Argatroban
- Generic Name: argatroban injection
- Brand Name: Argatroban
Argatroban (Argatroban Injection) side effects drug center
- Related Drugs
- nausea,
- vomiting,
- diarrhea,
- stomach pain,
- fever,
- headache,
- back pain, or
- minor bleeding or irritation at the injection site.
- blood in the urine,
- blurred vision,
- chest pain,
- confusion,
- dizziness, or
- lightheadedness.
- easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
- unexpected pain or swelling;
- any bleeding that will not stop;
- a light-headed feeling, like you might pass out;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- urine that looks red, pink, or brown;
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); or
- signs of infection--fever, flu symptoms, mouth and throat ulcers, rapid heart rate, shallow breathing.
- infection;
- problems with heart function;
- fever;
- nausea, vomiting, diarrhea;
- low blood pressure;
- shortness of breath;
- headache, back pain; or
- chest pain.
- Risk of Hemorrhage [see WARNINGS AND PRECAUTIONS]
- Airway reactions (coughing, dyspnea): 10% or more
- Skin reactions (rash, bullous eruption): 1 to <10%
- General reactions (vasodilation): 1 to 10%
What Is Argatroban?
Argatroban Injection is a synthetic direct thrombin inhibitor used to prevent or treat thrombosis in adult patients with heparin-induced thrombocytopenia (HIT), and is also used as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). Argatroban injection is available in generic form.
What Are Side Effects of Argatroban?
Common side effects of Argatroban injection include:
Tell your doctor if you have serious side effects of Argatroban injection including:
Dosage for Argatroban
The recommended initial dose of argatroban injection for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion.
What Drugs, Substances, or Supplements Interact with Argatroban?
Argatroban may interact with mifepristone, blood thinners, nonsteroidal anti-inflammatory drugs (NSAIDs), anti-platelet drugs, medications that interact with alcohol, tipranavir, or any drugs that can increase your risk of bleeding. Tell your doctor all medications and supplements you use.
Argatroban During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using argatroban; it is not expected to be harmful to a fetus. However, aspirin is sometimes given with argatroban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. It is unknown if argatroban passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Argatroban Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Argatroban (Argatroban Injection)
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
Clinical Trials Experience
Adverse Events In Patients With HIT (With Or Without Thrombosis)
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following safety information is based on all 568 patients treated with argatroban in Study 1 and Study 2. The safety profile of the patients from these studies is compared with that of 193 historical controls in which the adverse events were collected retrospectively. Adverse events are separated into hemorrhagic and non-hemorrhagic events.
Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease ≥2 g/dL, that led to a transfusion of ≥2 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint. Minor bleeding was overt bleeding that did not meet the criteria for major bleeding.
Table 4 gives an overview of the most frequently observed hemorrhagic events, presented separately by major and minor bleeding, sorted by decreasing occurrence among argatroban-treated patients with HIT (with or without thrombosis).
Table 4: Major and Minor Hemorrhagic Adverse Events in
Patients With HIT*
| Arg atroban- tre ate d Patients (Study 1 and Study 2) (n = 568) % |
Historical Controlc (n=193) % |
|
| Major Hemorrhagic Eventsa | ||
| Overall bleeding | 5.3 | 6.7 |
| Gastrointestinal | 2.3 | 1.6 |
| Genitourinary and hematuria | 0.9 | 0.5 |
| Decrease in hemoglobin and hematocrit | 0.7 | 0 |
| Multisystem hemorrhage and DIC | 0.5 | 1 |
| Limb and BKA stump | 0.5 | 0 |
| Intracranial hemorrhage | 0 b | 0.5 |
| Minor Hemorrhagic Eventsa | ||
| Gastrointestinal | 14.4 | 18.1 |
| Genitourinary and hematuria | 11.6 | 0.8 |
| Decrease in hemoglobin and hematocrit | 10.4 | 0 |
| Groin | 5.4 | 3.1 |
| Hemoptysis | 2.9 | 0.8 |
| Brachial | 2.4 | 0.8 |
| *with or without thrombosis a) Patients may have experienced more than 1 adverse event. b) One patient experienced intracranial hemorrhage 4 days after discontinuation of argatroban and following therapy with urokinase and oral anticoagulation. c) The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel. DIC = disseminated intravascular coagulation. BKA = below-the-knee amputation |
||
Table 5 gives an overview of the most frequently observed non-hemorrhagic events sorted by decreasing frequency of occurrence (≥2%) among argatroban-treated HIT/HITTS patients.
Table 5 : Non-hemorrhagic Adverse Events in Patientsa
With HITb
| Arg atro ban-treated Patients (Study 1 and Study 2) (n = 568)% |
Historical Controlc (n=193)% |
|
| Dyspnea | 8.1 | 8.8 |
| Hypotension | 7.2 | 2.6 |
| Fever | 6.9 | 2.1 |
| Diarrhea | 6.2 | 1.6 |
| Sepsis | 6 | 12.4 |
| Cardiac arrest | 5.8 | 3.1 |
| Nausea | 4.8 | 0.5 |
| Ventricular tachycardia | 4.8 | 3.1 |
| Pain | 4.6 | 3.1 |
| Urinary tract infection | 4.6 | 5.2 |
| Vomiting | 4.2 | 0 |
| Infection | 3.7 | 3.6 |
| Pneumonia | 3.3 | 9.3 |
| Atrial fibrillation | 3 | 11.4 |
| Coughing | 2.8 | 1.6 |
| Abnormal renal function | 2.8 | 4.7 |
| Abdominal pain | 2.6 | 1.6 |
| Cerebrovascular disorder | 2.3 | 4.1 |
| a) Patients may have experienced more than 1 adverse
event. b) with or without thrombosis c) The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel. |
||
Adverse Events In Patients With Or At Risk For HIT Patients Undergoing PCI
The following safety information is based on 91 patients initially treated with argatroban and 21 patients subsequently re-exposed to argatroban for a total of 112 PCIs with argatroban anticoagulation. Adverse events are separated into hemorrhagic (Table 6) and non-hemorrhagic (Table 7) events.
Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease ≥5 g/dL, that led to transfusion of ≥2 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint.
The rate of major bleeding events in patients treated with argatroban in the PCI trials was 1.8%.
Table 6: Major and Minor Hemorrhagic Adverse Events in
Patients With HIT Undergoing PCI
| Major Hemorrhagic Eventsa | |
| Argatroban-treated Patients (n = 112)b % |
|
| Retroperitoneal | 0.9 |
| Gastrointestinal | 0.9 |
| Intracranial | 0 |
| Minor Hemorrhagic Eventsa | |
| Groin (bleeding or hematoma) | 3.6 |
| Gastrointestinal (includes | 2.6 |
| hematemesis) | |
| Genitourinary (includes hematuria) | 1.8 |
| Decrease in hemoglobin and/or hematocrit | 1.8 |
| CABG (coronary arteries) | 1.8 |
| Access site | 0.9 |
| Hemoptysis | 0.9 |
| Other | 0.9 |
| a) Patients may have experienced more than 1 adverse
event. b) 91 patients who underwent 112 interventions. CABG = coronary artery bypass graft |
|
Table 7 gives an overview of the most frequently observed non-hemorrhagic events (>2%), sorted by decreasing frequency of occurrence among argatroban-treated PCI patients.
Table 7 : Non-hemorrhagic Adverse Eventsa in
Patients With HIT Undergoing PCI
| Argatroban Proceduresa (n = 112)b % |
|
| Chest pain | 15.2 |
| Hypotension | 10.7 |
| Back pain | 8 |
| Nausea | 7.1 |
| Vomiting | 6.3 |
| Headache | 5.4 |
| Bradycardia | 4.5 |
| Abdominal pain | 3.6 |
| Fever | 3.6 |
| Myocardial infarction | 3.6 |
| a) Patients may have experienced more than 1 adverse
event. b) 91 patients who underwent 112 interventions. |
|
There were 22 serious adverse events in 17 PCI patients (19.6% in 112 interventions). Table 8 lists the serious adverse events occurring in argatroban-treated-patients with or at risk for HIT undergoing PCI.
Table 8: Serious Advers e Events in Patients With HIT
Undergoing PCIa
| Coded Term | Argatroban Proceduresb (n = 112) |
| Myocardial infarction | 4 (3.5%) |
| Angina Pectoris | 2 (1.8%) |
| Coronary thrombosis | 2 (1.8%) |
| Myocardial Ischemia | 2 (1.8%) |
| Occlusion coronary | 2 (1.8%) |
| Chest pain | 1 (0.9%) |
| Fever | 1 (0.9%) |
| Retroperitoneal hemorrhage | 1 (0.9%) |
| Aortic stenosis | 1 (0.9%) |
| Arterial thrombosis | 1 (0.9%) |
| Gastrointestinal hemorrhage | 1 (0.9%) |
| Gastrointestinal disorder (GERD) | 1 (0.9%) |
| Cerebrovascular disorder | 1 (0.9%) |
| Lung Edema disorder | 1 (0.9%) |
| Vascular disorder | 1 (0.9%) |
| a) Individual events may also have been reported elsewhere
(see Table 6 and 7). b) 91 patients underwent 112 procedures. Some patients may have experienced more than 1 event. |
|
Intracranial Bleeding In Other Populations
Increased risks for intracranial bleeding have been observed in investigational studies of argatroban for other uses. In a study of patients with acute myocardial infarction receiving both argatroban and thrombolytic therapy (streptokinase or tissue plasminogen activator), the overall frequency of intracranial bleeding was 1% (8 out of 810 patients). Intracranial bleeding was not observed in 317 subjects or patients who did not receive concomitant thrombolysis [see DRUG INTERACTIONS].
The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established. Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of 117 patients (4.3%) who received argatroban at 1 to 3 mcg/kg/min and in none of the 54 patients who received placebo. Asymptomatic intracranial hemorrhage occurred in 5 (4.3%) and 2 (3.7%) of the patients, respectively.
Allergic Reactions
One hundred fifty-six allergic reactions or suspected allergic reactions were observed in 1,127 individuals who were treated with argatroban in clinical pharmacology studies or for various clinical indications. About 95% (148/156) of these reactions occurred in patients who concomitantly received thrombolytic therapy (e.g., streptokinase) or contrast media.
Allergic reactions or suspected allergic reactions in populations other than patients with HIT (with or without thrombosis) include (in descending order or frequency):
Limited data are available on the potential formation of drug-related antibodies. Plasma from 12 healthy volunteers treated with argatroban over 6 days showed no evidence of neutralizing antibodies. No loss of anticoagulant activity was noted with repeated administration of argatroban to more than 40 patients.
Read the entire FDA prescribing information for Argatroban (Argatroban Injection)
© Argatroban Patient Information is supplied by Cerner Multum, Inc. and Argatroban Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.