Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 250mg/vial
injection, ready-to-use solution
- 5mg/mL (250mg/50mL; 500mg/100mL)
Percutaneous Coronary Intervention
Use as anticoagulant in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) syndrome
Has only been studied in patients receiving concomitant aspirin
0.75 mg/kg IV bolus, and then IMMEDIATELY 1.75 mg/kg/hr IV infusion for duration of procedure
Obtain activated clotting time (ACT) 5 min after administering the bolus dose; an additional IV bolus of 0.3 mg/kg should be given if needed
Consider extended duration of infusion following PCI at 1.75 mg/kg/hr for up to 4 hr postprocedure in patients with ST segment elevation MI (STEMI)
Dosage Modifications
Renal impairment
-
Bolus Dose
- No reduction required for any degree of renal impairment
-
IV infusion
- Moderate (CrCl 30-59 mL/min): 1.75 mg/kg/hr
- Severe (CrCl <30 mL/min): 1 mg/kg/hr
- Hemodialysis: 0.25 mg/kg/hr
Hepatic impairment
- No dosage adjustment required
Dosing Considerations
Safety and effectiveness have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI
Heparin-induced Thrombocytopenia (Off-label)
Initial: 0.15-0.2 mg/kg/hr IV; adjust to aPTT 1.5-2.5 times baseline value
Anticoagulation & Risk of HIT (Orphan)
Orphan designation for use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome
Orphan sponsor
- The Medicines Company; 8 Sylvan Way; Parsippany, NJ 07054
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (3)
- defibrotide
defibrotide increases effects of bivalirudin by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.
- mifepristone
mifepristone, bivalirudin. Other (see comment). Contraindicated. Comment: Mifepristone may lead to excessive post abortion bleeding in pts. on anticoagulant therapy.
- prothrombin complex concentrate, human
bivalirudin, prothrombin complex concentrate, human. pharmacodynamic synergism. Contraindicated.
Serious - Use Alternative (63)
- abciximab
bivalirudin, abciximab. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- amobarbital
amobarbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- anagrelide
bivalirudin, anagrelide. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- antithrombin alfa
antithrombin alfa and bivalirudin both increase anticoagulation. Avoid or Use Alternate Drug.
- antithrombin III
antithrombin III and bivalirudin both increase anticoagulation. Avoid or Use Alternate Drug.
- apixaban
bivalirudin and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.
- argatroban
argatroban and bivalirudin both increase anticoagulation. Avoid or Use Alternate Drug.
- azithromycin
azithromycin increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- bazedoxifene/conjugated estrogens
bazedoxifene/conjugated estrogens decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- bemiparin
bemiparin and bivalirudin both increase anticoagulation. Avoid or Use Alternate Drug.
- butabarbital
butabarbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- butalbital
butalbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- caplacizumab
caplacizumab, bivalirudin. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- cefamandole
cefamandole increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- cefazolin
cefazolin increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- cefdinir
cefdinir increases effects of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- cefditoren
cefditoren will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- cefotetan
cefotetan increases effects of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity.
- cefoxitin
cefoxitin will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- cefpodoxime
cefpodoxime will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- ceftriaxone
ceftriaxone will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- cefuroxime
cefuroxime will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- cilostazol
bivalirudin, cilostazol. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- clarithromycin
clarithromycin increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- clopidogrel
bivalirudin, clopidogrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- conjugated estrogens
conjugated estrogens decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- dalteparin
bivalirudin and dalteparin both increase anticoagulation. Avoid or Use Alternate Drug.
- dipyridamole
bivalirudin, dipyridamole. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- edoxaban
edoxaban, bivalirudin. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.
- enoxaparin
bivalirudin and enoxaparin both increase anticoagulation. Avoid or Use Alternate Drug.
- eptifibatide
bivalirudin, eptifibatide. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- erythromycin base
erythromycin base increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- erythromycin lactobionate
erythromycin lactobionate increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- erythromycin stearate
erythromycin stearate increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- estradiol
estradiol decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- estrogens conjugated synthetic
estrogens conjugated synthetic decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- estropipate
estropipate decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- Factor X, human
bivalirudin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.
- fondaparinux
bivalirudin and fondaparinux both increase anticoagulation. Avoid or Use Alternate Drug.
