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Bortezomib

(bor-tez-uh-mib)

Trade/other name(s): Velcade

Why would this drug be used?

This drug is used to treat certain cancers of the blood and bone marrow cancers, such as multiple myeloma and mantle cell lymphoma. It is being studied for use against other cancers as well.

How does this drug work?

Bortezomib is a type of targeted therapy known as a proteasome inhibitor. Proteasomes are part of the machinery found in all cells in the body. They normally help control the levels of certain proteins that are important for cell growth and survival. Bortezomib interferes with this process, resulting in cell death. Cancer cells are more prone to this damage than are normal cells.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have diabetes. This drug may affect blood glucose levels. You and your doctor may need to watch your glucose levels closely while you are getting this drug.
  • If you take any blood pressure medicines or have ever fainted in the past. This drug may lower your blood pressure, which could be dangerous if it is already affected by other medicines.
  • If you have numbness, tingling, or pain in your hands or feet. This drug can damage nerves and make the problem worse.
  • If you have any type of liver disease (including hepatitis). This drug is cleared from the body mainly by the liver. Reduced liver function might result in more drug than expected staying in the body, which could lead to unwanted side effects. Your doctor may need to adjust your dose accordingly.
  • If you have heart disease or congestive heart failure, or if you are at high risk of heart disease. In rare cases this drug may affect heart function.
  • If you have any other medical conditions such as kidney disease, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause problems with the fetus if taken at the time of conception or during pregnancy. Check with your doctor about what kinds of birth control can be used with this medicine. In pregnant women, treatment with this drug should be continued only if the potential benefit to the mother outweighs the risk to the fetus.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • If you think you might want to have children in the future. This drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Some drugs or supplements might either raise or lower the level of bortezomib in your blood. The following drugs can also cause bortezomib to build up in the body, raising the risk of serious side effects:

  • the antidepressant nefazodone (Serzone)
  • the antibiotics clarithromycin (Biaxin) and telithromycin (Ketek)
  • anti-fungal antibiotics such as ketoconazole (Nizoral) and itraconazole (Sporanox)
  • HIV drugs such as indinavir, ritonavir, nelfinavir, saquinavir, and others

Do not start or stop taking these medicines while on bortezomib without talking with the prescribing doctor(s) about all of the medicines you take, including bortezomib.

These drugs and supplements can lower the levels of bortezomib in the blood and make it less effective:

  • anti-seizure drugs carbamazepine (Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin)
  • TB drugs rifampin (Rifadin, Rimactane; also in Rifamate and Rifater), and rifabutin (Mycobutin)
  • the steroid drug dexamethasone (Decadron)
  • St. John's wort (herbal dietary supplement)

If you need to take these drugs, your doctor may need to adjust your dose of bortezomib.

Bortezomib may increase the risk of peripheral neuropathy (tingling, burning, numbness, or pain in the hands and feet) if used along with amiodarone, isoniazid, nitrofurantoin, antiviral drugs, or "statin" cholesterol-lowering drugs (simvastatin, atorvastatin, etc.).

Bortezomib may lower your blood pressure, which could be a problem if you are already taking any blood pressure medicines.

If you are taking pills for your diabetes, this treatment may make your blood sugar vary in different ways. You will need to check your blood sugar more often while on this drug.

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with bortezomib. These include:

  • vitamin E
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • warfarin (Coumadin)
  • ticlopidine (Ticlid)
  • clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

There may be more drugs that interact with bortezomib. Check with your doctor, nurse, or pharmacist about any other medicines, herbs, and supplements you are taking, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Bortezomib can be given as an injection into a vein (IV) over a few seconds or as an injection under the skin (subcutaneously, or SQ). It is given twice a week to start (with doses at least 72 hours apart) for 2 to 4 weeks, sometimes followed by a rest period. The schedule may be once or twice a week after that. The dose is based on your weight and height, and the illness that is being treated. The dose may need to be changed if you have certain side effects.

