Argatroban Injection, USP Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION.

ARGATROBAN injection, for intravenous infusion only

Initial U.S. Approval: 2000

INDICATIONS AND USAGE

Argatroban is a direct thrombin inhibitor indicated:

•
For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1)
•
As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2)

DOSAGE AND ADMINISTRATION

Argatroban Injection must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection to a final concentration of 1 mg/mL. (2.1)

 

Heparin-Induced Thrombocytopenia

The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. (2.2)

 

Percutaneous Coronary Intervention

The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. (2.3)

DOSAGE FORMS AND STRENGTHS

250 mg/2.5 mL single-dose vial. (3)

CONTRAINDICATIONS

•
Major bleeding. (4)
•
History of hypersensitivity to this product. (4)

WARNINGS AND PRECAUTIONS

•
Hemorrhage can occur. Unexplained fall in hematocrit or blood pressure may indicate hemorrhage. (5.1)
•
Hepatic impairment: Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI in patients with clinically significant hepatic impairment. (5.2)

ADVERSE REACTIONS

•
HIT patients: The most common (> 5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. (6)
•
PCI patients: The most common (> 5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Heparin: Allow sufficient time for heparin's effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. (7.1)
•
Warfarin: Concomitant use results in increased prolongation of PT and INR. (7.2)
•
Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not been established. (7.4, 7.5)

USE IN SPECIFIC POPULATIONS

•
Lactation: Discontinue nursing or drug, taking into account the importance of the drug to the mother. (8.2)
•
Pediatric use: Safety and effectiveness have not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2019

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION.

ARGATROBAN injection, for intravenous infusion only

Initial U.S. Approval: 2000

INDICATIONS AND USAGE

Argatroban is a direct thrombin inhibitor indicated:

•
For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1)
•
As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2)

DOSAGE AND ADMINISTRATION

Argatroban Injection must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection to a final concentration of 1 mg/mL. (2.1)

 

Heparin-Induced Thrombocytopenia

The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. (2.2)

 

Percutaneous Coronary Intervention

The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. (2.3)

DOSAGE FORMS AND STRENGTHS

250 mg/2.5 mL single-dose vial. (3)

CONTRAINDICATIONS

•
Major bleeding. (4)
•
History of hypersensitivity to this product. (4)

WARNINGS AND PRECAUTIONS

•
Hemorrhage can occur. Unexplained fall in hematocrit or blood pressure may indicate hemorrhage. (5.1)
•
Hepatic impairment: Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI in patients with clinically significant hepatic impairment. (5.2)

ADVERSE REACTIONS

•
HIT patients: The most common (> 5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. (6)
•
PCI patients: The most common (> 5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Heparin: Allow sufficient time for heparin's effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. (7.1)
•
Warfarin: Concomitant use results in increased prolongation of PT and INR. (7.2)
•
Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not been established. (7.4, 7.5)

USE IN SPECIFIC POPULATIONS

•
Lactation: Discontinue nursing or drug, taking into account the importance of the drug to the mother. (8.2)
•
Pediatric use: Safety and effectiveness have not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2019
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