- heparin
bivalirudin and heparin both increase anticoagulation. Avoid or Use Alternate Drug.
- levonorgestrel intrauterine
levonorgestrel intrauterine, bivalirudin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.
- levonorgestrel oral
levonorgestrel oral, bivalirudin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.
- levothyroxine
levothyroxine increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- liothyronine
liothyronine increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- mestranol
mestranol decreases effects of bivalirudin by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.
- pentobarbital
pentobarbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- phenindione
bivalirudin and phenindione both increase anticoagulation. Avoid or Use Alternate Drug.
- phenobarbital
phenobarbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- piperacillin
piperacillin will increase the level or effect of bivalirudin by anticoagulation. Avoid or Use Alternate Drug. cephalosporins may decrease prothrombin activity
- primidone
primidone decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- protamine
bivalirudin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.
- quinine
quinine increases effects of bivalirudin by unknown mechanism. Avoid or Use Alternate Drug.
- roxithromycin
roxithromycin increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- secobarbital
secobarbital decreases effects of bivalirudin by increasing metabolism. Avoid or Use Alternate Drug.
- sulfadiazine
sulfadiazine increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
sulfadiazine increases effects of bivalirudin by plasma protein binding competition. Avoid or Use Alternate Drug. - sulfamethoxazole
sulfamethoxazole increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
sulfamethoxazole increases effects of bivalirudin by plasma protein binding competition. Avoid or Use Alternate Drug. - sulfisoxazole
sulfisoxazole increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
sulfisoxazole increases effects of bivalirudin by plasma protein binding competition. Avoid or Use Alternate Drug. - thyroid desiccated
thyroid desiccated increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- tibolone
tibolone increases effects of bivalirudin by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- ticlopidine
bivalirudin, ticlopidine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- tirofiban
bivalirudin, tirofiban. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.
- warfarin
bivalirudin increases effects of warfarin by anticoagulation. Avoid or Use Alternate Drug. Avoid combined use once INR is established in the desired therapeutic range.
Monitor Closely (121)
- acalabrutinib
acalabrutinib increases effects of bivalirudin by anticoagulation. Use Caution/Monitor. Coadministration of acalabrutinib with antiplatelets or anticoagulants may further increase risk of hemorrhage. Monitor for signs of bleeding and consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending upon the type of surgery and the risk of bleeding.
- aceclofenac
bivalirudin and aceclofenac both increase anticoagulation. Modify Therapy/Monitor Closely.
- acemetacin
bivalirudin and acemetacin both increase anticoagulation. Modify Therapy/Monitor Closely.
- agrimony
bivalirudin and agrimony both increase anticoagulation. Modify Therapy/Monitor Closely.
- alfalfa
bivalirudin and alfalfa both increase anticoagulation. Modify Therapy/Monitor Closely.
- alteplase
bivalirudin and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- American ginseng
bivalirudin and American ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- anamu
bivalirudin and anamu both increase anticoagulation. Use Caution/Monitor.
- aspirin
bivalirudin and aspirin both increase anticoagulation. Modify Therapy/Monitor Closely.
aspirin, bivalirudin. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely. - aspirin rectal
bivalirudin and aspirin rectal both increase anticoagulation. Modify Therapy/Monitor Closely.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate, bivalirudin. Either increases toxicity of the other by anticoagulation. Use Caution/Monitor. The need for simultaneous use of low-dose aspirin and anticoagulant or antiplatelet agents are common for patients with cardiovascular disease; monitor closely.
bivalirudin and aspirin/citric acid/sodium bicarbonate both increase anticoagulation. Modify Therapy/Monitor Closely. - azapropazone
azapropazone increases effects of bivalirudin by plasma protein binding competition. Use Caution/Monitor.
- azathioprine
azathioprine decreases effects of bivalirudin by unknown mechanism. Use Caution/Monitor.
- azficel-T
azficel-T, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- betrixaban
bivalirudin, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.
- budesonide
budesonide, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- capecitabine
capecitabine increases effects of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor.
- carbamazepine
carbamazepine decreases levels of bivalirudin by increasing metabolism. Use Caution/Monitor.
- celecoxib
bivalirudin and celecoxib both increase anticoagulation. Modify Therapy/Monitor Closely.
