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Monitoring Side Effects

Find the most common side effects of VELCADE.

Contact the doctor if your loved one is experiencing any side effects because they may suggest medications, therapies, or other ways to help relieve or lessen side effects, including changes to your loved one’s treatment plan. Some common side effects associated with VELCADE® (bortezomib) are described below. Please talk to your loved one’s doctor or nurse about the signs and symptoms to be aware of and when to call for advice.

Common Side Effects of VELCADE

Fatigue, malaise, and weakness may be experienced during treatment.

Nausea, diarrhea, constipation, and vomiting are generally mild to moderate. Anorexia or decreased appetite is a condition resulting from the side effects.

Low platelet, neutrophils, and red blood cell counts may temporarily occur during treatment with VELCADE. Platelets are blood cells that help blood to clot, neutrophils are blood cells that help fight infection, and red blood cells are oxygen-carrying cells. Low platelet counts cause an increased risk of bruising and bleeding, and low neutrophil counts cause an increased risk of infection. Both platelets and neutrophils generally return toward their baseline levels during the 10 days between cycles (the rest period). A low red blood cell count is called anemia, which may lead to fatigue and shortness of breath.

Tingling, numbness in the hands, arms, feet, or legs – commonly known as peripheral neuropathy — can progress to discomfort, pain, weakness, or a burning sensation, which in some cases can be severe. These symptoms should be reported to the patient’s doctor or nurse immediately; they can help you and your loved one manage these symptoms. The dose of VELCADE may need to be changed, or treatment interrupted, until the symptoms get better. Should the symptoms improve, the doctor may decide to continue VELCADE at a lower dose. The doctor may also suggest medications or therapies to help relieve or lessen these symptoms.

Even if the symptoms are easy to live with at first, it is important to let the doctor know as soon as the patient experiences any of them or if their existing neuropathy becomes worse. By catching peripheral neuropathy early, the physician may be able to manage it so your loved one can continue on therapy.

Fever may occur after VELCADE is administered, even after your loved one goes home from the doctor visit.

Low blood pressure may also occur during treatment with VELCADE. If the patient experiences a reduction in blood pressure, the doctor may adjust his or her medications or recommend increasing fluid intake. If your loved one has experienced a sudden drop in blood pressure, dizziness, or fainting, he or she should not drive or operate machinery.

Herpes zoster (a painful, itchy rash usually located in an area on one side of the body) may develop while a patient is on VELCADE. In the clinical trials for VELCADE, patients receiving VELCADE demonstrated an increased risk of developing this rash compared to those not on VELCADE. In addition, patients with multiple myeloma are at an increased risk for developing herpes zoster related to their decreased immune system function. The doctor will discuss with you and your loved one the option of taking an antiviral medication to help decrease the risk of him or her developing this condition.

Heart problems. VELCADE treatment can cause or worsen heart rhythm problems and heart failure. Your loved one’s doctor may closely monitor them if they have, or are at risk for, heart disease. Tell their doctor if they experience chest pressure or pain, palpitations, swelling in their hands, ankles, or feet (peripheral edema), or shortness of breath.

Lung disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your loved one’s doctor if they experience any cough, shortness of breath (dyspnea), wheezing, or difficulty breathing.

Liver disease. If your loved one has liver problems, it can be harder for their body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your loved one’s doctor will closely monitor them if they have liver disease.

When Should I Contact the Doctor During Treatment?

You should call the doctor or nurse if you want to discuss any aspect of your loved one’s treatment or have any questions. Be sure to advise the doctor of medications your loved one may be currently taking, including over-the-counter medications and herbal products.

Because they are a trained professional, they can help you and your loved one. Your doctor may prescribe medicines to alleviate or stop the side effect. He or she may decide to lower the dose of VELCADE or instruct your loved one to stop taking VELCADE altogether.

Learn more about side effects.

You should call the doctor if your loved one experiences any of the following:

  • Fever or chills
  • Bruising or bleeding
  • Persistent nausea, vomiting, or diarrhea
  • Shortness of breath or a developing cough
  • Developing jaundice (yellow discoloration of the eyes and skin)
  • Dizziness, light headedness, or fainting spells
  • Reduced eyesight or blurred vision
  • An increase in blood pressure
  • Swelling of their feet, ankles, or legs
  • Changes in blood sugar levels if he or she has diabetes
  • Rash
  • Tingling or numbness of hands or feet

If they are experiencing dizziness, fatigue or fainting spells, they should not drive or operate machinery. If your loved one is vomiting or having diarrhea, they should remember to get plenty of fluids to avoid dehydration. When in doubt about any symptoms they might be experiencing, call the doctor or nurse.


VELCADE Dose Modification

Before starting each VELCADE cycle, the doctor will carefully evaluate blood and urine tests to monitor the effect of the medication on your body. If he or she is having any side effects, it may be necessary to change the dose of VELCADE, temporarily stop his or her treatment, change your infusion schedule, or discontinue VELCADE. In clinical trials, 15 to 25% of patients stopped VELCADE treatment due to side effects.

It is important that you continue your treatment as long as you and your doctor agree that it is in your best interest. Once your prescribed course of therapy is complete, the doctor will discontinue treatment.

NEXT: Talking With Family

Malaise

Feeling of general discomfort, of not feeling well, often indicative of or accompanying the onset of illness

Anorexia

Loss of appetite; may be caused by either the cancer itself or as a side effect of treatments such as chemotherapy

Platelet

A type of blood cell that helps prevent bleeding by causing blood clots to form. Also called a thrombocyte.

Baseline

Starting point; measurement of a medical parameter before the start of treatment to be used as comparison during the treatment and at the end of treatment. For example, the size of a tumor will be measured before treatment (baseline) and then afterwards to see if the treatment had an effect.

