Possible side effects of treatment with VELCADE® (bortezomib)

It is important to know the possible side effects of any medication you're taking. They can vary by type, frequency, and severity.

If you think you might be having side effects, it is important to contact your healthcare team. Some side effects related to treatment with VELCADE® (bortezomib) are described below.

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

Peripheral neuropathy (tingling or numbness in the hands, arms, feet, or legs), which may be caused by your treatment, can progress to discomfort, pain, muscle weakness, or a burning sensation. In some cases, it can be severe.

  • These symptoms should be immediately reported to your doctor or nurse, who may be able to help you manage them.
  • Your doctor may lower your dose of VELCADE (bortezomib), interrupt your treatment until your symptoms get better, or stop your treatment with VELCADE.
  • Should your symptoms improve, your doctor may decide to continue VELCADE at a lower dose.
  • Your doctor may also suggest medicines or therapies to relieve or lessen these symptoms.
  • If you already have peripheral neuropathy before treatment or if you believe you may be at high risk for peripheral neuropathy, your doctor may prescribe subcutaneous VELCADE (VELCADE given as a shot). Consider asking your doctor about this option.

A clinical trial showed differences in occurrence of peripheral neuropathy between patients treated with intravenous VELCADE and those treated with subcutaneous VELCADE. This trial included 222 relapsed patients who had been previously treated for multiple myeloma.

In this study:

  • The rates of peripheral neuropathy were 37% with subcutaneous VELCADE compared to 50% with VELCADE given intravenously for all levels of severity.
  • For more severe cases, the rates were 6% with subcutaneous VELCADE compared to 15% of patients who received intravenous VELCADE.

If you have pre-existing or are at high risk for peripheral neuropathy:

  • Ask your healthcare team about the possibility of taking VELCADE subcutaneously.
  • Apply cream or lotion to soothe your hands and feet.
  • Avoid tight, uncomfortable shoes.
  • Wear gloves when washing dishes.
  • Use insulated potholders.

Hypotension (low blood pressure)

VELCADE (bortezomib) can cause a drop in blood pressure. Tell your doctor if you have low blood pressure. Also mention if you 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 healthcare team may need to give you fluids by IV. If you have dizziness or fainting, don’t drive or operate machinery.

Heart problems

Treatment with VELCADE (bortezomib) can cause heart rhythm problems and heart failure, or make them worse. Your healthcare team may closely monitor you if you have heart disease or are at risk for it. Tell your healthcare team if you have chest pressure or pain; palpitations (rapid heartbeat); swelling in your hands, ankles, or feet; or shortness of breath.

Lung disorders or problems

There have been reports of lung disorders in patients receiving VELCADE (bortezomib). Some of these events have been fatal. Tell your healthcare team if you have any cough, shortness of breath, wheezing, or difficulty breathing.

Liver disease or problems

If you have liver problems, it can be harder for your body to process VELCADE (bortezomib). VELCADE has caused sudden liver failure in patients who were taking many medications or who had other serious medical conditions. Symptoms of liver problems include a yellow color to eyes and skin (jaundice) and changes in liver enzymes (measured with blood tests).

Your healthcare team will closely monitor you if you have liver disease. In patients who have moderate or severe liver disease, VELCADE should be started at a lower dose. More dose adjustments may be made based on tolerance to the drug.

Posterior Reversible Encephalopathy Syndrome (PRES)

There have been reports of a rare condition (called PRES) involving the brain in patients treated with VELCADE (bortezomib). It has, however, been reversible. Patients with PRES can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. If PRES occurs, treatment with VELCADE should be stopped.

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

Gastrointestinal problems (nausea, diarrhea, constipation, and vomiting) are generally mild to moderate. Most symptoms may be managed with medications, although some may be more serious. If you have these symptoms, ask your healthcare team about medications that you can take to help prevent these side effects.

Some ways to cope with nausea and vomiting:

  • Avoid big meals. Instead, eat small meals and snacks throughout the day.
  • Eat and drink slowly.
  • Wear loose-fitting clothing.
  • Drink cool, clear liquids.
  • Avoid greasy, spicy, or heavily flavored foods.
  • Try eating food with ginger, such as ginger snaps and ginger ale, which might help with nausea.

