjustment, on dialysis days administer after dialysis; consider supplement if next maintenance dose not due right after dialysis; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- HIV status, positive or unknown (HIV pre-exposure prophylaxis use)
- CrCl <30
- hepatic impairment, Child-Pugh Class C
- avoid: breastfeeding (HIV infection use in patients with non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (HIV infection use in patients with non-virological suppression postpartum)
- avoid: breastfeeding (HIV infection use in patients with cracked nipple)
- avoid: breastfeeding (HIV infection use in patients with bleeding nipple)
- avoid: breastfeeding (HIV infection use in patients with mastitis)
- avoid: breastfeeding (HBV infection use in patients with cracked nipple)
- avoid: breastfeeding (HBV infection use in patients with bleeding nipple)
- caution: nephrotoxic agent use, concurrent
- caution: nephrotoxic agent use, recent
- caution: acute HIV infection, suspected (HIV pre-exposure prophylaxis use)
- caution: renal disease risk
- caution: hepatic disease risk
- caution: HIV infection and HBV infection, concurrent
- caution: nucleoside tx, long-term
- caution: obesity
Drug Interactions .
Overview
emtricitabine
NRTI
- intracellular phosphorylation inhibitor
- affected by altered fat absorption
- interferes w/ gene therapy
tenofovir alafenamide
NRTI
- BCRP substrate
- P-gp substrate
- intracellular phosphorylation inhibitor
- affected by altered fat absorption
- interferes w/ gene therapy
- nephrotoxicity
- tenofovir alafenamide (prodrug) converted to tenofovir
Contraindicated
- carbamazepine
- cidofovir
- fosphenytoin
- phenobarbital
- phenytoin
- rifampin
- St. John's wort
Avoid/Use Alternative
- adefovir dipivoxil
- aldesleukin
- amikacin
- amikacin inhaled
- apalutamide
- atazanavir
- atidarsagene autotemcel
- betibeglogene autotemcel
- bumetanide
- cladribine oral
- clofarabine
- cobicistat
- danshen
- dicloxacillin
- efavirenz
- elivaldogene autotemcel
- eslicarbazepine acetate
- foscarnet
- ganciclovir
- gentamicin
- lorlatinib
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- mannitol
- methotrexate
- oxaliplatin
- oxcarbazepine
- pentamidine
- polymyxin B
- primidone
- rifabutin
- rifapentine
- streptomycin
- streptozocin
- tenofovir disoproxil
- tipranavir
- tobramycin
- tobramycin inhaled
- turmeric
- valganciclovir
Monitor/Modify Tx
- abrocitinib
- acalabrutinib
- acyclovir
- adagrasib
- aficamten
- alectinib
- aliskiren
- amiloride
- amiodarone
- amphotericin
- anthrax immune globulin
- asciminib
- aspirin
- auranofin
- axitinib
- azilsartan medoxomil
- azithromycin
- balsalazide
- belumosudil
- benazepril
- berotralstat
- bevacizumab
- bisoprolol
- bleomycin
- botulism immune globulin
- brigatinib
- cabozantinib
- canagliflozin
- candesartan cilexetil
- cannabidiol
- capecitabine
- capmatinib
- captopril
- carboplatin
- carfilzomib
- carvedilol
- celecoxib
- chlorothiazide
- chlorthalidone
- cimetidine
- cisplatin
- clarithromycin
- clindamycin
- colistimethate
- copper histidinate
- creatine
- cyclophosphamide
- cyclosporine
- cytomegalovirus immune globulin
- danicopan
- daridorexant
- darolutamide
- deferasirox
- deferoxamine
- diclofenac
- diclofenac topical
- diflunisal
- diltiazem
- diosmin
- dronedarone
- elacestrant
- elagolix
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- eltrombopag
- eluxadoline
- enalapril
- enalaprilat
- enasidenib
- encorafenib
- entrectinib
- enzalutamide
- erdafitinib
- erythromycin
- ethacrynic acid
- etodolac
- etuvetidigene autotemcel
- everolimus
- febuxostat
- felodipine
- fenoprofen
- flibanserin
- flucytosine
- flurbiprofen
- fluvoxamine
- fosinopril
- fostamatinib
- fostemsavir
- furosemide
- gilteritinib
- ginkgo
- grazoprevir
- hydrochlorothiazide
- hydroxocobalamin IV
- ibrutinib
- ibuprofen
- ibuprofen lysine
- ifosfamide
- imatinib
- imlunestrant
- immune globulin
- indapamide
- indomethacin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irbesartan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- ketoprofen
- ketorolac
- lapatinib
- lazertinib
- ledipasvir
- leflunomide
- leniolisib
- lenvatinib
- levacetylleucine
- levoketoconazole
- lifileucel
- lisinopril
- lithium
- lomitapide
- lomustine
- lonafarnib
- losartan
- lutetium Lu 177 vipivotide tetraxetan
- magnesium citrate
- magnesium salicylate
- maribavir
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- mesalamine
- mesalamine rectal
- metolazone
- midostaurin
- mifepristone
- milk thistle
- mirabegron
- mitapivat
- mitomycin
- moexipril
- momelotinib
- nabumetone
- naproxen
- nefazodone
- nelfinavir
- neomycin
- neratinib
- nifedipine
- nusinersen
- olmesartan medoxomil
- olsalazine
- orlistat
- osimertinib
- oteseconazole
- oxaprozin
- pacritinib
- pamidronate
- paromomycin
- paroxetine
- pazopanib
- pemetrexed
- penicillamine
- pentostatin
- perindopril
- piroxicam
- pirtobrutinib
- plazomicin
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- posaconazole
