Pronunciation:

bye-VAL-i-roo-din

Brand Names:

• Angiomax

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Thrombin Inhibitor, Direct

Chemical—

Hirudin Related

Uses of This Medicine:

Bivalirudin is used together with aspirin to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels. It is 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 bivalirudin 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 bivalirudin in the elderly. However, elderly patients are more likely to have bleeding problems than younger adults, which may require caution in patients receiving bivalirudin.

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
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Celecoxib
• Chamomile
• 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
• Garlic
• Ginkgo
• 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
• Papaya
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Sarecycline
• Selexipag
• Sertraline
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tan-Shen
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

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.

• Chondroitin
• Coenzyme Q10
• Dong Quai
• Ginger
• Vitamin A

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.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado

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

• Brachytherapy (a radiation treatment)—Use with caution. Your chance of having blot clots may be increased.

• Kidney disease—Use with caution. May require an adjustment of dosage for patients with this condition.

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:

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.

Bivalirudin 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

Abdominal pain or swelling

arm, back, or jaw pain

black, tarry stools

blood in the eyes

blood in the urine

blurred vision

bruising or purple areas on the skin

chest pain or discomfort

chest tightness or heaviness

confusion

coughing up blood

decreased alertness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

headache

joint pain or swelling

nausea

nervousness

nosebleeds

pounding in the ears

shortness of breath

slow, fast, or irregular heartbeat

sweating

unusual tiredness or weakness

Less common

Decrease in frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

lightheadedness or fainting

painful urination

Rare

Blue lips and fingernails

changes in skin color

cold hands and feet

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

difficult, fast, noisy breathing, sometimes with wheezing

fever or chills

increased blood pressure

increased thirst

loss of appetite

lower back or side pain

pain, redness, or swelling in the arm or leg

pale skin

paralysis of the face

rapid, shallow breathing

severe numbness, especially on one side of the face or body

swelling in the legs and ankles

swelling of the face, fingers, or lower legs

troubled breathing

vomiting

weight gain

Incidence not known

Bleeding gums

difficulty in swallowing

hives

increased menstrual flow or vaginal bleeding

irritation

itching

joint stiffness

pains in the chest, groin, or legs, especially calves of legs

paralysis

prolonged bleeding from cuts

rash

red or dark brown urine

redness of the skin

severe headaches of sudden onset

sudden loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sudden vision changes

swelling of the eyelids, lips, hands, or feet

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Fear or nervousness

pain where the needle is placed

pelvic pain

sleeplessness

trouble sleeping

unable to sleep

Less common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort, upset, or pain

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.