Pricing
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All price changes →Indications & Uses
Biva is indicated for:
Pharmacology
Bivalirudin works as a direct thrombin inhibitor, binding specifically to both the catalytic site and the anion-binding exosite of thrombin, whether the thrombin is circulating freely or already bound within a clot. Thrombin is a serine proteinase that sits at the center of the clotting process: it cleaves fibrinogen into fibrin monomers and activates Factor XIII to Factor XIIIa, which lets fibrin build a covalently cross-linked framework that stabilizes the thrombus. Thrombin also activates Factors V and VIII, which drives further thrombin generation, and it activates platelets, triggering aggregation and granule release. Bivalirudin's binding to thrombin is reversible, since thrombin gradually cleaves the bivalirudin-Arg3-Pro4 bond, allowing thrombin's active site functions to recover over time.
In laboratory (in vitro) studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by substances released during the platelet release reaction, and prolonged the activated partial thromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical significance of these findings is not yet known.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Bivalirudin dosage for adults during and after PCI/PTCA
For PCI/PTCA, the adult dose is an IV bolus of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI procedure. Five minutes after the bolus, check the ACT, and give an extra bolus of 0.3 mg/kg if it is needed.
For HIT/HITTS, the adult dose is an IV bolus of 0.75 mg/kg, followed by a continuous infusion at 1.75 mg/kg/h for the length of the procedure.
Continuation of therapy
The IV infusion can be continued for up to 4 h after the procedure, if needed. After 4 h, an extra IV infusion of 0.2 mg/kg/h can be given for up to 20 h if the patient still needs it.
Concomitant therapy
Bivalirudin is meant to be used together with aspirin, at 300 to 325 mg/day.
Renal function impairment
If CrCl is 30 to 50 mL/min, give the infusion at 1.75 mg/kg/h. If CrCl is less than 30 mL/min, reduce the infusion rate to 1 mg/kg/h. For patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h. The bolus dose does not need to be reduced in any of these cases.
Side Effects
Bivalirudin can cause bleeding. Other reported effects, by body system: Body as a whole: fever, infection, sepsis. Cardiovascular: hypotension, syncope, vascular anomaly, ventricular fibrillation. Nervous: cerebral ischemia, confusion, facial paralysis. Respiratory: lung edema. Urogenital: kidney failure, oliguria.
Cautions & Contraindications
Warnings & Precautions
Bleeding Events: Although most bleeding associated with the use of Biva in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Biva administration. Biva should be used with caution in patients with disease states associated with an increased risk of bleeding. Coronary Artery Brachytherapy: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Biva in gamma brachytherapy. If a decision is made to use Biva during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
Contraindications
Bivalirudin should not be used in patients with active major bleeding or known hypersensitivity (including anaphylaxis) to bivalirudin or any of its components.
Pregnancy & Breastfeeding
Pregnancy Category B. There are no adequate, well-controlled studies of Bivalirudin in pregnant women. Since animal reproduction studies do not always predict how humans will respond, this medicine should be used during pregnancy only if clearly needed. Bivalirudin is meant to be used together with aspirin, and because of possible adverse effects on the newborn and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether bivalirudin passes into human breast milk. Because many drugs do pass into human milk, caution should be exercised when Bivalirudin is given to a nursing mother.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal Impairment
In patients with moderate and severe renal impairment, the clearance of Biva was reduced by approximately 20%. In dialysis-dependent patients it was reduced by approximately 80%. The infusion dose of Biva may need to be reduced in patients with renal impairment, and their anticoagulant status should be monitored.
Hemodialysis
Reduce the infusion rate to 0.25 mg/kg/h. The bolus dose does not need to be reduced.
Pediatric Use
The safety and effectiveness of Biva in pediatric patients have not been established.
Geriatric Use
Elderly patients had more bleeding events than younger patients. Even so, patients treated with Biva had fewer bleeding events than those given heparin in each age stratum.
Overdose
Overdoses of up to 10 times the recommended bolus or continuous infusion dose of Biva (bivalirudin) have been reported, both in clinical trials and in postmarketing reports. Many of these happened because the infusion dose wasn't adjusted in people with renal dysfunction, including people on hemodialysis. Some reports describe bleeding, and some describe deaths due to hemorrhage.
If an overdose is suspected, stop Biva immediately and watch the patient closely for signs of bleeding. There is no known antidote to Biva. Biva can be removed by hemodialysis.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Bivalirudin in a dry place at a temperature not above 30º C. Don't freeze it. Keep it out of reach of children.
Drug Interactions
Common questions about Biva 250 mg/5 ml
What is Biva 250 mg/5 ml IV Injection?
Biva 250 mg/5 ml IV Injection is a medicine that contains Bivalirudin. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Anti-platelet drugs group of medicines.
What is Biva used for?
Biva is used for: Angina Pectoris.
What are the side effects of Biva?
Bivalirudin can cause bleeding. Other reported effects, by body system: Body as a whole: fever, infection, sepsis.
Can I take Biva during pregnancy or while breastfeeding?
Pregnancy Category B. There are no adequate, well-controlled studies of Bivalirudin in pregnant women. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Biva?
Overdoses of up to 10 times the recommended bolus or continuous infusion dose of Biva (bivalirudin) have been reported, both in clinical trials and in postmarketing reports. Many of these happened because the infusion dose wasn't adjusted in people with renal dysfunction, including people on hemodialysis. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Biva?
Keep Bivalirudin in a dry place at a temperature not above 30º C. Don't freeze it.
Can I take other medicines with Biva?
Some medicines can interact with Bivalirudin, for example: Heparin Sodium, Warfarin Sodium. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Biva?
Biva is a prescription (Rx) medicine. Take it as your doctor advises.