Generic Name: bortezomib (Intravenous route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Proteasome Inhibitor
Bortezomib belongs to the general group of medicines known as antineoplastics or cancer medicines. It is used to treat multiple myeloma in patients with or without a prior history of treatment, and mantle cell lymphoma in patients who have received at least one treatment that has not helped.
Bortezomib interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by bortezomib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.
Bortezomib is to be administered only by or under the supervision of your doctor.
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 bortezomib 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 bortezomib in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
It is very important that your doctor check you at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. You may rise up slowly from sitting or lying position to help prevent lightheadedness or dizziness.
This medicine may cause vomiting and diarrhea, so it is important to drink plenty of fluids. If you experience dizziness or lightheadedness, contact your doctor. These could be symptoms of dehydration (not enough water in your body).
If you are diabetic and you take an oral antidiabetic medicine, you should check your blood sugar level often and report any unusual changes to your doctor.
Make sure your doctor knows if you are pregnant or breastfeeding. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using this medicine to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Tell your doctor right away if you start having numbness, tingling, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. These may be symptoms of a condition called peripheral neuropathy.
Some people who have used this medicine developed serious heart problems. Tell your doctor right away if you have chest pain or discomfort, shortness of breath, irregular heartbeat, or swelling of the feet, ankles, or legs while you are using this medicine.
This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using this medicine and check with your doctor right away if you start having headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using this medicine.
Bortezomib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
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 immediately if any of the following side effects occur:More common
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
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.
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