Bivalirudin (Intravenous route)
- Powder for Solution
Thrombin Inhibitor, Direct
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:
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.
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.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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.
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amtolmetin Guacil
- Choline Salicylate
- Collagenase, Clostridium histolyticum
- Dabigatran Etexilate
- Drotrecogin Alfa
- Fenofibric Acid
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Pentosan Polysulfate Sodium
- Reteplase, Recombinant
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
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.
- Coenzyme Q10
- Dong Quai
- Vitamin A
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.
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:
- 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
- coughing up blood
- decreased alertness
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- joint pain or swelling
- pounding in the ears
- shortness of breath
- slow, fast, or irregular heartbeat
- 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
- 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
- weight gain
- Incidence not known
- Bleeding gums
- difficulty in swallowing
- increased menstrual flow or vaginal bleeding
- joint stiffness
- pains in the chest, groin, or legs, especially calves of legs
- prolonged bleeding from cuts
- 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
- More common
- Fear or nervousness
- pain where the needle is placed
- pelvic pain
- trouble sleeping
- unable to sleep
- Less common
- Acid or sour stomach
- stomach discomfort, upset, or pain
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:
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:
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.
Last Updated: 10/12/2016