Anemia

A low level of red blood cells or hemoglobin; may be characterized by paleness, weakness, or shortness of breath with activity

Peripheral Neuropathy

A condition that occurs due to damage to the peripheral nerves of the arms, hands, legs, and feet. Symptoms include numbness, tingling, pain, itching, and a "pins and needles" sensation. Can also lead to weakness and loss of function

Herpes Zoster

Viral infection of nerves associated with a painful, blistering rash; caused by the same virus that causes chickenpox. After an episode of chickenpox, the virus becomes dormant in the body. Herpes Zoster occurs as a result of the virus re-emerging after many years. Also called shingles.

Clinical Trials

Scientifically controlled study of the safety and effectiveness of a medication (such as a drug or vaccine) using consenting human subjects

Diabetes

A disorder of sugar metabolism caused by a combination of hereditary and environmental factors; characterized by excessive urination, unusually high amounts of sugar in blood and urine, hunger, thirst, and loss of weight

Dehydration

Condition in which the body does not have as much water and fluids as it should. Dehydration can be caused by losing too much fluid, not drinking enough water or fluids, or both. Vomiting and diarrhea are common causes of dehydration


Important Safety Information

What is VELCADE® (bortezomib) used for?

VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of the lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection into your vein (intravenously, or IV) or under your skin (subcutaneously). VELCADE must not be administered into your spinal fluid (intrathecally).

Who should not receive VELCADE?

Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are allergic to bortezomib, boron, or mannitol.

What are the possible side effects of VELCADE?

VELCADE can cause serious side effects, including:

  • Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE, or stop it altogether. If you have peripheral neuropathy before starting VELCADE, your doctor could consider giving you VELCADE subcutaneously.
  • Low blood pressure. VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy, or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.
  • Heart problems. Treatment with VELCADE can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
  • Lung disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing, or difficulty breathing.
  • Liver disease. If you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. In patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
  • Gastrointestinal problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.
  • Neutropenia (low levels of neutrophils, a type of white blood cell) and thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection-fighting cells) and/or platelets (clot-forming cells). You will have regular blood tests to check your cell counts during your treatment with VELCADE. If the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection. If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels, and brain during treatment with VELCADE.
  • Tumor lysis syndrome (TLS). TLS can occur with cancer treatments, and your doctor will be monitoring your blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.
  • Reversible posterior leukoencephalopathy syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain, called RPLS, in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. Treatment with VELCADE should be stopped in cases of RPLS.

More than 30% of patients receiving VELCADE have experienced the following side effects: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (fever), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.

What other information should you discuss with your doctor?

Women should avoid becoming pregnant or breastfeeding while being treated with VELCADE. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.

You should also tell your doctor if you:

  • Have kidney disease. If you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
  • Are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
  • Have liver disease.
  • Are using medicines like ketoconazole (an antifungal), ritonavir (an antiviral), and rifampin (an antibiotic), which will require close monitoring during treatment with VELCADE.
  • Are using any other medications (including over-the-counter drugs), herbal or dietary supplements, or holistic treatments. St. John’s Wort should be avoided.
  • Develop a rash of any type while receiving VELCADE.

The side effects of VELCADE may impair your ability to drive or operate machinery.

These are not all of the possible side effects with VELCADE. It is important to always contact your doctor if you experience any side effects while on VELCADE. If you have any questions about VELCADE, contact your doctor.

Please click here for the full Prescribing Information for VELCADE, including Warnings and Precautions.

Page last updated 1/23/2012

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Important Safety Information
What is VELCADE® (bortezomib) used for?

VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of the lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection into your vein (intravenously, or IV) or under your skin (subcutaneously). VELCADE must not be administered into your spinal fluid (intrathecally).

Who should not receive VELCADE?

Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are allergic to bortezomib, boron, or mannitol.

What are the possible side effects of VELCADE?

VELCADE can cause serious side effects, including:

  • Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE, or stop it altogether. If you have peripheral neuropathy before starting VELCADE, your doctor could consider giving you VELCADE subcutaneously.
  • Low blood pressure. VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy, or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.
  • Heart problems. Treatment with VELCADE can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
  • Lung disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing, or difficulty breathing.
  • Liver disease. If you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. In patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
  • Gastrointestinal problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.
  • Neutropenia (low levels of neutrophils, a type of white blood cell) and thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection-fighting cells) and/or platelets (clot-forming cells). You will have regular blood tests to check your cell counts during your treatment with VELCADE. If the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection. If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels, and brain during treatment with VELCADE.
  • Tumor lysis syndrome (TLS). TLS can occur with cancer treatments, and your doctor will be monitoring your blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.
  • Reversible posterior leukoencephalopathy syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain, called RPLS, in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. Treatment with VELCADE should be stopped in cases of RPLS.

More than 30% of patients receiving VELCADE have experienced the following side effects: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (fever), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.

What other information should you discuss with your doctor?

Women should avoid becoming pregnant or breastfeeding while being treated with VELCADE. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.

You should also tell your doctor if you:

  • Have kidney disease. If you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
  • Are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
  • Have liver disease.
  • Are using medicines like ketoconazole (an antifungal), ritonavir (an antiviral), and rifampin (an antibiotic), which will require close monitoring during treatment with VELCADE.
  • Are using any other medications (including over-the-counter drugs), herbal or dietary supplements, or holistic treatments. St. John’s Wort should be avoided.
  • Develop a rash of any type while receiving VELCADE.

The side effects of VELCADE may impair your ability to drive or operate machinery.

These are not all of the possible side effects with VELCADE. It is important to always contact your doctor if you experience any side effects while on VELCADE. If you have any questions about VELCADE, contact your doctor.

Please click here for the full Prescribing Information for VELCADE, including Warnings and Precautions.