Thursday, September 29, 2016

bivalirudin


Generic Name: bivalirudin (bye VAL i roo din)

Brand Names: Angiomax


What is bivalirudin?

Bivalirudin keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.


Bivalirudin is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty (to open blocked arteries).


Bivalirudin may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about bivalirudin?


Do not use this medication if you are allergic to bivalirudin, or if you have any major bleeding from a surgery, injury, or other medical trauma. Bivalirudin is not expected to be harmful to an unborn baby. However, aspirin is usually given with bivalirudin, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with bivalirudin and aspirin.


Before using bivalirudin, tell your doctor if you are allergic to any drugs, or if you have heart disease, kidney disease, or a bleeding or blood clotting disorder such as hemophilia.


Tell your doctor if you are using or receiving blood thinners or any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).

Because bivalirudin keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.


What should I discuss with my health care provider before taking bivalirudin?


Do not use this medication if you are allergic to bivalirudin, or if you have any major bleeding from a surgery, injury, or other medical trauma.

Before using bivalirudin, tell your doctor if you are allergic to any drugs, or if you have:



  • heart disease;




  • kidney disease; or




  • a bleeding or blood clotting disorder (such as hemophilia).



If you have any of these conditions, you may not be able to use bivalirudin, or you may need dosage adjustments or special tests during treatment.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. However, aspirin is usually given with bivalirudin, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with bivalirudin and aspirin.


It is not known whether bivalirudin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take bivalirudin?


Bivalirudin is given as an injection through a needle placed into a vein. You will receive this injection during your angioplasty procedure in a clinic or hospital setting. The medicine must be given throughout the entire procedure.


Bivalirudin is usually given together with aspirin.


Because bivalirudin keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.


See also: Bivalirudin dosage (in more detail)

What happens if I miss a dose?


Since bivalirudin is usually given in a hospital or clinic setting as needed, it is not likely that you will miss a dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a bivalirudin overdose are not known.


What should I avoid while taking bivalirudin?


Bivalirudin lowers blood cells that help your blood clot. This can make it easier for you to bruise or bleed from an injury or minor cut. Avoid activities that increase your risk of a bruising or bleeding injury. Use extra caution to avoid cuts when brushing your teeth or shaving.


Avoid drinking alcohol while taking bivaluridin. Alcohol may increase your risk of bleeding in your stomach or intestines.

Bivalirudin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • pain or swelling in one or both legs;




  • any bleeding that will not stop;




  • black, bloody, or tarry stools;




  • coughing up blood or vomit that looks like coffee grounds;




  • slow heart rate;




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);




  • decreased blood pressure (feeling light-headed or fainting); or




  • urinating less than usual or not at all.



Less serious side effects are more likely to occur, such as:



  • pain in your back or pelvis;




  • nausea, vomiting, stomach pain or upset;




  • feeling restless or nervous;




  • headache;




  • fever;




  • sleep problems (insomnia);




  • pain, bleeding, or irritation where the injection was given.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Bivalirudin Dosing Information


Usual Adult Dose for Angina Pectoris:

Initial: 0.75 mg/kg administered as an intravenous bolus dose, followed by 1.75 mg/kg/hour for the duration of the PCI procedure.

Five minutes after the bolus dose, an ACT should be performed and an additional bolus of 0.3 mg/kg should be given if needed. Administration of a glycoprotein IIb/IIIa inhibitor should be considered in the event that any of the following conditions are present: decreased TIMI flow (0 to 2) or slow reflow; dissection with decreased flow; new or suspected thrombus; persistent residual stenosis; distal embolization; unplanned stent; suboptimal stenting; side branch closure; abrupt closure; clinical instability; and prolonged ischemia.

The recommended dose of bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus dose of 0.75 mg/kg, followed by a continuous infusion at a rate of 1.75 mg/kg/hour for the duration of the procedure.

Continuation of the infusion for up to 4 hours post procedure is optional. After 4 hours, an additional IV infusion may be initiated at a rate of 0.2 mg/kg/hour for up to 20 hours if needed.

Bivalirudin is intended for use with aspirin (300 mg to 325 mg daily), and has been studied only in patients receiving concomitant aspirin.

Usual Adult Dose for Percutaneous Coronary Intervention:

Initial: 0.75 mg/kg administered as an intravenous bolus dose, followed by 1.75 mg/kg/hour for the duration of the PCI procedure.

Five minutes after the bolus dose, an ACT should be performed and an additional bolus of 0.3 mg/kg should be given if needed. Administration of a glycoprotein IIb/IIIa inhibitor should be considered in the event that any of the following conditions are present: decreased TIMI flow (0 to 2) or slow reflow; dissection with decreased flow; new or suspected thrombus; persistent residual stenosis; distal embolization; unplanned stent; suboptimal stenting; side branch closure; abrupt closure; clinical instability; and prolonged ischemia.

The recommended dose of bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus dose of 0.75 mg/kg, followed by a continuous infusion at a rate of 1.75 mg/kg/hour for the duration of the procedure.

Continuation of the infusion for up to 4 hours post procedure is optional. After 4 hours, an additional IV infusion may be initiated at a rate of 0.2 mg/kg/hour for up to 20 hours if needed.

Bivalirudin is intended for use with aspirin (300 mg to 325 mg daily), and has been studied only in patients receiving concomitant aspirin.


What other drugs will affect bivalirudin?


Before receiving bivalirudin, tell your doctor if you are using or receiving any of the following drugs:



  • a blood thinner such as warfarin (Coumadin), heparin, ardeparin (Normiflo), dalteparin (Fragmin), danaparoid (Orgaran), enoxaparin (Lovenox), or tinzaparin (Innohep); or




  • any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).



If you are using any of these drugs, you may not be able to use bivalirudin, or you may need dosage adjustments or special tests during treatment.


There may be other drugs not listed that can affect bivalirudin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More bivalirudin resources


  • Bivalirudin Side Effects (in more detail)
  • Bivalirudin Dosage
  • Bivalirudin Use in Pregnancy & Breastfeeding
  • Bivalirudin Drug Interactions
  • Bivalirudin Support Group
  • 0 Reviews for Bivalirudin - Add your own review/rating


  • bivalirudin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Bivalirudin Professional Patient Advice (Wolters Kluwer)

  • Bivalirudin Monograph (AHFS DI)

  • Bivalirudin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Angiomax Prescribing Information (FDA)



Compare bivalirudin with other medications


  • Angina
  • Percutaneous Coronary Intervention


Where can I get more information?


  • Your pharmacist has information about bivalirudin written for health professionals that you may read.

See also: bivalirudin side effects (in more detail)


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