- chitosan
chitosan increases effects of bivalirudin by Other (see comment). Use Caution/Monitor. Comment: Chitosan can decrease GI absorption of vitamin K, enhancing anticoagulant effects.
- choline magnesium trisalicylate
bivalirudin and choline magnesium trisalicylate both increase anticoagulation. Modify Therapy/Monitor Closely.
- cinnamon
bivalirudin and cinnamon both increase anticoagulation. Modify Therapy/Monitor Closely.
- citalopram
citalopram increases effects of bivalirudin by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.
- collagenase clostridium histolyticum
bivalirudin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).
- conjugated estrogens, vaginal
conjugated estrogens, vaginal decreases effects of bivalirudin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Risk of thromboembolic disorders.
- cordyceps
bivalirudin and cordyceps both increase anticoagulation. Modify Therapy/Monitor Closely.
- cornsilk
cornsilk decreases effects of bivalirudin by pharmacodynamic antagonism. Use Caution/Monitor. Cornsilk contains vitamin K; consume a consistent amount daily.
- cortisone
cortisone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- cyclophosphamide
cyclophosphamide increases effects of bivalirudin by unknown mechanism. Use Caution/Monitor. Additive risk of bleeding may be seen in thrombocytopenic patients receiving antineoplastic agents in combination with anticoagulants such as bivalirudin.
- dabigatran
bivalirudin and dabigatran both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.
- danshen
bivalirudin and danshen both increase anticoagulation. Use Caution/Monitor.
- deferasirox
deferasirox, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- deflazacort
deflazacort, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- devil's claw
bivalirudin and devil's claw both increase anticoagulation. Use Caution/Monitor.
- dexamethasone
dexamethasone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- diclofenac
bivalirudin and diclofenac both increase anticoagulation. Modify Therapy/Monitor Closely.
- diflunisal
bivalirudin and diflunisal both increase anticoagulation. Modify Therapy/Monitor Closely.
diflunisal increases effects of bivalirudin by plasma protein binding competition. Use Caution/Monitor. - dong quai
bivalirudin and dong quai both increase anticoagulation. Modify Therapy/Monitor Closely.
- epoprostenol
bivalirudin and epoprostenol both increase anticoagulation. Modify Therapy/Monitor Closely.
- ethanol
ethanol increases effects of bivalirudin by unknown mechanism. Use Caution/Monitor. Acute EtOH intoxication.
- ethotoin
bivalirudin increases levels of ethotoin by unknown mechanism. Use Caution/Monitor.
ethotoin, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time. - etodolac
bivalirudin and etodolac both increase anticoagulation. Modify Therapy/Monitor Closely.
- fenbufen
bivalirudin and fenbufen both increase anticoagulation. Modify Therapy/Monitor Closely.
- fennel
bivalirudin and fennel both increase anticoagulation. Modify Therapy/Monitor Closely.
- fenoprofen
bivalirudin and fenoprofen both increase anticoagulation. Modify Therapy/Monitor Closely.
- feverfew
bivalirudin and feverfew both increase anticoagulation. Modify Therapy/Monitor Closely.
- fish oil
fish oil, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of bivalirudin 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.
- fludrocortisone
fludrocortisone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- fluorouracil
fluorouracil increases effects of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.
- flurbiprofen
bivalirudin and flurbiprofen both increase anticoagulation. Modify Therapy/Monitor Closely.
- forskolin
bivalirudin and forskolin both increase anticoagulation. Modify Therapy/Monitor Closely.
- fosphenytoin
bivalirudin increases levels of fosphenytoin by unknown mechanism. Use Caution/Monitor.
fosphenytoin, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time. - garlic
bivalirudin and garlic both increase anticoagulation. Modify Therapy/Monitor Closely.
- gemcitabine
gemcitabine increases effects of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of gemcitabine, an additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.
- ginger
bivalirudin and ginger both increase anticoagulation. Modify Therapy/Monitor Closely.
- ginkgo biloba
bivalirudin and ginkgo biloba both increase anticoagulation. Modify Therapy/Monitor Closely.
- glucagon intranasal
glucagon intranasal increases effects of bivalirudin by unknown mechanism. Use Caution/Monitor.
- green tea
green tea, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of bleeding, caution is advised.
