Pronunciation:

ar-GAT-roe-ban

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Thrombin Inhibitor, Direct

Uses of This Medicine:

Argatroban is used to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels. This medicine is used to treat or prevent blood clots in patients with bleeding problems caused by another medicine called heparin. It may also be used in patients who are having certain heart and blood vessel procedures, such as coronary angioplasty.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of argatroban in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of argatroban in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require an adjustment of dosage in patients receiving argatroban.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Celecoxib
• Choline Salicylate
• Cilostazol
• Citalopram
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Omadacycline
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Sarecycline
• Selexipag
• Sertraline
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Vitamin A
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding, active—Should not be used in patients with this condition.

• Blood disease or bleeding problems or
• High blood pressure, severe or
• Major surgery (e.g., eye, brain, or spine surgery) or
• Spinal anesthesia or lumbar puncture or
• Stomach or intestinal ulcer—Use with caution. The risk of bleeding may be increased.

• Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

This medicine will only be given to you while you are in the hospital. Before you leave the hospital, you may be switched to an oral medicine that works in a similar way. If you have any concerns about this, talk to your doctor.

It is very important that your doctor check you at regular visits after you leave the hospital for any problems or unwanted effects that may be caused by this medicine. Be sure to keep all appointments.

This medicine may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.