Bivalirudin

Bivalirudin is a prescription medication used to treat heparin-induced thrombocytopenia (HIT) and heparin- induced thrombocytopenia and thrombosis (HITT).

• Bivalirudin is available under the following different brand names: Angiomax, Angiomax RTU.

Adult dosage

Injection, powder for reconstitution

• 250mg/vial

Injection, ready-to-use solution

• 5mg/mL (250mg/50mL; 500mg/100mL)

Percutaneous Coronary Intervention

Adult dosage

• 0.75 mg/kg IV bolus, and then IMMEDIATELY 1.75 mg/kg/hour IV infusion for duration of procedure
• Obtain activated clotting time (ACT) 5 minutes 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/hour for up to 4 hours post procedure in patients with ST segment elevation MI (STEMI)

Dosage Considerations – Should be Given as Follows: 

See "Dosages."

Common side effects of Bivalirudin include:

• bleeding

Serious side effects of Bivalirudin include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• lightheadedness, 
• easy bruising, 
• unusual bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding), 
• bloody or tarry stools, 
• coughing up blood, 
• vomit that looks like coffee grounds, 
• sudden numbness or weakness, 
• problems with vision or speech, 
• urine that looks red, pink, or brown, 
• swelling or redness in an arm or leg,
• bleeding from wounds or needle injections, and
• any bleeding that will not stop 

Rare side effects of Bivalirudin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Bivalirudin has severe interactions with the following drugs:
  • defibrotide
  • mifepristone
  • prothrombin complex concentrate, human
• Bivalirudin has serious interactions with at least 62 other drugs.
• Bivalirudin has moderate interactions with at least 122 other drugs.
• Bivalirudin has minor interactions with at least 17 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Active major bleeding
• Hypersensitivity 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bivalirudin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bivalirudin?”

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 (less than 4 hours) reported at a greater frequency with bivalirudin compared to heparin treated patients; patients should remain for at least 24 hours 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 and Lactation

• There is no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
• 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.