Dosing & Uses
Dosage Forms & Strengths
capsule
- 40mg
- 80mg
Venous Thromboembolism Prevention
Patients hospitalized for acute medical illness at risk for thromboembolic complications
Moderate or severe restricted mobility and other risk factors for VTE: 160 mg PO once initially, THEN 80 mg PO qDay
Recommended duration of treatment: 35-42 days
Dosage Modifications
Coadministration with P-gp inhibitors
- Initial single dose of 80 mg, then 40 mg PO qDay x35-42 days
- Patients taking P-gp inhibitor who also have severe renal impairment: Not recommended
Renal impairment
- Mild-to-moderate (CrCl >30 mL/min): No dose adjustment needed
- Severe (CrCl ≥15 to <30 mL/min): Initial single dose of 80 mg, then 40 mg PO qDay x35-42 days
Hepatic impairment
- Mild: No dose adjustment required
- Moderate-to-severe: Avoid use; these patients may have intrinsic coagulation abnormalities
Dosing Considerations
Limitations of use
- Safety and efficacy not established for patients with prosthetic heart valves (not studied)
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- apixaban
apixaban, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.
- rivaroxaban
rivaroxaban, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.
Serious - Use Alternative (6)
- edoxaban
edoxaban, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.
- erdafitinib
erdafitinib will increase the level or effect of betrixaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- fondaparinux
fondaparinux, betrixaban. Either increases levels of the other by anticoagulation. Contraindicated. Therapeutic duplication; may use temporarily when switching anticoagulants.
- lasmiditan
lasmiditan increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- sotorasib
sotorasib will decrease the level or effect of betrixaban 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 betrixaban 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 (133)
- abciximab
abciximab, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- abiraterone
abiraterone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- afatinib
afatinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- amiodarone
amiodarone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- anagrelide
anagrelide, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- antithrombin alfa
antithrombin alfa, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- antithrombin III
antithrombin III, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- argatroban
argatroban, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- aspirin
aspirin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- aspirin rectal
aspirin rectal, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- atorvastatin
atorvastatin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- azithromycin
azithromycin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- berotralstat
berotralstat will increase the level or effect of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bivalirudin
bivalirudin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- bosutinib
bosutinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- canagliflozin
canagliflozin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- caplacizumab
caplacizumab, betrixaban. Either increases effects of the other by anticoagulation. Use Caution/Monitor.
- carvedilol
carvedilol increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- celecoxib
celecoxib, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- choline magnesium trisalicylate
choline magnesium trisalicylate, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- cilostazol
cilostazol, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- citalopram
citalopram, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- clarithromycin
clarithromycin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- clopidogrel
clopidogrel, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- cobicistat
cobicistat increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- crizotinib
crizotinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- cyclosporine
cyclosporine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- dabigatran
dabigatran, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- dalteparin
dalteparin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- darunavir
darunavir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- desirudin
desirudin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- diclofenac
diclofenac, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- diflunisal
diflunisal, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- dipyridamole
dipyridamole increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
dipyridamole, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. - dronedarone
dronedarone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- elagolix
elagolix will increase the level or effect of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- eliglustat
eliglustat increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- enoxaparin
enoxaparin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- eptifibatide
eptifibatide, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- erythromycin base
erythromycin base increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- erythromycin lactobionate
erythromycin lactobionate increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- erythromycin stearate
erythromycin stearate increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- escitalopram
escitalopram, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- etodolac
etodolac, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- etravirine
etravirine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- everolimus
everolimus increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- fenoprofen
fenoprofen, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- fish oil
fish oil, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of betrixaban by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- flibanserin
flibanserin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- fluoxetine
fluoxetine increases effects of betrixaban by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- flurbiprofen
flurbiprofen, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- fluvoxamine
fluvoxamine, betrixaban. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor.
- fostamatinib
fostamatinib will increase the level or effect of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- garlic
garlic, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- grapefruit
grapefruit increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- heparin
heparin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- ibrutinib
ibrutinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
ibrutinib will increase the level or effect of betrixaban by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding. - ibuprofen
ibuprofen, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- ibuprofen IV
ibuprofen IV, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- indomethacin
indomethacin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- isavuconazonium sulfate
isavuconazonium sulfate increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- istradefylline
istradefylline will increase the level or effect of betrixaban 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.
- itraconazole
itraconazole increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ivacaftor
ivacaftor increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.
- ketoconazole
ketoconazole increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ketoprofen
ketoprofen, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- ketorolac
ketorolac, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- ketorolac intranasal
ketorolac intranasal, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- lapatinib
lapatinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ledipasvir/sofosbuvir
ledipasvir/sofosbuvir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- lomitapide
lomitapide increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- lonafarnib
lonafarnib will increase the level or effect of betrixaban 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.
- lopinavir
lopinavir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- meclofenamate
meclofenamate, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- mefenamic acid
mefenamic acid, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- mefloquine
mefloquine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- meloxicam
meloxicam, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- nabumetone
nabumetone, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- naproxen
naproxen, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- nelfinavir
nelfinavir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- netupitant/palonosetron
netupitant/palonosetron increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- nicardipine
nicardipine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- nifedipine
nifedipine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- nilotinib
nilotinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ombitasvir/paritaprevir/ritonavir & dasabuvir
ombitasvir/paritaprevir/ritonavir & dasabuvir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- omega 3 carboxylic acids
omega 3 carboxylic acids, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- omega 3 fatty acids
omega 3 fatty acids, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- oxaprozin
oxaprozin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- paliperidone
paliperidone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- paroxetine
paroxetine, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- pentostatin
pentostatin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- piroxicam
piroxicam, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- ponatinib
ponatinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- posaconazole
posaconazole increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- prasugrel
prasugrel, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- progesterone micronized
progesterone micronized increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- progesterone, natural
progesterone, natural increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- propafenone
propafenone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- propranolol
propranolol increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- protein C concentrate
protein C concentrate, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- quinidine
quinidine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- quinine
quinine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ranolazine
ranolazine increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ritonavir
ritonavir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- salsalate
salsalate, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- sapropterin
sapropterin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- saquinavir
saquinavir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- sarecycline
sarecycline will increase the level or effect of betrixaban 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.
