Desirudin

Desirudin
Black Box Warning
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

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

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. SPINAL/EPIDURAL HEMATOMAS: When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the use of indwelling spinal catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non- steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Likewise with such agents, the risk appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. The physician should consider the potential benefit versus risk before neuraxial intervention, in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Overview

Desirudin is a direct thrombin inhibitor that is FDA approved for the {{{indicationType}}} of deep vein thrombosis in patients undergoing elective hip replacement surgery. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hemorrhage, injection site mass, wound secretion, anemia, deep thrombophlebitis, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Prophylaxis of Deep Vein Thrombosis

• Dosing Information

• All patients should be evaluated for bleeding disorder risk before prophylactic administration of Iprivask.

• Initial Dosage

• In patients undergoing hip replacement surgery, the recommended dose of Iprivask is 15 mg every 12 hours administered by subcutaneous injection with the initial dose given up to 5 to 15 minutes prior to surgery, but after induction of regional block anesthesia, if used. Up to 12 days administration (average duration 9 to 12 days) of Iprivask has been well tolerated in controlled clinical trials.

• Dose in Renal Impairment

This image is provided by the National Library of Medicine.

• Dose in Hepatic Impairment

• In the absence of clinical studies in this population, dosing recommendations cannot be made at this time.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Desirudin in adult patients.

Non–Guideline-Supported Use

Prophylaxis of Coronary Thrombolysis in Acute Coronary Syndrome

• Equivalent or slightly better efficacy compared to heparin for thrombolysis in patients with acute coronary syndrome; desirudin administration is also associated with a lower early reinfarction rate.

Condition2

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Desirudin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

WARNING See full prescribing information for complete Boxed Warning. SPINAL/EPIDURAL HEMATOMAS: When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as Iprivask may be at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the use of indwelling spinal catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non- steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Likewise with such agents, the risk appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. The physician should consider the potential benefit versus risk before neuraxial intervention, in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Desirudin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Desirudin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Desirudin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Desirudin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Desirudin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Desirudin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Desirudin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Desirudin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Desirudin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Desirudin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Desirudin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Desirudin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Desirudin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Desirudin in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Desirudin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Desirudin in the drug label.

Pharmacology

There is limited information regarding Desirudin Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Desirudin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Desirudin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Desirudin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Desirudin in the drug label.

Condition1

• Description

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Desirudin in the drug label.

Precautions with Alcohol

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

Brand Names

• Iprivask®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

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

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