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ARGATROBAN is a brand name for Argatroban, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Argatroban is indicated as anticoagulant therapy in patients with heparin-induced thrombocytopenia syndrome, who, in the opinion of their attending physician, require anticoagulation. 1.1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Argatroban in pediatric patients…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution 06/2024 Table of Contents Sections or subsections that are not applicable at the time of authorization are not listed. 7
1 Adverse Drug Reaction Overview Adverse events occurring with Argatroban are those which are anticipated for patients presenting with HIT or HITTS (heparin-induced thrombocytopenia with thrombosis) syndrome. The incidence of any of the primary efficacy endpoints of death, amputations or new thrombosis has been considered as the most serious adverse events.
The most common adverse event was bleeding, but major bleeding events with Argatroban did not occur more frequently than in historical controls. Other common adverse reactions included diarrhea, dyspnea, hypotension, apnea, chest pain, sepsis, dizziness, fever ventricular tachycardia and nausea and vomiting.
2 Clinical Trial Adverse Drug Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following safety information is based upon the 568 patients treated with Argatroban in the prospective pivotal clinical studies in patients with heparin-induced thrombocytopenia with and without thrombosis syndrome.
568 adult patients were treated with Argatroban and 193 adult patients made up the historical control group. Patients were required to have a clinical diagnosis of heparin-induced thrombocytopenia, either without thrombosis (HIT) or with thrombosis (HITTS) and be males or non-pregnant females between the age of 18 and 80 years old.
HIT/HITTS was defined by a fall in platelet count to less than 100,000/L or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than HIT. Patients with HITTS also had presence of an arterial or venous thrombosis documented by appropriate imaging techniques or supported by clinical evidence such as acute myocardial infarction, stroke, pulmonary embolism, or other clinical indications of vascular occlusion.
General Argatroban is intended for use as an anticoagulant in patients with heparin-induced thrombocytopenia (HIT) syndrome. Hemorrhage can occur, especially in patients with disease states associated with a risk of bleeding. All patients should be carefully monitored.
Argatroban is intended for intravenous administration. All parenteral anticoagulants must be discontinued before administration of Argatroban.
Cardiovascular Hemorrhage:
Hemorrhage can occur at virtually any site in the body in patients receiving Argatroban. An unexplained fall in hematocrit, fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.
Argatroban should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. These include severe hypertension; immediately following lumbar puncture; spinal anesthesia; major surgery especially involving the brain, spinal cord, or eye; hematologic conditions associated with increased bleeding tendencies such as hemophilia, gastrointestinal lesions such as ulcerations.
Hepatic/Biliary/Pancreatic Caution should be exercised when administering Argatroban to patients with hepatic disease, by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Achievement of steady state aPTT levels may take longer and require more Argatroban dose adjustments ARGATROBAN (argatroban) Page 9 of 37 in patients with moderate hepatic impairment compared to patients with normal hepatic function.
The aPTT should be closely monitored and the dosage should be adjusted as indicated clinically. Argatroban should be used with caution in patients with severely impaired hepatic function, and only if the clinical benefit outweighs the risk.
Argatroban is contraindicated in patients • with active major bleeding (for example: overt bleeding in a critical organ/area or bleeding causing a fall in hemoglobin level ≥ 2g/dL or leading to a transfusion of ≥ 2 units) • who are hypersensitive to the drug or to any ingredient in the formulation • with hereditary fructose intolerance
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, patients with latent disease).
Serious Adverse Events:
Study Days 0-37: Table 3 shows the incidence of the primary efficacy endpoints [death (all cause), amputations (all cause), or new thrombosis, during study days 0-37; recorded as the most severe event] in the prospective and follow-on trials combined.
These events qualify as (Serious Adverse Events). Table 3 illustrates the safety profile of Argatroban with regard to these serious outcomes as compared to a historical control group. ARGATROBAN (argatroban) Page 11 of 37 Table 3. 124).
2% vs. 2% vs. 683). No clinically significant difference in minor bleed incidence was observed in either trial comparing Argatroban treated patients to historical controls. There were no cases of drug-related intracranial hemorrhage noted in either trial.