- hemin
bivalirudin, hemin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Hemin degradation product (ie, hematin) may produce coagulopathy (eg, thrombocytopenia, platelet degranulation) and cause mild anticoagulant effects.
- horse chestnut seed
bivalirudin and horse chestnut seed both increase anticoagulation. Modify Therapy/Monitor Closely.
- hydrocortisone
hydrocortisone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- ibrutinib
ibrutinib will increase the level or effect of bivalirudin 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
bivalirudin and ibuprofen both increase anticoagulation. Modify Therapy/Monitor Closely.
- ibuprofen IV
bivalirudin and ibuprofen IV both increase anticoagulation. Modify Therapy/Monitor Closely.
- icosapent
icosapent, bivalirudin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- imatinib
imatinib, bivalirudin. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents; patients requiring anticoagulation while on imatinib should receive LMWH or unfractionated heparin instead of warfarin because of multiple interaction mechanisms of imatinib with warfarin.
- indomethacin
bivalirudin and indomethacin both increase anticoagulation. Modify Therapy/Monitor Closely.
- iodine (radioactive)
iodine (radioactive) decreases effects of bivalirudin by pharmacodynamic antagonism. Use Caution/Monitor.
- ketoprofen
bivalirudin and ketoprofen both increase anticoagulation. Modify Therapy/Monitor Closely.
- ketorolac
bivalirudin and ketorolac both increase anticoagulation. Modify Therapy/Monitor Closely.
- ketorolac intranasal
bivalirudin and ketorolac intranasal both increase anticoagulation. Modify Therapy/Monitor Closely.
- lofepramine
lofepramine increases levels of bivalirudin by decreasing metabolism. Use Caution/Monitor.
- lornoxicam
bivalirudin and lornoxicam both increase anticoagulation. Modify Therapy/Monitor Closely.
- meclofenamate
bivalirudin and meclofenamate both increase anticoagulation. Modify Therapy/Monitor Closely.
- mefenamic acid
bivalirudin and mefenamic acid both increase anticoagulation. Modify Therapy/Monitor Closely.
- melatonin
melatonin increases effects of bivalirudin by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.
- meloxicam
bivalirudin and meloxicam both increase anticoagulation. Modify Therapy/Monitor Closely.
- methimazole
methimazole decreases effects of bivalirudin by pharmacodynamic antagonism. Use Caution/Monitor.
- methylprednisolone
methylprednisolone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- mistletoe
bivalirudin increases and mistletoe decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.
- nabumetone
bivalirudin and nabumetone both increase anticoagulation. Modify Therapy/Monitor Closely.
- naproxen
bivalirudin and naproxen both increase anticoagulation. Modify Therapy/Monitor Closely.
- nettle
bivalirudin increases and nettle decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.
- nintedanib
nintedanib increases effects of bivalirudin by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- omega 3 carboxylic acids
omega 3 carboxylic acids, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- omega 3 fatty acids
omega 3 fatty acids, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .
- oxaprozin
bivalirudin and oxaprozin both increase anticoagulation. Modify Therapy/Monitor Closely.
- panax ginseng
bivalirudin and panax ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- parecoxib
bivalirudin and parecoxib both increase anticoagulation. Modify Therapy/Monitor Closely.
- pau d'arco
bivalirudin and pau d'arco both increase anticoagulation. Modify Therapy/Monitor Closely.
- pegaspargase
pegaspargase increases effects of bivalirudin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.
- phenytoin
bivalirudin increases levels of phenytoin by unknown mechanism. Use Caution/Monitor.
phenytoin, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time. - phytoestrogens
bivalirudin and phytoestrogens both increase anticoagulation. Modify Therapy/Monitor Closely.
- piroxicam
bivalirudin and piroxicam both increase anticoagulation. Modify Therapy/Monitor Closely.
- porfimer
bivalirudin decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- prasugrel
bivalirudin, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of hemorrhage.
- prednisolone
prednisolone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- prednisone
prednisone, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- propafenone
propafenone increases effects of bivalirudin by decreasing metabolism. Use Caution/Monitor.
- propylthiouracil
propylthiouracil decreases effects of bivalirudin by pharmacodynamic antagonism. Use Caution/Monitor.
