Angiomax, Angiox

Bivalirudin Injection is used for the prevention of blood clots in patients who suffer with severe chest pains or patients undergoing angioplasty.

Generic Angiomax/ Angiox

Bivalirudin

Bivasave

vial

Piramal H.C., Abbott

Injection

250 mg

India

Angiomax, Angiox

Introduction to Angiomax and Angiox

Overview of Angiomax and Angiox

Angiomax and Angiox are commonly used anticoagulants in medicine that help prevent clot formation during procedures by acting as direct thrombin inhibitors.

Historical Background and Development

Bivalirudin was first created in the 1990s as a man-made substitute for hirudin, an anticoagulant extracted from leeches. Signifying an advancement, in anticoagulation treatment by providing a safer and more precise method.

FDA Approval and Regulatory Status

The Food and Drug Administration (FDA) granted approval for Angiomax in the year 2000 due to its proven effectiveness in decreasing issues during coronary intervention (PCI). Across the world, various regulatory agencies have also given their support for its use, ensuring that it is accessible for life-saving procedures.

Significance in Modern Medicine

Angiomax and Angiox have played a role in improving safety during invasive cardiovascular procedures by offering quick and reversible effects essential in modern healthcare practices.

Uses of Angiomax and Angiox

Primary Indications

Use in Anticoagulation During Percutaneous Coronary Intervention (PCI)

Angiomax is primarily used to prevent thrombus formation in patients undergoing PCI. Its ability to target thrombin directly reduces procedural risks significantly.


Use in Treatment of Acute Coronary Syndromes (ACS)

In the field of ACS (Acute Coronary Syndrome) Angiomax provides an option compared to blood thinners by effectively preventing clots, with reduced chances of bleeding complications.

Specialized Applications

Use in Heparin-Induced Thrombocytopenia (HIT)

Angiomax offers an alternative for individuals with HIT by bypassing the dangers linked with heparin treatment.

Off-Label Uses

Use in Extracorporeal Membrane Oxygenation (ECMO)

Angiomaxs anticoagulant properties in ECMO are used to stop clotting in the circuit and help maintain a flow of blood outside the body.


Use in Left Ventricular Assist Devices (LVADs)

Its versatility shines through in how it handles the complexities of dealing with LVAD-related blood clot issues.

Other Emerging Off-Label Applications

Recent studies indicate that there are possibilities for utilizing treatments in conditions related to blood clotting issues that go beyond the usual reasons for using them.

Composition and Formulation

Active Ingredients in Angiomax and Angiox

The main ingredient in Bivalirudin is a man-made peptide that works by blocking the activity of thrombin.


Inactive Components and Their Role

The additional components, like mannitol and sodium hydroxide help keep the solution stable and make sure it can dissolve properly for IV delivery.

Available Dosage Forms

Angiomax and Angiox come in a form that can be mixed with liquid for dosing when giving the medication.

Angiomax vs heparin

Angiomax interacts with thrombin to prevent its action, whereas heparin accelerates the inactivation of activated blood clotting factors by antithrombin. Angiomax is classified as a type of drug known as Bivalirudin and functions as an inhibitor of thrombin activity, within the bodys coagulation system.

Dosage and Administration

Angiomax dosing

The usual treatment for PCI includes giving a dose followed by a drip that is adjusted based on the individual needs of the patient.

Adjustments Based on Renal Function

Patients with kidney problems need their medication doses adjusted to avoid build-up and potential issues that may arise from it.

Administration Techniques

Healthcare providers closely monitor coagulation parameters to ensure an onset when administering intravenously.

Special Considerations for Different Patient Populations

Elderly and pediatric patients require personalized dosing for the balance of safety and effectiveness.

Angiomax mechanism of action

Direct Thrombin Inhibition

Angiomax binds directly to thrombin, neutralizing its role in clot formation and reducing thrombotic risks.

Effects on Coagulation Cascade

By targeting thrombin, Angiomax disrupts the coagulation cascade, ensuring effective anticoagulation.

Comparison with Other Anticoagulants

Angiomax works differently from heparin as it doesn't rely on antithrombin for its effects and offers a consistent response in blood thinning properties.

Angiomax half life

Bivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function. The total body clearance of bivalirudin in PTCA patients with normal renal function is 3.4 mL/min/kg.

Side Effects of Angiomax and Angiox

Common Side Effects

Bleeding and Hematoma Formation

Minor bleeding and hematoma formation at the injection site are common but manageable with proper technique.