- sertraline
sertraline, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- sofosbuvir/velpatasvir
sofosbuvir/velpatasvir increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- stiripentol
stiripentol will increase the level or effect of betrixaban 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.
- sulindac
sulindac, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- sunitinib
sunitinib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- suvorexant
suvorexant increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- tacrolimus
tacrolimus increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ticagrelor
ticagrelor increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- ticlopidine
ticlopidine, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- tirofiban
tirofiban, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- tolmetin
tolmetin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- tucatinib
tucatinib will increase the level or effect of betrixaban 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.
- ulipristal
ulipristal increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- vandetanib
vandetanib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- vemurafenib
vemurafenib increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- venetoclax
venetoclax increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- verapamil
verapamil increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- vilazodone
vilazodone, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- vitamin E
vitamin E, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- vortioxetine
vortioxetine, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.
- warfarin
warfarin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- zanubrutinib
betrixaban, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.
- zonisamide
zonisamide increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
Minor (0)
Adverse Effects
1-10%
Clinically relevant nonmajor bleeding (2.45%)
Epistaxis (2%)
Hematuria (2%)
<1%
Bleeding
- Major bleeding (0.67%)
- GI bleeding (0.51%)
- Intracranial hemorrhage (0.05%)
- Fatal bleeding (0.03%)
Postmarketing Reports
Increased risk of thrombosis in patients with triple-positive antiphospholipid syndrome
Warnings
Black Box Warnings
Spinal/epidural hematoma
- Epidural or spinal hematomas may occur in patients who are receiving neuraxial anesthesia or undergoing spinal puncture
- These hematomas may result in long-term or permanent paralysis
- Monitor patients frequently for signs and symptoms of neurological impairment (eg, numbness or weakness of legs, bowel, or bladder); if neurological compromise is noted, urgent treatment is necessary
- Consider the benefits and risks before neuraxial intervention in patients who are anticoagulated or to be anticoagulated
Management
- Do not remove an epidural catheter earlier than 72 hr after the last administration of betrixaban
- Do not administer the next betrixaban dose earlier than 5 hr after catheter removal
- If traumatic puncture occurs, delay administering betrixaban for 72 hr
Factors that can increase the risk include
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
- History of traumatic or repeated epidural or spinal punctures
- History of spinal deformity or spinal surgery
- Optimal timing between the administration of drug and neuraxial procedures is not known
Contraindications
Active pathological bleeding
Severe hypersensitivity
Cautions
Increases bleeding risk and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; there is no established way to reverse betrixaban’s anticoagulant effect, which can persist for at least 72 hr after the last dose; protamine, vitamin K, and tranexamic acid are not expected to reverse betrixaban anticoagulant activity
Not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2- glycoprotein I antibodies]), treatment with direct-acting oral anticoagulants has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy
Risk of paralysis with neuraxial anesthesia (see Black Box Warnings)
Increased bleeding risk with severe renal impairment (see Dosage Modifications)
Drug interaction overview
- P-gp substrate
- Reduce betrixaban dose if coadministration with P-gp inhibitors, owing to increased bleeding risk; avoid coadministration in patients with severe renal impairment receiving concomitant P-gp inhibitors
- Avoid coadministration with P-gp inducers owing to potential for decreased systemic exposure and pharmacodynamic effects of betrixaban
- Coadministration with drugs affecting hemostasis increases bleeding risk; examples include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs
Pregnancy
Pregnancy
No data exist with use in pregnant women, but treatment is likely to increase risk of hemorrhage during pregnancy and delivery
Use during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus
Animal studies
- Although betrixaban has not been associated with adverse developmental fetal outcomes in animals, maternal toxicity (ie, hemorrhage) was identified in these studies
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding 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
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
Oral factor Xa (FXa) inhibitor that selectively blocks the active site of FXa and does not require a cofactor (eg, antithrombin III) for activity; inhibits free FXa and prothrombinase activity
By directly inhibiting FXa, betrixaban decreases thrombin generation
Has no direct effect on platelet aggregation
Blood coagulation cascade is dependent upon the activation of factor X to FXa via the intrinsic and extrinsic pathways, which play a central role in the blood coagulation cascade
Absorption
Bioavailability: 34%
Peak plasma time: 3-4 hr
Distribution
Protein bound: 60%
Vd: 32 L/kg
Metabolism
Unchanged betrixaban is the predominant component found in human plasma
Two inactive major metabolites formed by CYP-independent hydrolysis comprise the other components in plasma, accounting for 15-18% of the circulating drug-related material
Elimination
Half-life: 19-27 hr
Excretion: 85% feces; 11% urine
Administration
Oral Administration
Take with food at approximately the same time each day
Missed dose: Take as soon as possible on the same day; do not double dosage to make up for a missed dose
Storage
Store at room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
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Formulary
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