Most Common Reported Adverse Events in the Prospective Pivotal Clinical Trials:
The adverse events reported in this section are consistent with those which would be anticipated for a severely ill patient population who present with HIT/HITTS syndrome. In general, these patients had a mean age of 60+ years and were on complex concomitant medications.
No clinically significant safety trends with regard to Argatroban exposure are apparent from both pivotal trials adverse event data. There may be some evidence of a clinical trend for treated patients to experience milder gastrointestinal disturbances, such as nausea, or diarrhea.
Comparative Summary of Adverse Events for Prospective Pivotal Clinical Trials:
The following is a comparative summary of non-hemorrhagic adverse events in pivotal studies that were experienced in heparin-induced thrombocytopenia (HIT) patients treated with Argatroban. All adverse events occurring with frequency of ≥5% in treated patients, in either trial, are listed in descending order of frequency as they occurred in the first pivotal trial.
Table 4. Comparative Summary of Adverse Events – HIT Adverse Event ARG-911 n = 160 ARG-915 n = 125 Historic Control; n = 147 5% % % % Diarrhea 11 2 2 Dyspnea 8 9 9 Hypotension 7 5 3 ARGATROBAN (argatroban) Page 12 of 37 Adverse Event ARG-911 n = 160 ARG-915 n = 125 Historic Control; n = 147 Apnea 6 0 5 Chest Pain 6 2 2 Sepsis 6 3 14 Dizziness 5 2 0 Vomiting 5 3 0 Fever 4 6 2 Nausea 4 6 0 Tachycardia Ventricular 3 7 3 The following is a comparative summary of non-hemorrhagic adverse events in pivotal studies that were experienced in heparin-induced thrombocytopenia with thrombotic syndrome (HITTS) patients treated with Argatroban.
All adverse events occurring with frequency of 5% in treated patients, in either trial, are listed in descending order of frequency as they occurred in the first pivotal trial. Table 5. Comparative Summary of Adverse Events – HITTS Adverse Event ARG-911 n = 149 ARG-915 n = 139 Historic Control n = 46 5% % % % Hypotension 9 8 0 Pain 9 3 4 Apnea 8 0 7 […]
Close monitoring and dosage adjustment should be done as clinically indicated. Also, upon cessation of Argatroban infusion in patients with hepatic impairment, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of Argatroban (See 4 DOSAGE AND ADMINISTRATION).
Monitoring and Laboratory Tests Anticoagulation effects associated with Argatroban infusion at doses up to 40 mcg/kg/min are well- correlated with the activated partial thromboplastin time (aPTT). If aPTT monitoring is problematic (such as for those having antiphospholipid antibodies), other global clot-based tests sensitive to Argatroban include the prothrombin time (PT), the International Normalized Ratio (INR), the activated clotting time (ACT) and thrombin time (TT).
Plasma Argatroban concentrations also correlate well with anticoagulant effects (see 10 CLINICAL PHARMACOLOGY). The concomitant use of Argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone.
Alternative approaches for monitoring concurrent Argatroban and warfarin therapy are described in a subsequent section (see 9 DRUG INTERACTIONS and 4 DOSAGE AND ADMINISTRATION). 0 mcg/kg/min were administered with no medically significant safety concerns (see 4 DOSAGE AND ADMINISTRATION).
1 Pregnant Women There are no adequate and well controlled studies in which pregnant women have received Argatroban. Although animal reproductive studies have not revealed harm to the fetus (see 16 NON-CLINICAL TOXICOLOGY), these studies are not always predictive of the effects of a drug in humans.
Argatroban should only be used in pregnancy if the benefits outweigh the risks. 2 Breast-feeding Nursing women should discontinue breast feeding while taking Argatroban because of the potential risk for serious adverse reactions in nursing infants.
Although it is not known whether this drug is excreted in human milk, experiments in rats show that Argatroban is detected in milk. 3 Pediatrics The safety and effectiveness of Argatroban in patients below the age of 18 years have not been established.
Therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics ARGATROBAN (argatroban) Page 10 of 37 Dosage adjustment is not necessary in patients 65 years of age and older.