Pain or Discomfort at the Injection Site

Patients may experience localized discomfort, which typically resolves without intervention.

Serious Adverse Reactions

Allergic Reactions

In instances of hypersensitivity reactions. Necessitate prompt medical assistance.

Thrombocytopenia

It's essential to keep an eye on platelet levels throughout treatment due to the possibility of a decrease in the count.


Warnings and Contraindications

Absolute Contraindications

Known Hypersensitivity to Bivalirudin

Patients with a known allergy to bivalirudin should not receive Angiomax.

Active Major Bleeding

Active bleeding contraindicates its use, as it could exacerbate the condition.

Relative Contraindications

Recent Surgery or Trauma

Caution is advised in patients with recent surgical or traumatic injuries due to increased bleeding risks.


Severe Hypertension

Uncontrolled hypertension may elevate the risk of hemorrhagic complications.

Black Box Warnings

Healthcare professionals need to stay alert to the risk of bleeding by focusing on selecting and monitoring patients with care.

Drug Interactions

Interactions with Other Anticoagulants

Combining Angiomax or Angiox with other anticoagulants, such as warfarin or heparin, can significantly increase the risk of bleeding. These interactions demand careful patient evaluation and monitoring to mitigate adverse outcomes.

  • Concurrent use may potentiate anticoagulant effects.
  • Monitoring of coagulation parameters is critical.
  • Avoid co-administration unless absolutely necessary.

Interactions with Medications Affecting Hemostasis

Drugs influencing hemostasis, such as antiplatelet agents or thrombolytics, can amplify bleeding risks when used alongside Angiomax or Angiox.

  • Aspirin and clopidogrel require dose adjustments when co-administered.
  • Thrombolytics like alteplase heighten hemorrhagic risks.

Potential Food and Supplement Interactions

While food interactions are minimal, supplements such as omega-3 fatty acids and high doses of vitamin E may exacerbate anticoagulant effects. Avoiding such combinations is advisable during treatment.

Special Populations

Administration to Elderly Patients

Risks and Benefits Assessment

Elderly patients often present with comorbidities that elevate the complexity of treatment. While Angiomax offers effective anticoagulation, the potential for renal impairment and increased bleeding susceptibility requires careful assessment.


Dosage Adjustments for Comorbidities

In the presence of renal dysfunction or cardiovascular conditions, dose adjustments are essential to minimize adverse effects. Close monitoring ensures therapeutic efficacy without undue risk.

Administration to Pregnant Women and Nursing Mothers

Pregnancy Category and Risk Analysis

Angiomax is classified under pregnancy category B, indicating that animal studies have not shown fetal risk, but human data is limited. Its use should be restricted to situations where benefits outweigh potential risks.

Recommendations for Breastfeeding

Due to the lack of information about how Angiomax passes into breast milk in humans, it is recommended that nurses be cautious when giving it to mothers. It may be advisable to explore feeding options while undergoing treatment.

Administration to Children

Limited Pediatric Data and Off-Label Considerations

There is information regarding the use of Angiomax in pediatric patients, and it is mainly administered off label for children's treatment purposes as of now.

Overdosage and Management

Symptoms of Overdose

Symptoms of an overdose can manifest as bleeding episodes and low blood pressure along with indicators of shock; it is essential to identify them early to avoid severe and potentially fatal outcomes.

Immediate Management Steps

Immediate cessation of Angiomax infusion is the first step. Supportive measures, including fluid replacement and monitoring vital signs, are essential.

Use of Reversal Agents and Supportive Therapy

In situations where a specific antidote is unavailable, recombinant factor VIIA might be an option to consider in cases. Furthermore, transfusions and coagulation factors could also help promote healing and recovery.

Important Precautions

Monitoring Coagulation Parameters

It's important to keep a watch over the activated clotting time (ACT) as well as other coagulation factors while undergoing treatment to make sure the right levels are maintained without causing any excessive bleeding risks.

Ensuring Proper Hydration and Renal Function

Maintaining adequate hydration supports renal clearance of Angiomax, reducing the likelihood of drug accumulation and associated toxicities.

Avoidance of Concomitant Use of Certain Drugs

It is best to avoid mixing Angiomax with drugs that can increase the risk of bleeding unless it is absolutely necessary to do so in situations where careful monitoring is crucial.

Careful Administration Guidelines

Pre-Administration Assessment

Before starting Angiomax treatment for a patient, it is crucial to review their history, which includes looking at their past use of blood thinners and any bleeding disorders they may have had in the past.

