Bivalirudin: Difference between revisions

Bivalirudin
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 14:51, 9 July 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

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Overview

Bivalirudin is a direct thrombin inhibitor that is FDA approved for the {{{indicationType}}} of anticoagulation in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) and in patients with unstable angina or risk of heparin induced thrombocytopenia (HIT) undergoing percutaneous coronary intervention (PCI).. Common adverse reactions include bleeding, headache, thrombocytopenia and fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Percutaneous Transluminal Coronary Angioplasty (PTCA)

Dosing Information

Initial dose: 0.75 mg/kg IV bolus
Maintenance dose: 1.75 mg/kg/hr IV infusion for the duration of the procedure
May be continued 4 hours post-procedure

Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.

Percutaneous Coronary Intervention (PCI)

Dosing Information

Initial dose: 0.75 mg/kg IV bolus
Maintenance dose: 1.75 mg/kg/hr IV infusion for the duration of the procedure
May be continued 4 hours post-procedure

Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information/Recommendation

(Dosage)

Condition 2

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information/Recommendation

(Dosage)

Non–Guideline-Supported Use

Condition 1

Dosing Information

(Dosage)

Condition 2

Dosing Information

(Dosage)

Condition 3

Dosing Information

(Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Bivalirudin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bivalirudin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bivalirudin in pediatric patients.

Contraindications

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

Warnings

Bleeding Events

Although most bleeding associated with the use of bivalirudin 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 bivalirudin administration.
Bivalirudin 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 bivalirudin in gamma brachytherapy.
If a decision is 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 the catheter or vessels.

Adverse Reactions

Clinical Trials Experience

Bleeding

In 6010 patients undergoing PCI treated in the REPLACE-2 trial, bivalirudin patients exhibited statistically significantly lower rates of bleeding, transfusions, and thrombocytopenia as noted in Table 2.

In 4312 patients undergoing PTCA for treatment of unstable angina in 2 randomized, double-blind studies comparing bivalirudin to heparin, bivalirudin patients exhibited lower rates of major bleeding and lower requirements for blood transfusions. The incidence of major bleeding is presented in Table 3. The incidence of major bleeding was lower in the bivalirudin group than in the heparin group.

In the AT-BAT study, of the 51 patients with HIT/HITTS, 1 patient who did not undergo PCI had major bleeding during CABG on the day following angiography. Nine patients had minor bleeding (mostly due to access site bleeding), and 2 patients developed thrombocytopenia.

Other Adverse Reactions

Adverse reactions, other than bleeding, observed in clinical trials were similar between the bivalirudin treated patients and the control groups. Adverse reactions (related adverse events ) seen in clinical studies in patients undergoing PCI and PTCA are shown in Tables 4 and 5.

Serious, non-bleeding adverse events were experienced in 2% of 2161 bivalirudin-treated patients and 2% of 2151 heparin-treated patients. The following individual serious non-bleeding adverse events were rare (>0.1% to <1%) and similar in incidence between bivalirudin- and heparin-treated patients.

These events are listed by body system:

Body as a Whole

Cardiovascular

Nervous

Respiratory

Lung edema

Urogenital

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during postapproval use of Angiomax: fatal bleeding; hypersensitivity and allergic reactions including reports of anaphylaxis; lack of anticoagulant effect; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes.

Drug Interactions

Drug 1
Drug 2
Drug 3
Drug 4
Drug 5

Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Y-Site

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Admixture

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Syringe

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

TPN/TNA

Compatible

Solution 1
Solution 2
Solution 3

Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
Solution 3

Incompatible

Solution 1
Solution 2
Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology


Bivalirudin
Systematic (IUPAC) name
?
Identifiers
CAS number	?
ATC code	?
PubChem	?
Chemical data
Formula	?
Mol. mass	?
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Bivalirudin Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Bivalirudin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Bivalirudin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Bivalirudin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Bivalirudin Brand Names in the drug label.

Look-Alike Drug Names

(Paired Confused Name 1a) — (Paired Confused Name 1b)
(Paired Confused Name 2a) — (Paired Confused Name 2b)
(Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

@@ Line 73: / Line 73: @@
 *An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin in gamma brachytherapy.
 *If a decision is 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 the catheter or vessels.
-|clinicalTrials=======Central Nervous System======
+|clinicalTrials=====Bleeding====
-: (list/description of adverse reactions)
+In 6010 patients undergoing PCI treated in the REPLACE-2 trial, bivalirudin patients exhibited statistically significantly lower rates of bleeding, transfusions, and thrombocytopenia as noted in Table 2.
-======Cardiovascular======
+[[Image:Bivalirudin_02.png|thumb|600px|left]]
+{{clr}}
-: (list/description of adverse reactions)
+In 4312 patients undergoing PTCA for treatment of unstable angina in 2 randomized, double-blind studies comparing bivalirudin to heparin, bivalirudin patients exhibited lower rates of major bleeding and lower requirements for blood transfusions. The incidence of major bleeding is presented in Table 3. The incidence of major bleeding was lower in the bivalirudin group than in the heparin group.
-======Respiratory======
+[[Image:Bivalirudin_03.png|thumb|600px|left]]
+{{clr}}
-: (list/description of adverse reactions)
+In the AT-BAT study, of the 51 patients with HIT/HITTS, 1 patient who did not undergo PCI had major bleeding during CABG on the day following angiography. Nine patients had minor bleeding (mostly due to access site bleeding), and 2 patients developed thrombocytopenia.
-======Gastrointestinal======
+====Other Adverse Reactions====
+Adverse reactions, other than bleeding, observed in clinical trials were similar between the bivalirudin treated patients and the control groups.
+Adverse reactions (related adverse events ) seen in clinical studies in patients undergoing PCI and PTCA are shown in Tables 4 and 5.
+[[Image:Bivalirudin table 4.png|thumb|600px|left]]
+{{clr}}
+[[Image:Bivalirudin table 5.png|thumb|600px|left]]
+{{clr}}
-: (list/description of adverse reactions)
+Serious, non-bleeding adverse events were experienced in 2% of 2161 bivalirudin-treated patients and 2% of 2151 heparin-treated patients. The following individual serious non-bleeding adverse events were rare (>0.1% to <1%) and similar in incidence between bivalirudin- and heparin-treated patients.
-======Hypersensitive Reactions======
+These events are listed 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]]
-: (list/description of adverse reactions)
-======Miscellaneous======
-: (list/description of adverse reactions)
+|postmarketing=Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
-=====Condition 2=====
+The following adverse reactions have been identified during postapproval use of Angiomax: fatal bleeding; hypersensitivity and allergic reactions including reports of anaphylaxis; lack of anticoagulant effect; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes.
-======Central Nervous System======
-: (list/description of adverse reactions)
-======Cardiovascular======
-: (list/description of adverse reactions)
-======Respiratory======
-: (list/description of adverse reactions)
-======Gastrointestinal======
-: (list/description of adverse reactions)
-======Hypersensitive Reactions======
-: (list/description of adverse reactions)
-======Miscellaneous======
-: (list/description of adverse reactions)
-|postmarketing=(Description)
 |drugInteractions=* Drug 1
 * Drug 2