bivalirudin

medtigo

bivalirudin

Brand Name :

Angiomax RTU,Angiomax

Synonyms :

bivalirudin

Class :

Hematologists, Anti-coagulants; Cardiovascular, Anti-coagulants

Action and Spectrum

Actions and Spectrum:

bivalirudin is a direct thrombin inhibitor that works by binding to the active site of thrombin and blocking its ability to convert fibrinogen to fibrin, which is the final step in the clotting cascade. By inhibiting thrombin, bivalirudin prevents the formation of blood clots.

bivalirudin has a broad spectrum of activity against both arterial and venous thrombosis. It is primarily used to prevent blood clotting in patients undergoing percutaneous coronary intervention (PCI) or with heparin-induced thrombocytopenia (HIT). In this condition, heparin use causes a significant drop in platelet count and increases the risk of blood clotting.

In addition to its anti-coagulant activity, bivalirudin has fibrinolytic properties, which help break down existing blood clots. This makes it helpful in treating acute myocardial infarction (AMI), particularly in patients who cannot receive fibrinolytic therapy due to an increased risk of bleeding.

Dosing & Uses

Drug Interaction

Adverse Reaction

Frequency defined

>10%

General pain (15%)

Hemorrhage, minor (13.6%)

Hypotension (12%)

Back pain (42%)

Nausea (15%)

Headache (12%)

1-10%

Insomnia (7%)

Hypertension (6%)

Vomiting (6%)

Dyspepsia (5%)

Fever (5%)

Urinary retention (4%)

≥3g/dL fall in Hgb (1.9%)

RBC transfusions (1.3%)

Injection site pain (8%)

Pelvic pain (6%)

Anxiety (6%)

Bradycardia (5%)

Abdominal pain (5%)

Nervousness (5%)

Hemorrhage, major (2.3%)

TIMI minor bleeding (1.3%)

Post-marketing reports

Pulmonary hemorrhage

INR increased

Cardiac tamponade

Black Box Warning

Contraindication / Caution

Contraindications/caution:

Contraindications:

Hypersensitivity: bivalirudin should not be used in patients with a known hypersensitivity to bivalirudin or its components.

Active Bleeding: bivalirudin is a potent anti-coagulant that can increase the risk of bleeding. It should not be used in patients with active bleeding or bleeding disorders.

Thrombocytopenia: bivalirudin can cause a drop in platelet count, increasing the risk of bleeding. It should not be used in patients with thrombocytopenia or a history of heparin-induced thrombocytopenia (HIT).

Severe liver disease: bivalirudin is primarily eliminated by the liver. In patients with severe liver disease, bivalirudin clearance may be decreased, leading to an increased risk of bleeding.

Pregnancy and lactation: bivalirudin should be used cautiously in pregnant or breastfeeding women, as its safety has not been established in these populations.

Surgery with high bleeding risk: bivalirudin should not be used in patients undergoing surgery with a high risk of bleeding, as it can increase the risk of bleeding complications

Caution:

Renal impairment: bivalirudin is primarily eliminated by the kidneys, and its clearance may be reduced in patients with renal impairment. Dose adjustment may be necessary for these patients to prevent bleeding complications.

Hepatic impairment: bivalirudin is metabolized by the liver, and its clearance may be reduced in patients with hepatic impairment. Dose adjustment may be necessary for these patients to prevent bleeding complications.

Elderly patients: Elderly patients may be more susceptible to the anti-coagulant effects of bivalirudin and may be at increased risk of bleeding complications.

Coagulation disorders: bivalirudin can increase the risk of bleeding in patients with coagulation disorders, such as hemophilia or von Willebrand disease. It should be used with caution in these patients.

Concurrent use of other anti-coagulants: bivalirudin should not be used concurrently with other anti-coagulants, as this can increase the risk of bleeding complications.

Use in children: The safety and efficacy of bivalirudin in pediatric patients have not been established, and it should be used with caution in this population.