Managing Patients with Renal Impairment

Assess the kidney function. Adjust the dosage as needed to avoid drug buildup and the risk of overdose.


Avoiding High-Risk Scenarios

It's best to avoid using Angiomax in cases where the potential for bleeding is higher than the expected advantages. For example, in situations of uncontrolled high blood pressure or recent significant surgeries.

Handling and Storage of Angiomax and Angiox

Remember to keep Angiomax and Angiox at room temperatures ranging from 20°C, to 25°C (68°F to 77°F). Make sure to shield them from sunlight and moisture exposure.

Stability After Reconstitution

After mixing it up with care and attention to instructions, storage is recommended for stability for 24 hours, but it is best to dispose of any leftovers after that time has passed.

Safe Handling and Disposal

Make sure to follow your regulations when getting rid of expired medication and refrain from flushing it down drains to reduce harm to the environment.

Handling Precautions for Healthcare Providers

Protection from Occupational Exposure

Remember to wear gloves and the necessary protective gear while handling and giving Angiomax to reduce the chances of exposure.

Guidelines for Safe Preparation and Administration

Be sure to make the medication in an environment. Carefully confirm the doses for accuracy so mistakes are avoided when giving it to patients.

Angiomax, Angiox FAQ

What is Angiomax used for?

Angiomax is a type of blood thinner known as a thrombin inhibitor, which assists in stopping the development of blood clots in the body. It is prescribed to individuals experiencing chest pain and other medical conditions undergoing angioplasty to blockages in arteries and prevent clot formation.

Why Angiomax instead of heparin?

The data indicates that using bivalirudin (Angiomax, from The Medicines Company) in primary PCI procedures results in 30-day clinical outcomes due to notable decreases in major bleeding incidents and the need for transfusions compared to using heparin alone or with a GPI.

How long does Angiomax last?

24 hrs

What is the difference between heparin and bivalirudin?

The studies have revealed that Bivalirudin is linked to an incidence of bleeding compared to heparin.

When do you use Angiomax?

Recommended for administering as a blood in individuals with angina who are receiving percutaneous transluminal coronary angioplasty (PTCA).

How do you mix Angiomax?

Angiomax should be administered through bolus injection and continuous infusion once reconstituted and diluted correctly as directed. For every 250 mg vial of Angiomax product available, it is advised to mix with 5 mL of Sterile Water for Injection (US Pharmacopeia). Carefully stir the solution until all contents are completely dissolved.

What is the antidote for Angiomax?

No known antidote

What is another name for Angiomax?

Bivalirudin

What is the half-life of Angiomax?

In PTCA patients with normal kidney function, bivalirudin has a half-life of 25 minutes and a total body clearance of 3,7 mL/min/kg.

Why Angiomax over heparin?

Preventing bleeding complications

When is Angiomax used?

Angiomax is administered to individuals experiencing chest discomfort or similar conditions while undergoing a procedure to clear blocked arteries.

Do you check ACT with Angiomax?

It is advisable to evaluate the safety and efficacy of bivalirudin by checking the activated clotting time (ACT) 5 minutes after administering the bolus dose.

What category is Angiomax?

Reversible direct thrombin inhibitor

What is the difference between bivalirudin and heparin?

When it comes to treating blood clotting issues, Heparin is often the go-to option, whereas Bivalirudin stands out as a direct thrombin inhibitor known for its antiischemic effects and reduced bleeding risks in PCI procedures.

What is the anticoagulant activity of bivalirudin?

After being injected, Bivalirudin quickly stops the activity of thrombin in the body, leading to an anticoagulant impact.

Is bivalirudin an antiplatelet?

During a PCI procedure, bivalirudin could offer benefits by not only preventing blood clotting but also reducing platelet activity significantly.

What is the duration of action of bivalirudin?

The half-life of bivalirudin is around 25 minutes.

What are the indications for using bivalirudin?

Patients undergoing intervention (PCI), including those with heparin-induced thrombotic disorders, can benefit from the use of Bivalirudin Injection, an anticoagulant medication.

How long to hold bivalirudin?

Ensure that bivalirudin is discontinued 4 hours before the planned surgical procedure or lumbar puncture.

What is the contraindication for bivalirudin?

Active significant bleeding and hypersensitivity reactions (such as anaphylaxis) due to Angiomax or its ingredients.

How is bivalirudin cleared?