- pretomanid
- primaquine
- propafenone
- quercetin
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ramipril
- ramucirumab
- ranolazine
- regorafenib
- remibrutinib
- resmetirom
- Rho(D) immune globulin
- rilzabrutinib
- ritonavir
- rituximab
- rolapitant
- ropeginterferon alfa-2b
- rucaparib
- salsalate
- sarecycline
- selpercatinib
- sevabertinib
- sirolimus
- sitagliptin
- sorafenib
- sotagliflozin
- sotorasib
- sparsentan
- spironolactone
- stiripentol
- sulfate bowel prep
- sulindac
- sunitinib
- sunvozertinib
- suvorexant
- tacrolimus
- tafamidis
- tedizolid
- telavancin
- telmisartan
- temsirolimus
- tepotinib
- teriflunomide
- tezacaftor/ivacaftor
- ticagrelor
- tiopronin
- tivozanib
- tolmetin
- tolvaptan
- torsemide
- trandolapril
- trazodone
- triamterene
- trimethoprim
- trofinetide
- tucatinib
- uridine triacetate
- vaccinia immune globulin
- vadadustat
- valacyclovir
- valbenazine
- valsartan
- vancomycin
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- vemurafenib
- venetoclax
- verapamil
- vimseltinib
- voclosporin
- willow bark
- xanomeline
- ziv-aflibercept
- zoledronic acid
- zongertinib
- zonisamide
Caution Advised
- meropenem
- vaborbactam
Adverse Reactions .
Serious Reactions
- lactic acidosis
- hepatomegaly with steatosis
- hepatotoxicity
- HBV exacerbation, post-tx (HBV co-infected patients)
- pancreatitis
- nephrotoxicity
- neutropenia
- immune reconstitution syndrome
- autoimmune disorder
- angioedema
Common Reactions
- diarrhea
- nausea
- vomiting
- fatigue
- asthenia
- headache
- dizziness
- depression
- insomnia
- abnormal dreams
- rash
- hypercholesterolemia
- CK elevated
- bone density loss
- hyperamylasemia
- anemia (peds patients)
- arthralgia
- myalgia
- cough incr.
- dyspepsia
- abdominal pain
- paresthesia
- peripheral neuropathy
- palmar-plantar hyperpigmentation
- hypertriglyceridemia
- LFTs elevated
- neutropenia
- hematuria
- hyperglycemia
- rhinitis
- glycosuria
- flatulence
- weight gain
Safety/Monitoring .
Monitoring Parameters
HIV Infection: hepatitis B serology including HBsAg at baseline; 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 co-infection, continue for several mo after D/C; phosphorus if chronic kidney disease
HIV Pre-exposure Prophylaxis: hepatitis B serology including HBsAg at baseline; CrCl at baseline, then q6mo in patients >50 yo or with CrCl <90 mL/min at baseline, otherwise q12mo; LFTs for several mo after D/C if HBV co-infection; lipid profile, weight q12mo
HBV Infection: HIV screening at baseline; 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 for several mo after D/C; phosphorus if chronic kidney disease
Pregnancy/Lactation .
Pregnancy
Clinical Summary
emtricitabine: benefits outweigh risks during pregnancy; no known risk of fetal harm based on limited human data and animal data at 60x and 120x recommended human dose
tenofovir alafenamide: may use during pregnancy; no known risk of fetal harm based on limited human data and animal data at >51x recommended human dose; possible risk of low birth wt based on conflicting animal data with tenofovir disoproxil
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
HIV Pre-Exposure Prophylaxis Use: avoid use in patients at risk of HIV transmission from receptive vaginal sex, otherwise may use while breastfeeding; no known risk of infant harm with emtricitabine based on human data; inadequate human data available with tenofovir alafenamide, though possible risk of infant diarrhea based on limited human data with tenofovir disoproxil; no human data available to assess effects on milk production
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 with 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 with emtricitabine based on human data; inadequate human data available with tenofovir alafenamide, though possible risk of infant diarrhea based on limited human data with tenofovir disoproxil; no human data available to assess effects on milk production
HBV Infection Use: avoid breastfeeding if nipples cracked or bleeding, otherwise weigh risk/benefit while breastfeeding; no known risk of infant harm with emtricitabine based on human data; inadequate human data available with tenofovir alafenamide, though possible risk of infant diarrhea based on limited human data with tenofovir disoproxil; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for emtricitabine: oxidation; CYP450: none; UGT: substrate (enzymes not defined); for tenofovir disoproxil: intracellular; CYP450: minimal; 3A substrate
Excretion: for emtricitabine: urine 70%, feces 14%; Half-life: 10h; for tenofovir alafenamide: feces 31.7%; urine <1%; Half-life: 30min
Subclass: Hepatitis B (HBV) ; HIV: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Mechanism of Action
for emtricitabine: inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination; for tenofovir alefanamide: prodrug converted to tenofovir, which inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
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