Bivalirudin is used in conjunction with aspirin to decrease the ability of the blood to clot and prevent any potentially dangerous clots form in the blood vessel. It is used in patients who are experiencing certain blood vessel and heart procedures, such as coronary angioplasty (open blocked arteries). Bivalirudin is only available with a valid prescription from your doctor and is available in a 'powder for solution' form via injection.
As with all medications, there can be a variety of unwanted side effects not related to the treatment of the illness in question. Most side effects are harmless, but if they are persistent or develop into further problems then you should always seek urgent medical attention. You can report any side effects to the FDA on 1-800-FDA-1088.
Below we've listed side effects in terms of common, less common and rare.
Check with your doctor or nurse immediately if any of the following side effects occur:
As mentioned above, some side effects may occur that usually do not require urgent medical attention. You may find that these side effects disappear as your body adjusts to the medicine during treatment. If you find the side effects are affecting your day-to-day life or mood then you should contact your doctor or local health care professional for tips on ways to prevent or reduce the intensity of the side effects. If you find you have any of the below side effects, check with your health care professional if they continue and become bothersome, or if you have any questions or queries.
Bivalirudin is injected into a vein via an IV injection. This will be given in a hospital or clinical setting by a trained professional. When used for angioplasty procedure the medicine must be given throughout the entire procedure. Your doctor may recommend you continue to receive Bivalirudin for up to 20 hours after your angioplasty procedure. Bivalirudin is usually given in conjunction with aspirin.
The final dosage of any medication is dependent on a number of factors including, the treatment Bivalirudin is being used for, your age, height, weight, allergic reactions and your past medical history including family history.
Angiomax is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.
As a guide, the dose that is recommended of Bivalirudin (Angiomax) for patients who don't have HIT/HITTS is an IV (intravenous) bolus dose of 0.75 mg/kg, followed immediately by an 1.75 mg/kg/h infusion for the duration of the procedure. An activated clotting time should be performed five minutes after the bolus dose has been given and if required, an additional 0.3 mg/kg should be given.
For those patients who do have HIT/HITTS, the dose that is recommended of Angiomax is for those undergoing PCTA/PCI is an IV (intravenous) bolus of 0.75 mg/kg. This should again also be followed up immediately with a continuous infusion at a rate of 1.75 mg/kg/h for the full length of the procedure.
For injection: 250 mg of bivalirudin is given in a single-dose vial for reconstitution. Each of the vials contains 250 mg of bivalirudin which is equivalent to an approximate average of 275 mg bivalirudin trifluoroacetate. Once the reconstruction with sterile water for injection has proceeded, the product will be an opalescent/clear, colorless/slight yellow solution with a PH of 5-6.
Since this medication is given in a clinical setting by trained professionals, it is unlikely that you will overdose or miss a dose.
Different medications can interact negatively with other medications. It is therefore important that you inform your doctor/physician of absolutely everything you are currently taking, including herbal remedies. It is also important that you give a full medical history background of previous illnesses or illnesses that run in the family.
Tell your doctor if you are taking any medications to treat or prevent blood clots, such as:
There are up to 45 drugs known to have a major interaction with Bivalirudin; some are listed below. This list is not complete, so it is therefore vital that you speak to your doctor about all the current medication you are on or have been on in the past.
Below are various warnings in place you should consider before taking Bivalirudin.
It is extremely important that you visit your doctor regularly after you leave the hospital to catch any unwanted effects or problems that may occur due to the medicine. Be sure to turn up to all appointments to minimise your risk.
Bivalirudin can increase your chance of bleeding. Check with your doctor immediately if you notice any bruising or unusual bleeding or bruising; tarry, black stools; blood in the urine or stools; or any pinpoint red spots on your skin. Try to avoid picking at your nose and if you need to blow your nose, then do so gently.
It has be shown that there is an increase in the risk of a thrombus formation which can include a fatal outcome, when using Angiomax during gamma brachytherapy.
You should not take Angiomax if you currently experience active major bleeding or experience hypersensitivities such as anaphylaxis towards Bivalirudin or its similar components.
It is not known whether Bivalirudin is passed in human milk during breastfeeding. Because many drugs can normally be excreted in human milk, you should exercise some caution when Angiomax is administered to a woman who is breastfeeding.
Bivalirudin is under FDA pregnancy category B which means Bivalirudin is not expected to harm an unborn baby. However, aspirin is usually intended in conjunction with Bivalirudin, and aspirin can cause bleeding when it is taken during the third trimester of pregnancy. Aspirin can also cause side effects in a newborn baby. Angiomax and aspirin should be used together during pregnancy only if completely necessary. Inform your doctor if you are pregnant or are planning on getting pregnant in the near future.
Whilst taking Bivalirudin you should avoid activities that could increase your risk of injury or bleeding and use extra caution and care to prevent bleeding while brushing your teeth or shaving. You should also avoid drinking alcohol completely as it can increase the risk of bleeding in your intestines or stomach.
You should not receive bivalirudin if you are allergic to bivalirudin, or if you have any major bleeding from an injury, surgery, or other medical trauma.
To ensure Bivalirudin is safe for you to take you should inform your doctor or health care professional if you have kidney disease, heart disease or a blood clotting or bleeding disorder such as hemophilia.
Thos with retinal (eye problems) should note that the disposition of Angiomax was studied in PTCA patients with moderate, severe and mild renal impairment. The clearance of Angiomax was reduced by around 20% in patients with severe and moderate renal impairment and was reduced approximately 80% in dialysis-dependent patients. This means the infusion dose of Angiomax may need to be reduced in patients with retinal impairment. Inform your doctor if you have any eye-related problems or there is a family history of assosiated problems.
Since Bivalidrudin is given in a secure medical setting such as professional clinic or hospital, you will not need to store the medicine yourself at home. The general guidelines for storage of Bivalirudin within a clinical setting are as follows.
Do not freeze diluted or reconstituted Angiomax. The reconstituted material may be stored at 2-8°C for up to twenty-four hours. Diluted Angiomax with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to twenty-four hours. Ensure that you discard any unused portion of reconstituted solution remaining in the vial.
Bivalirudin, when taken correctly in a secure setting, is highly successful in preventing the formation of dangerous blood clots. Dangerous situations arise when the correct information is not given to your healthcare professionals about what type of medication you are taken, regardless of whether it is herbal or not, or your full family history of bleeding and blot clot related disorders. As a guide, it isn't recommended in pregnancy due to the use of aspirin alongside and should only be used as a completely last resort. The safety and effectiveness of Angiomax in paediatric patients have not been established. Bivalirudin can also be obtained with a prescription from your doctor or qualified health professional. Bivalirudin may also be used for purposes not listed in this medication guide. Because Bivalirudin keeps your blood from clotting to prevent unwanted blood clots, it can be easier for you to bleed even from a minor injury such as cutting yourself or bleeding gums, it's therefore important you take extra care when participating in daily tasks. Contact your doctor immediately or seek emergency medical attention if you have bleeding that will not stop despite attempts. If you follow all these precautions and guidelines, you should have no issue with receiving Bivalirudin.