The medication is mainly removed from the body through breakdown within blood vessels and excretion via the kidneys in the urine, showing a prolonged duration of action in individuals with kidney dysfunction.

What is Angiomax used for?

Angiomax is a medication that acts as a blood thinner by inhibiting thrombin, thereby reducing the risk of blood clot formation in individuals experiencing chest pain or undergoing angioplasty to unblock arteries.

Why Angiomax instead of heparin?

The information indicates that performing PCI using bivalirudin (brand name Angiomax, from The Medicines Company) leads to 30-day overall patient outcomes by noticeably lowering instances of major bleeding events and the need for transfusions compared to using heparin alone or with a GPI (glycoprotein IIa/IIIa inhibitor).

When do you use Angiomax?

Recommended for patients with angina undergoing transluminal coronary angioplasty (PTCA) as a blood thinning treatment choice.

How do you mix Angiomax?

Angiomax is meant to be given through an injection into a vein and then followed by an infusion once it has been mixed with Sterile Water for Injection in each 250 mg vial by adding 5 mL and gently swirling until everything is dissolved.

When is Angiomax used?

Angiomax is prescribed to help prevent blood clot formation in individuals experiencing chest discomfort or other related conditions while undergoing a procedure known as angioplasty which aims to clear blockages in arteries.

Do you check ACT with Angiomax?

It is advised to check the safety and efficiency of bivalirudin by measuring the activated clotting time (ACT) 5 minutes after administering the bolus dose.

What is the difference between bivalirudin and heparin?

The preferred option for therapy is typically Heparin; however, a recent alternative called bivalirudin acts as a direct thrombin inhibitor with noted anti-ischemic effects and reduced bleeding risks in percutaneous coronary intervention (PCI).

What is the anticoagulant activity of bivalirudin?

Upon receiving a dose of bivalirudin, thrombin activity is promptly suppressed, leading to an anticoagulant impact.

Is bivalirudin an antiplatelet?

Using bivalirudin during PCI could offer antiplatelet benefits along with its effects.

What is the duration of action of bivalirudin?

The duration of action of bivalirudin is around 25 minutes.

What are the indications for using bivalirudin?

Patients undergoing intervention (PCI), including those with heparin-induced thromboembolic disorders, can benefit from the use of Bivalirudin Injection, an anticoagulant medication.

How long to hold bivalirudin?

Make sure to stop taking bivalirudin at 4 hours before your planned surgery or lumbar puncture procedure.

What is the contraindication for bivalirudin?

Experiencing bleeding or having an allergic reaction, such as anaphylaxis, to Angiomax or any of its ingredients could occur.

How is bivalirudin cleared?

The medication is mostly removed from the body through breakdown in the blood vessels and excretion via the kidneys into the urine showing an extended time in patients with moderate to kidney impairment.

What is Angiomax used for?

Angiomax functions as a blood thinner by inhibiting thrombin, thereby reducing the risk of clot formation in individuals experiencing chest pain or undergoing angioplasty to blocked arteries.

Why Angiomax instead of heparin?

The data indicates that using bivalirudin (Angiomax, from The Medicines Company) in PCI procedures leads to 30-day overall clinical results by notably decreasing instances of major bleeding and the need for transfusions compared to heparin alone or in combination with a GPI.

What is the difference between heparin and bivalirudin?

Bivalirudin has been shown to be associated with less major bleeding than heparin

When do you use Angiomax?

Prescribed for patients with angina undergoing transluminal coronary angioplasty (PTCA) to prevent blood clots.

How do you mix Angiomax?

Angiomax is meant to be administered through an injection into the vein and a steady infusion after mixing with Sterile Water for Injection and swirling gently until fully dissolved in each 250 mg vial containing 5 mL of the solution.

Is bivalirudin an antiplatelet?

During a PCI procedure, bivalirudin could offer benefits in preventing platelet aggregation as well as acting as an anticoagulant.

What are the indications for using bivalirudin?

Bivalirudin Injection is a blood thinner used for patients receiving the intervention (PCI), including those with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and from thrombosis syndrome.

How long to hold bivalirudin?

Make sure to stop taking bivalirudin at 4 hours before your planned surgery or lumbar puncture procedure.

What is the contraindication for bivalirudin?

Active major bleeding; • Hypersensitivity (e.g., anaphylaxis) to Angiomax or its components

How is bivalirudin cleared?

The medication is mainly removed through breakdown in the blood vessels and excretion in the urine, with patients experiencing an extended half-life in cases of moderate to severe kidney impairment.

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