Acova

Name: Acova

What Is Argatroban?

Argatroban helps to prevent platelets in your blood from sticking together and forming a blood clot.

Argatroban is used to treat or prevent blood clots in people who have thrombocytopenia (low levels of platelets in the blood) caused by using heparin. Argatroban is sometimes used in people who are undergoing a procedure called angioplasty (to open blocked arteries).

Argatroban may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have any major bleeding from a surgery, injury, or other medical trauma.

Tell your doctor if you are using or receiving blood thinners or any other medications used to treat or prevent blood clots.

Argatroban can make it easier for you to bleed, even from a minor injury.

You should not receive this medicine if you are allergic to argatroban, or if you have any major bleeding from a surgery, injury, or other medical trauma.

To make sure argatroban is safe for you, tell your doctor if you have:

  • a stomach ulcer or bleeding;
  • liver disease;
  • a bleeding or blood clotting disorder (such as hemophilia);
  • untreated or uncontrolled high blood pressure (hypertension);
  • if you have recently had a spinal tap or epidural anesthesia; or
  • if you have recently had major surgery (especially eye surgery, brain surgery, or spinal cord surgery).

Argatroban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with argatroban, and taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant while taking aspirin.

It is not known whether argatroban passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Argatroban Side Effects

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 a serious side effect such as:

  • a light-headed feeling, like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • any bleeding that will not stop;
  • pain or burning when you urinate;
  • sudden numbness or weakness, problems with vision, speech, or balance;
  • sudden severe headache, confusion, sudden changes in your senses of taste or touch;
  • fever, chills, body aches, flu symptoms;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • slow heart rate, weak pulse, slow breathing (breathing may stop); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • headache;
  • back pain; or
  • bleeding around the IV needle.

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.

Argatroban Interactions

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines.

Tell your doctor about all other medications you use or have recently received to prevent blood clots, such as:

  • a blood thinner such as heparin or warfarin (Coumadin, Jantoven);
  • abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat);
  • dabigatran (Pradaxa), bivalirudin (Angiomax), lepirudin (Refludan);
  • dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or
  • alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).

This list is not complete. Other drugs may interact with argatroban, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is the most important information I should know about Acova (argatroban)?

You should not use this medicine if you have any major bleeding from a surgery, injury, or other medical trauma.

Tell your doctor if you are using or receiving blood thinners or any other medications used to treat or prevent blood clots.

Argatroban can make it easier for you to bleed, even from a minor injury.

Acova (argatroban) side effects

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 a serious side effect such as:

  • a light-headed feeling, like you might pass out;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • blood in your urine;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • any bleeding that will not stop;

  • pain or burning when you urinate;

  • sudden numbness or weakness, problems with vision, speech, or balance;

  • sudden severe headache, confusion, sudden changes in your senses of taste or touch;

  • fever, chills, body aches, flu symptoms;

  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

  • slow heart rate, weak pulse, slow breathing (breathing may stop); or

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;

  • headache;

  • back pain; or

  • bleeding around the IV needle.

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.

Patient Handout

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For the Consumer

Applies to argatroban: intravenous solution

Along with its needed effects, argatroban (the active ingredient contained in Acova) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking argatroban:

More common
  • Bleeding from the bladder
  • blood in the urine
  • blurred vision
  • chest pain
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fever
  • no blood pressure or pulse
  • stopping of heart
  • sweating
  • unconsciousness
  • unusual tiredness or weakness
Less common
  • Arm, back, or jaw pain
  • bloody or black, tarry stools
  • chest tightness or heaviness
  • constipation
  • cough or hoarseness
  • coughing or spitting up blood
  • fast, slow, or irregular heartbeat
  • fast, pounding, or irregular heartbeat or pulse
  • lower back or side pain
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • palpitations
  • severe stomach pain
  • shortness of breath
  • sweating
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
Rare
  • Abdominal pain or swelling
  • back pain or backaches
  • blue lips and fingernails
  • changes in skin color
  • cold hands and feet
  • coughing that sometimes produces a pink frothy sputum
  • diarrhea
  • difficult, fast, noisy breathing, sometimes with wheezing
  • increased sweating
  • indigestion
  • loss of appetite
  • pain, redness, or swelling in the arm or leg
  • pains in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • passing of gas
  • severe headaches of sudden onset
  • stomach pain, fullness, or discomfort
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • swelling in the legs and ankles

Usual Adult Dose for Thrombotic/Thromboembolic Disorder

Heparin-induced thrombocytopenic (HIT) thrombosis treatment or prophylaxis:
Initial: 2 mcg/kg/min administered as a constant infusion. Begin infusion only after obtaining a baseline activated partial thromboplastin time (aPTT).
Maintenance: The infusion rate may be adjusted as needed (not to exceed 10 mcg/kg/min) until the steady state aPTT value is 1.5 to 3 times the initial baseline value (not to exceed 100 seconds). Dosage adjustments should be based on aPTT results from blood samples obtained at least 2 hours after the most recent infusion rate change.

Percutaneous Coronary Interventions (PCI) in HIT/HITTS patients:
Initial: 25 mcg/kg/min infusion and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. Activated clotting time (ACT) should be checked 5 to 10 minutes after the bolus dose is completed. The procedure may proceed if the ACT is greater than 300 seconds.
If the ACT is less than 300 seconds, an additional IV bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later. If the ACT is greater than 450 seconds, the infusion rate should be decreased to 15 mcg/kg/min, and the ACT checked 5 to 10 minutes later. Once a therapeutic ACT (between 300 and 450 seconds) has been achieved, this infusion dose should be continued for the duration of the procedure.

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