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Vemlidy
tenofovir alafenamide
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: 25 mg
hepatitis B infection, chronic
- [25 mg PO qd]
- Info: for patients w/ compensated liver disease; give w/ food
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [25 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant patients w/ HBV DNA >200,000; 1st-line agent; give w/ food; D/C between birth to 3mo postpartum
HIV infection (off-label)
- [25 mg PO qd]
- Info: give w/ food
HIV post-exposure prophylaxis (off-label)
- [25 mg PO qd]
- Info: part of multi-drug regimen; give w/ food; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
renal dosing
- [see below]
- CrCl <15: avoid use
- HD: no adjustment, on dialysis days admin. after dialysis; consider supplement if next maintenance dose not due right after dialysis; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: avoid use
Peds Dosing .
- Dosage forms: TAB: 25 mg
hepatitis B infection, chronic
- [6 yo and older, >25 kg]
- Dose: 25 mg PO qd; Info: for patients w/ compensated liver disease; give w/ food
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [25 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant patients w/ HBV DNA >200,000; 1st-line agent; give w/ food; D/C between birth to 3mo postpartum
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [25 mg PO qd]
- Info: part of multi-drug regimen; give w/ food; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- CrCl <15 (patients not on dialysis)
- hepatic impairment, Child-Pugh Class B-C
- 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)
- caution: nephrotoxic agent use, concurrent
- caution: nephrotoxic agent use, recent
- 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
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
- 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
- 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
- everolimus
- febuxostat
- felodipine
- fenoprofen
- flibanserin
- flucytosine
- flurbiprofen
- fluvoxamine
- fosinopril
- fostamatinib
- fostemsavir
- furosemide
- futibatinib
- gilteritinib
- ginkgo
- grazoprevir
- hydrochlorothiazide
- hydroxocobalamin IV
- ibrutinib
- ibuprofen
- ibuprofen lysine
- ifosfamide
- imatinib
- imlunestrant
- immune globulin
- indapamide
- indomethacin
- iohexol
- iomeprol
- iopamidol
- irbesartan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- ketoprofen
- ketorolac
- lapatinib
- lasmiditan
- lazertinib
- ledipasvir
- leflunomide
- leniolisib
- lenvatinib
- levacetylleucine
- levoketoconazole
- lifileucel
- lisinopril
- lithium
- lomitapide
- 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
- 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
- sirolimus
- sitagliptin
- sorafenib
- sotagliflozin
- sotorasib
- sparsentan
- spironolactone
- stiripentol
- sulfate bowel prep
- sulindac
- sunitinib
- sunvozertinib
- suvorexant
- tacrolimus
- tafamidis
- tedizolid phosphate
- 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 w/ steatosis
- hepatotoxicity
- HBV exacerbation, post-tx
- nephrotoxicity
- pancreatitis
- angioedema
Common Reactions
- headache
- ALT or AST elevated
- abdominal pain
- fatigue
- cough
- nausea
- back pain
- arthralgia
- diarrhea
- dyspepsia
- glycosuria
- hypercholesterolemia
- CK elevated
- hyperamylasemia
- bone density loss
- vomiting
- rash
- flatulence
- weight gain
Safety/Monitoring .
Monitoring Parameters
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
Pregnancy/Lactation .
Pregnancy
Clinical Summary
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 w/ drug of choice tenofovir disoproxil
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
HBV Infection or Perinatal Prophylaxis Use: avoid breastfeeding if nipples cracked or bleeding, otherwise weigh risk/benefit while breastfeeding; inadequate human data available, though possible risk of infant diarrhea based on limited human data w/ 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 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; inadequate human data available, though possible risk of infant diarrhea based on limited human data w/ tenofovir disoproxil; no human data available to assess effects on milk production
Pharmacology .
Metabolism: intracellular; CYP450: minimal; 3A substrate; Info: prodrug converted to tenofovir
Excretion: feces 31.7%; urine <1%; Half-life: 30min
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 (nucleotide reverse transcriptase inhibitor)
Formulary .
No Formulary Selected
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