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available

Lactation: Excretion of the drug in human breast milk is unknown

Pregnancy category:

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:

bivalirudin is a synthetic polypeptide that inhibits thrombin, a key enzyme in the coagulation cascade. Thrombin converts fibrinogen to fibrin, forming a clot that stops bleeding. bivalirudin binds to the active site of thrombin, preventing it from converting fibrinogen to fibrin and thereby preventing clot formation.

bivalirudin has a rapid onset of action and a short half-life, making it an attractive alternative to heparin in specific clinical settings. It is given by intravenous infusion and has a dose-dependent anti-coagulant effect.

Pharmacodynamics:

bivalirudin is a direct thrombin inhibitor used as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) and those with heparin-induced thrombocytopenia (HIT). The pharmacodynamics of bivalirudin is characterized by its ability to bind to the active site of thrombin and inhibit its function.

bivalirudin inhibits thrombin by specifically binding to its active site, which prevents the conversion of fibrinogen to fibrin and subsequently reduces the formation of blood clots. bivalirudin has a rapid onset of action and a short half-life, making it an attractive option for PCI procedures.

Pharmacokinetics:

Absorption

bivalirudin is administered intravenously and is rapidly and completely absorbed into the bloodstream.

Distribution

bivalirudin has a low volume of distribution and is mainly distributed in the plasma. It does not bind significantly to plasma proteins, and its distribution is not affected by age, sex, or body weight.

Metabolism

bivalirudin is metabolized by proteolytic cleavage by plasma proteases, including thrombin and other serine proteases. bivalirudin metabolites are inactive and eliminated from the body by the kidneys.

Elimination and Excretion

bivalirudin is eliminated primarily by the kidneys, with about 20% of the drug excreted unchanged in the urine. bivalirudin clearance depends on renal function, and dosage adjustment is recommended in patients with impaired renal function.

Adminstartion

Administration:

bivalirudin is a medication administered intravenously (IV) and is typically given in a hospital setting. The recommended dosage and administration of bivalirudin depends on the indication for use, the patient’s weight, and renal function.
For patients undergoing percutaneous coronary intervention (PCI), bivalirudin is given as an initial bolus dose of 0.75 mg/kg, followed by a continuous infusion of 1.75 mg/kg/hour for the duration of the procedure. Based on clinical judgment, the infusion is usually continued for up to 4 hours after the procedure is completed and longer if necessary.
In patients with heparin-induced thrombocytopenia (HIT), bivalirudin is given as an initial bolus dose of 0.15 mg/kg, followed by a continuous infusion of 1.75 mg/kg/hour. The infusion is usually continued until platelet counts have recovered and for up to 4 days.

Patient Information Leaflet

Patient information leaflet

Generic Name: bivalirudin

Why do we use bivalirudin?

bivalirudin is a medication that is primarily used as an anticoagulant in two clinical settings:

Percutaneous coronary intervention (PCI): bivalirudin is an anti-coagulant during PCI, a minimally invasive procedure to open blocked or narrowed coronary arteries. bivalirudin is given to prevent the formation of blood clots during the procedure and to reduce the risk of complications such as heart attack or stroke.
Heparin-induced thrombocytopenia (HIT): bivalirudin is also used in patients with HIT, whereas heparin, another commonly used anti-coagulant, causes a decrease in platelet count and an increased risk of blood clot formation. bivalirudin is an alternative anti-coagulant in these patients to prevent further blood clotting.

bivalirudin

No data available for drug.

DRUG INTERACTION

bivalirudin

&

bivalirudin +

Contraindicated

Serious Use Alternative

Monitor Closely

Minor

bivalirudin

No data available for drug.

DRUG INTERACTION

bivalirudin

&

bivalirudin +

Contraindicated

Serious Use Alternative

Monitor Closely

Minor

medtigo

bivalirudin

Brand Name :

Synonyms :

Class :

Action and Spectrum

Dosing & Uses

Drug Interaction

Adverse Reaction

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pharmacology

Adminstartion

Patient Information Leaflet