- reishi
bivalirudin and reishi both increase anticoagulation. Modify Therapy/Monitor Closely.
- reteplase
bivalirudin and reteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- rifabutin
rifabutin decreases levels of bivalirudin by increasing metabolism. Use Caution/Monitor.
- rivaroxaban
rivaroxaban, bivalirudin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.
- salicylates (non-asa)
bivalirudin and salicylates (non-asa) both increase anticoagulation. Modify Therapy/Monitor Closely.
- salsalate
bivalirudin and salsalate both increase anticoagulation. Modify Therapy/Monitor Closely.
- saw palmetto
saw palmetto increases toxicity of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor. May increase risk of bleeding.
- Siberian ginseng
bivalirudin and Siberian ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.
- sulfasalazine
bivalirudin and sulfasalazine both increase anticoagulation. Modify Therapy/Monitor Closely.
- sulindac
bivalirudin and sulindac both increase anticoagulation. Modify Therapy/Monitor Closely.
- tenecteplase
bivalirudin and tenecteplase both increase anticoagulation. Modify Therapy/Monitor Closely.
- ticagrelor
ticagrelor, bivalirudin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Increased risk of bleeding during concomitant use of medications that increase potential for bleeding.
- tipranavir
tipranavir increases effects of bivalirudin by pharmacodynamic synergism. Use Caution/Monitor. Tipranavir has mild antiplatelet activity that may incr bleeding risk.
- tolfenamic acid
bivalirudin and tolfenamic acid both increase anticoagulation. Modify Therapy/Monitor Closely.
- tolmetin
bivalirudin and tolmetin both increase anticoagulation. Modify Therapy/Monitor Closely.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.
- triclofos
triclofos increases effects of bivalirudin by unspecified interaction mechanism. Use Caution/Monitor.
- vorapaxar
bivalirudin, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.
- vortioxetine
vortioxetine and bivalirudin both increase anticoagulation. Use Caution/Monitor.
- zanubrutinib
bivalirudin, 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.
Minor (18)
- acetaminophen
acetaminophen increases effects of bivalirudin by unknown mechanism. Minor/Significance Unknown.
- acetaminophen IV
acetaminophen IV increases effects of bivalirudin by unknown mechanism. Minor/Significance Unknown.
- acetaminophen rectal
acetaminophen rectal increases effects of bivalirudin by unknown mechanism. Minor/Significance Unknown.
- alprostadil intracavernous/urethral
alprostadil intracavernous/urethral increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- ceftaroline
ceftaroline increases effects of bivalirudin by Other (see comment). Minor/Significance Unknown. Comment: Cephalosporins with a methylthiotetrazole (MTT) side ring (eg, cefotetan, cefoperazone) are more frequently associated with hypoprothrombinemic activity.
- chlorella
chlorella decreases effects of bivalirudin by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical, due to vitamin K content.
- demeclocycline
demeclocycline increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- dexmethylphenidate
dexmethylphenidate increases effects of bivalirudin by decreasing metabolism. Minor/Significance Unknown.
- doxycycline
doxycycline increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- glyburide
glyburide increases effects of bivalirudin by unspecified interaction mechanism. Minor/Significance Unknown.
- mineral oil
mineral oil decreases levels of bivalirudin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- minocycline
minocycline increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- oxytetracycline
oxytetracycline increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- quinidine
quinidine increases effects of bivalirudin by decreasing metabolism. Minor/Significance Unknown.
- serdexmethylphenidate/dexmethylphenidate
serdexmethylphenidate/dexmethylphenidate increases effects of bivalirudin by decreasing metabolism. Minor/Significance Unknown.
- tetracycline
tetracycline increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.
- verteporfin
bivalirudin decreases effects of verteporfin by pharmacodynamic antagonism. Minor/Significance Unknown.
- vitamin E
vitamin E, bivalirudin. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Vitamin E at RDA does not change INR in pts. on chronic warfarin therapy; megadoses (~10x RDA) may enhance anticoagulant effects in vitamin K deficient pts.
