Argatroban

Argatroban is a prescription medicine used to treat or prevent the symptoms of blood clots in adults (thrombocytopenia) caused by using heparin and in people who are undergoing percutaneous coronary intervention.

• Argatroban is available under the following different brand names: Acova

Adult dosage

Injectable solution

• 100mg/mL

Ready-to-use injectable

• 50mg/50mL 0.9% NaCl
• 125mg/125mL 0.9% NaCl
• 250mg/2.5mL 0.9% NaCl

Thrombocytopenia

Adult dosage

• Initial: 2 mcg/kg/min IV continuous infusion over 1-3 hours until steady-state aPTT is 1.5-3 times initial baseline value  
• Not to exceed infusion rate of 10 mcg/kg/min

Percutaneous Coronary Intervention

Adult dosage

• Initial: 25 mcg/kg/min IV infusion, AND  
• A bolus of 350 mcg/kg IV over 3-5 minutes via a large-bore IV line
• Check activated clotting time (ACT) 5-10 minutes after bolus dose is completed; the procedure may proceed if ACT is more than 300 seconds
• If ACT is less than 300 seconds, administer an additional IV bolus dose of 150 mcg/kg, increase infusion dose to 30 mcg/kg/min, and check ACT 5-10 minutes later
• If ACT more than 450 seconds, decrease infusion rate to 15 mcg/kg/min and check ACT 5-10 minutes later
• After therapeutic ACT (300-450 sec) is achieved, continue this infusion dose for the duration of the procedure

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Argatroban include:

• infection,
• problems with heart function,
• fever,
• nausea,
• vomiting,
• diarrhea,
• low blood pressure,
• shortness of breath,
• headache,
• back pain, and
• chest pain.

Serious side effects of Argatroban include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• easy bruising or bleeding,
• nosebleeds,
• bleeding gums,
• heavy menstrual bleeding,
• unexpected pain or swelling,
• bleeding that will not stop,
• lightheadedness,
• bloody or tarry stools,
• coughing up blood,
• vomiting that looks like coffee grounds,
• pink, red or brown urine,
• slow heart rate,
• weak pulse,
• fainting,
• slow breathing,
• breathing may stop,
• fever,
• flu symptoms,
• mouth and throat ulcers,
• rapid heart rate, and
• shallow breathing.

Rare side effects of Argatroban include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Argatroban has severe interactions with the following drugs:
  • defibrotide
  • mifepristone
  • prothrombin complex concentrate, human
• Argatroban has serious interactions with at least 63 other drugs.
• Argatroban has moderate interactions with at least 121 other drugs.
• Argatroban has minor interactions with the following drugs:
  • acetaminophen
  • acetaminophen IV
  • acetaminophen rectal
  • alprostadil intracavernous/urethral
  • ceftaroline
  • chlorella
  • demeclocycline
  • dexmethylphenidate
  • doxycycline
  • glyburide
  • mineral oil
  • minocycline
  • oxytetracycline
  • quinidine
  • tetracycline
  • verteporfin
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Active major bleeding

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Argatroban?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Argatroban?”

Cautions

• Monitor therapy with aPTT
• Use caution in hepatic impairment; achievement of steady-state aPTT levels may take longer and require more argatroban dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function; avoid the use of high doses in patients undergoing percutaneous coronary intervention (PCI) who have clinically significant hepatic disease
• Patients with illnesses that reduce clearance may require dose reduction
• Safety and efficacy of concomitant administration with thrombolytic agents not established
• Discontinue parenteral anticoagulant therapy before initiating treatment
• Risk of hemorrhage
  • Hemorrhage can occur at any site in the body
  • Intracranial and retroperitoneal hemorrhage reported
  • Unexplained fall in hematocrit or blood pressure after lumbar puncture, spinal anesthesia, major surgery (especially involving the brain, spinal cord, or eye) associated with hemorrhage;
  • Hematologic conditions may increase the risk of hemorrhages, such as congenital or acquired bleeding disorders, and gastrointestinal lesions such as ulcerations
  • Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding

Pregnancy and Lactation

• Limited data from published literature and postmarketing reports do not suggest an association between argatroban and adverse fetal developmental outcomes; there are risks to mothers associated with untreated thrombosis in pregnancy and risk of hemorrhage in mother and fetus associated with the use of anticoagulants
• Pregnancy confers an increased risk for thromboembolism that is higher for women with the underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy
• Use of anticoagulants, including argatroban, may increase the risk of bleeding in fetus and neonate; monitor neonates for bleeding
• Pregnant women should be carefully monitored for evidence of excessive bleeding or unexpected changes in coagulation parameters during labor or delivery
• Lactation
  • There are no data on presence in human milk or effects on milk production; it is present in rat milk; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition