Posted on December 3rd, 2008 by
Generic Name: Bortezomib (bore-TE-zo-mib)
Trade Name: Velcade®
For which conditions is this drug approved? Bortezomib is FDA approved for the treatment of multiple myeloma and mantle cell lymphoma in patients who have received at least one prior therapy. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Bortezomib is classified as a proteosome inhibitor. Bortezomib produces its anti-cancer responses by inhibiting proteosome complexes in a cell. Proteosome complexes have many different functions in a cell, including growth and death pathways of many different proteins. Inhibition of proteosome complexes ultimately causes cellular death.
How is bortezomib typically given (administered)? Bortezomib is given intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with bortezomib. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with bortezomib?
• Low red blood cell levels – increases risk for anemia and transfusions
• Low platelet levels – increases risk for bleeding
• Numbness or tingling of hands and feet
• Nausea and vomiting
• Loss of appetite
What are the less common (occur in 10% to 29% of patients) side effects of treatment with bortezomib?
• Low white blood cell levels – increases risk for infection
• Abnormalities in electrolytes – as determined by blood tests??
• Joint pain, muscle pain
• Muscle cramps
• Bone pain
• Back or limb pain
• Abdominal pain
• Retention of fluid resulting in swelling of the hands, feet, legs or face
• Difficulty breathing
• Vision abnormalities
• Reduced blood pressure
• Difficulty sleeping
• Respiratory infection
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should inform their physician if they are taking medication to treat blood pressure.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should inform their physician if they have had a reaction to boron or manitol.
• Bortezomib may cause loss of sensation of the fingers or toes. Patients should use caution when around extreme heat or cold, as they may not feel burns or frostbite occur.
• Bortezomib may cause fatigue, dizziness, fainting, or vision abnormalities. Patients should use caution when driving or operating machinery.
When should patients notify their physician?
• Increasing numbness or pain of the fingers or toes
• Difficulty breathing
• Increasing or persistent dizziness
• Lightheadedness of fainting spells
• Flu-like symptoms
• Sore throat
• Unexplained bleeding (nosebleeds, bruising, blood in urine, black tarry stools, etc.)
• Persistent nausea and vomiting
• Persistent diarrhea
• Persistent constipation
• Muscle cramps
• Abdominal cramps
• Swelling of the feet, legs, hands or face
• Severe fatigue and weakness
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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