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Side Effects of VELCADE® (bortezomib)

You may have side effects during treatment with VELCADE. It is very important that you contact your doctor if you think you might be experiencing any side effects or anything else out of the ordinary.

Some side effects associated with VELCADE are described below.

VELCADE can cause serious side effects, including:

Neutropenia and leukopenia (low levels of neutrophils and leukocytes, types of white blood cells) and thrombocytopenia (low levels of platelets)

Neutropenia and leukopenia (low levels of neutrophils and leukocytes, types of white blood cells) 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. Both platelets and neutrophils generally return toward their baseline levels during the 10-day rest period that is built into the treatment schedule for 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 for bruising and bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels, and brain during treatment with VELCADE.

Gastrointestinal problems (nausea, diarrhea, constipation, and vomiting)

Gastrointestinal problems (nausea, diarrhea, constipation, and vomiting) are generally mild to moderate and can often be managed with appropriate medications. Sometimes, however, they can be more serious. If you experience these symptoms, ask your doctor about medications that can be taken before your next dose of VELCADE that may help prevent these side effects from occurring.

Hypotension (low blood pressure)

Hypotension (low blood pressure). VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy, feel as though you might faint, or feel light-headed upon rising. 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. If you experience dizziness or fainting, you should not drive or operate machinery.

Peripheral neuropathy (tingling, numbness in the hands, arms, feet, or legs)

Peripheral neuropathy (tingling, numbness in the hands, arms, feet, or legs) can progress to discomfort, pain, muscle weakness, or a burning sensation, which in some cases can be severe. These symptoms should be immediately reported to your doctor or nurse, who will help you manage them. If you develop peripheral neuropathy, your dose of VELCADE may need to be lowered, your treatment interrupted until your symptoms get better, or VELCADE may be discontinued altogether. Should your symptoms improve, your doctor may decide to continue VELCADE at a lower dose. Your doctor may also suggest medications or therapies to relieve or lessen these symptoms.

Heart problems

Heart problems. VELCADE treatment 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 in your hands, ankles, or feet (peripheral edema), or shortness of breath.

Lung disorders

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 (dyspnea), wheezing, or difficulty breathing.

Liver disease

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.

Tumor Lysis Syndrome (TLS)

Tumor Lysis Syndrome (TLS). TLS can occur with cancer treatments and your doctor will be monitoring 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)

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. VELCADE treatment should be stopped in cases of RPLS.


NEXT: Other Side Effects

Other side effects associated with VELCADE® (bortezomib) are described below. Remember, please talk to your doctor or nurse about the signs and symptoms to be aware of and contact your doctor if you experience any side effects or anything out of the ordinary.

Asthenia (fatigue, malaise, and weakness)

Asthenia (fatigue, malaise, and weakness) may be experienced during treatment. Make sure you get plenty of rest, maintain good nutrition, and stay well hydrated to help minimize fatigue. Also, trying to maintain some daily activity can be helpful. Make sure you talk to your doctor or nurse about ways to help manage your fatigue and how much activity is right for you.

Anemia (a low level of red blood cells)

Anemia (a low level of red blood cells) may temporarily occur during treatment with VELCADE. Red blood cells are oxygen-carrying cells. A low red blood cell count may lead to symptoms such as fatigue and shortness of breath. Your doctor may decide to treat your anemia with medication or a blood transfusion.

Anorexia (decreased appetite)

Anorexia (decreased appetite) is a condition resulting from the possible gastrointestinal side effects of VELCADE described previously (nausea, diarrhea, constipation, and vomiting). Increasing your fluid intake is recommended to prevent dehydration. Eating small frequent meals may help.

Pyrexia (fever)

Pyrexia (fever) may occur after VELCADE is administered. Ask your doctor for guidance on when to seek medical help.

Herpes zoster (a painful, itchy rash usually located in an area on one side of the body)

Herpes zoster (a painful, itchy rash usually located in an area on one side of the body) may develop while you are taking VELCADE. In addition, patients with multiple myeloma are at an increased risk for developing herpes zoster related to their decreased immune system function. Your doctor will discuss with you the option of taking an antiviral medication to help decrease your risk of developing this condition.

Additional side effects

Additional side effects that have been seen with VELCADE include insomnia (trouble sleeping) and headache.


NEXT: When to Contact My Doctor

You should call your doctor or nurse if you want to discuss any aspect of your treatment or if you have any questions. Be sure to advise your doctor of medications you may be currently taking, including over-the-counter medications and herbal products. It is also important to advise your doctor of any new or ongoing health concerns you may have.

Call your doctor or nurse immediately if you think you may be having a side effect. Your doctor may prescribe medicines to help minimize or even avoid the side effect. He or she may decide to lower your dose of VELCADE. In some cases it may become necessary to discontinue VELCADE altogether.

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 anti?fungal) and ritonavir (an antiviral), 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.
  • develop a rash of any type while receiving VELCADE.

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


NEXT: What to Expect: Treatment With VELCADE

Kidney

One of a pair of bean-shaped organs that remove waste from the blood in the form of urine; located near the spine, towards the lower back of the abdomen

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

Dialysis

The process of cleansing the blood to remove toxic material when the kidneys are unable to perform their function properly

Glucose

A type of sugar, the chief source of energy for living organisms


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

Will VELCADE by covered by my insurance?
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.