Adverse Effects
>10%
Back pain (42%)
General pain (15%)
Nausea (15%)
Hemorrhage, minor (13.6%)
Headache (12%)
Hypotension (12%)
1-10%
Injection site pain (8%)
Insomnia (7%)
Pelvic pain (6%)
Hypertension (6%)
Anxiety (6%)
Vomiting (6%)
Bradycardia (5%)
Dyspepsia (5%)
Abdominal pain (5%)
Fever (5%)
Nervousness (5%)
Urinary retention (4%)
Hemorrhage, major (2.3%)
≥3g/dL fall in Hgb (1.9%)
TIMI minor bleeding (1.3%)
RBC transfusions (1.3%)
Postmarketing Reports
Pulmonary hemorrhage
Cardiac tamponade
INR increased
Warnings
Contraindications
Active major bleeding
Hypersensitivity
Cautions
Bleeding may occur
Use caution in renal impairment
Not for IM administration
Intended for use with aspirin
Hemorrhage may occur at any site; discontinue bivalirudin if unexplained fall in blood pressure or hematocrit occurs
Monitor for signs and symptoms of bleeding; monitor more frequently for bleeding, patients with disease states associated with increased risk of bleeding
An increased risk of thrombus formation, including fatal outcomes, reported with use of bivalirudin in gamma brachytherapy; if decision made to use bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within catheter or vessels
Bivalirudin affects international normalized ratio (INR); INR measurements made in patients treated with bivalirudin may not be useful for determining appropriate dose of warfarin
Acute stent thrombosis (<4 hr) reported at a greater frequency with bivalirudin compared to heparin treated patients; patients should remain for at least 24 hr in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia
Pregnancy & Lactation
Pregnancy
There are no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Animal data
- Reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times maximum recommended human dose (MRHD) of 15 mg/kg/day based on body surface area (BSA) during organogenesis, respectively, revealed no evidence of fetal harm
Lactation
Not known whether drug is present in human milk; no data are available on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with clinical need for therapy and any potential adverse effects on breastfed child from therapy or from 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
Competitive, direct thrombin inhibitor; thrombin enables fibrinogen conversion to fibrin during the coagulation cascade; Inhibition of fibrinogen conversion to fibrin inhibits thrombus development
Inhibits both free and clot-bound thrombin and thrombin-induced platelet aggregation
Synthetic analog of hirudin
Pharmacokinetics
Half-Life: 25 min (normal renal function); 57 min (severe renal impairment)
Duration: ~ 1 hr after infusion discontinued
Protein Bound: Minimal
Clearance: 60-89 mL/min; Reduced in severe renal impairment
Metabolism: Blood proteases
Excretion: renal
Dialyzable: Yes
Administration
IV Incompatibilities
No incompatibilities observed with glass bottles or polyvinyl chloride bags & administration sets
Y-site: alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine (concentrations 4mg/mL or greater), prochlorperazine, reteplase, streptokinase, vancomycin
IV Compatibilities
Solution: D5W, NS
Y-site: abciximab, alfentanil, ampicillin, ampicillin/sulbactam, azithromycin, ciprofloxacin, diphenhydramine, dobutamine (compatible at concentrations up to 4mg/mL; incompatible at 12.5mg/mL), dopamine, epinephrine, fentanyl, furosemide, heparin, lidocaine, lorazepam, MgSO4, midazolam, morphine SO4, KCl, NaHCO3, TMP-SMX, warfarin, most cephalosporins
IV Preparation
To each 250 mg vial add 5 mL SWI
Gently swirl until all material is dissolved
Dilute each vial in 50 mL of D5W or NS to yield a final concentration of 5 mg/mL
If low-rate infusion is used after initial infusion, a lower concentration bag should be prepared
Inspect for particulate matter and discoloration prior to administration
Do not use preparations containing particulate matter
Reconstituted drug will be a clear to slightly opalescent, colorless to slightly yellow solution
IV Administration
Initial bolus injection followed by continuous infusion
Storage
Store bivalirudin dosage units at 20-25°C (68-77°F); excursions of 15-30°C permitted
Do not freeze reconstituted or diluted bivalirudin
Reconstituted material may be stored at 2-8°C up to 24 hours
Diluted bivalirudin with a concentration between 0.5mg/mL and 5mg/mL is stable at room temperature for up to 24 hours
Discard any unused portion of reconstituted solution remaining in vial
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Angiomax intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  | |
| bivalirudin intravenous - | 250 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
bivalirudin intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your 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: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.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 for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2022 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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