Precautions

Bortezomib may cause tiredness, dizziness, blurred vision, or double vision. It can also cause a quick drop in blood pressure when you go from lying down to sitting up, or from sitting to standing up (orthostatic hypotension), which can make you feel dizzy or even faint. Your doctor will probably advise you to drink plenty of liquids during your treatment. Do not drive or operate heavy machinery until you find out how this medicine affects you.

You may have nausea and vomiting on the day you receive this drug or in the first few days afterward. Your doctor may give you medicine before your treatment to help prevent nausea and vomiting. You will likely also get a prescription for an anti-nausea medicine that you can take at home. It is important to have these medicines on hand and to take them as prescribed by your doctor. Tell the doctor if the medicines do not control your vomiting.

This drug may cause serious diarrhea. If left unchecked, this could lead to dehydration and chemical imbalances in the body. Your doctor may advise you to drink plenty of fluids and may prescribe medicine to help prevent or control this side effect. It is very important that you take this medicine as prescribed. Make sure you get the medicine right away, so that you will have it at home when you need it. Tell your doctor if the medicine doesn't control your diarrhea.

This drug may cause damage to certain nerves in the body, which can lead to a condition called peripheral neuropathy. This can cause numbness, weakness, pain, or sensations of burning or tingling, usually in the hands or feet. These symptoms can sometimes progress to include sensitivity to cold or trouble walking or holding things in your hands. Let your doctor know right away if you notice any of these problems. If your symptoms are severe enough, this drug may need to be stopped or the dose reduced until they get better.

Your doctor will probably test your blood throughout your treatment, looking for possible effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Be sure to keep all your appointments for lab tests and doctor visits.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, a new cough, or bringing up sputum.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. Bortezomib may affect your immune system. This could make vaccinations ineffective, or even lead to serious infections if you get a live virus vaccine during or soon after treatment. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

This drug can cause the rapid killing of tumor cells, which in some cases has led to serious kidney damage within the first 24 hours of treatment (a condition known as tumor lysis syndrome). This is more likely if you have a very large number of cancer cells in the body. If your doctor feels you might be at risk, he or she will give you medicines and/or fluids to help prevent this.

In rare cases, patients have developed severe lung disease during treatment. Tell your doctor right away if you notice any possible symptoms of lung problems, such as shortness of breath or a new cough.

In rare cases, this drug may affect the brain in what is known as reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms of RPLS might include seizures, high blood pressure, headache, trouble concentrating, confusion, changes in vision, blindness or other problems. Tell your doctor right away if you notice any of these symptoms. Symptoms usually go away once this medicine is stopped.

Avoid pregnancy during and for some months after treatment, since exposure to this drug may harm the fetus. Talk with your doctor about this.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • tiredness or fatigue*
  • weakness
  • nausea or vomiting*
  • diarrhea*
  • constipation
  • new or worsening numbness or tingling in the hands or feet (peripheral neuropathy)*

Less common

  • poor appetite
  • low platelet count with risk for bleeding*
  • low white blood count with risk for infection*
  • low red blood cell count*
  • low blood pressure (may cause you to feel dizzy or faint, especially when changing positions)*
  • fever
  • blurred vision
  • dizziness
  • headache
  • cough
  • shortness of breath
  • rash
  • swelling in the hands or feet
  • trouble sleeping
  • anxiety or agitation
  • confusion*
  • redness or irritation at injection site

Rare

  • damage to the heart muscle (can cause heart failure with symptoms like shortness of breath or swelling in the hands or feet)
  • damage to the lungs*
  • changes in the brain that can cause headache, confusion, seizures, or blindness*
  • allergic reaction with symptoms like itching; skin welts; swelling of mouth, face or throat; trouble breathing or swallowing; dizziness or faintness
  • imbalance in blood chemistry (electrolytes)
  • pneumonia or other infection
  • bleeding in the bowel
  • bleeding in the brain
  • liver failure, which may improve after the drug is stopped
  • death due to heart problems, lung complications, or other cause

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2003

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 02/26/2010
Last Revised: 01/24/2012