Some ways to cope with diarrhea:

  • Eat frequent, small meals.
  • Avoid caffeine and alcohol.
  • Avoid fiber, sweets, and greasy, spicy foods.
  • Drink plenty of water so that your body will have enough fluids.
  • Eat foods high in potassium, like bananas, potatoes, and oranges.

Neutropenia and Leukopenia (low levels of neutrophils and leukocytes, which are types of white blood cells) and Thrombocytopenia (low levels of platelets)

VELCADE (bortezomib) can cause low levels of white blood cells (cells that fight infection) and/or platelets (cells that form clots).

  • You will have regular blood tests to check your cell counts during your treatment with VELCADE.
  • During your treatment cycle, there is a period (usually 10 days) when no VELCADE, melphalan, or prednisone is received. During that time, both platelets and neutrophils generally return to their original levels.
  • If the number of these platelets and neutrophils is very low, your doctor may change the dose and/or the 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.

Tumor Lysis Syndrome (TLS)

TLS is a condition that can occur after cancer treatment. As tumor cells die, they break apart and cause changes in certain chemicals in the blood. This could cause damage to your kidneys and heart. Your healthcare team will routinely monitor your blood and urine for signs of TLS. If you develop TLS, your doctor will take steps to treat it.

Asthenia (fatigue, malaise, and weakness)

Asthenia (fatigue, malaise, and weakness) may occur during treatment.

Some ways to cope with asthenia:

  • Get plenty of rest.
  • Eat nutritious food.
  • Drink enough water so that your body will have enough fluids.
  • Maintain some daily activity.

Your doctor or nurse can suggest ways to help you manage fatigue and tell you how much activity is right for you.

Anemia (a low level of red blood cells)

Anemia (a low level of red blood cells) may occur temporarily during treatment with VELCADE (bortezomib). Red blood cells carry oxygen. A low number of red blood cells may lead to symptoms such as fatigue (tiredness) and shortness of breath. Your doctor may decide to treat anemia with medication or a blood transfusion.

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 1 side of the body) may develop during treatment with VELCADE (bortezomib). Patients with multiple myeloma have a higher risk for developing it because their immune system is weakened. Your doctor might suggest taking an antiviral medication to help decrease your risk for this condition.

Pyrexia (fever)

Pyrexia (fever) may occur after VELCADE (bortezomib) is administered. A cause of fever may be infections.

Some ways to avoid infections and fever:

  • Wash your hands often.
  • Avoid crowds.
  • Clean cuts and scrapes immediately with warm water and soap.
  • Take a shower or bathe daily.

If you experience a fever or infection, contact your healthcare team.

Anorexia (decreased appetite)

Anorexia (decreased appetite) is a condition that may result from taking VELCADE (bortezomib) (described above, including nausea, diarrhea, constipation, and vomiting). Drinking more fluids can help prevent dehydration (too much loss of body fluids). Eating frequent small meals may also help.

When to contact the doctor

How well you and your healthcare team talk to each other is one of the most important parts of treatment. But talking to your doctor or nurse isn't always easy. It takes time and effort on your part as well as your healthcare team’s.

It is important to tell your healthcare team if you are experiencing any side effects. Be sure to tell them about all the medications you may be taking, including over-the-counter medicines and herbal products.

Your doctor may prescribe medicines to help lessen or even avoid some side effects. He or she may decide to give you VELCADE (bortezomib) subcutaneously, lower your dose of VELCADE or, in some cases, stop treatment with VELCADE.

You should call the doctor or healthcare team if you have any of the following:

  • Fever or chills
  • Bruising or bleeding
  • Persistent nausea, vomiting, or diarrhea
  • Shortness of breath or cough that gets worse
  • Development of jaundice (yellow color to the eyes and skin)
  • Dizziness, feeling of being light-headed, or fainting spells
  • Reduced eyesight or blurred vision
  • An increase or decrease in blood pressure
  • Swelling of feet, ankles, or legs
  • Changes in blood sugar levels if you have diabetes
  • Rash
  • Tingling or numbness of hands or feet
  • Any other symptoms out of the ordinary or changes in your medical condition

Be ready for your next appointment

Prepare for your next meeting with your healthcare team by using the VELCADE (bortezomib) Doctor Discussion Guide, which includes an organized list of questions you create to use with your healthcare team.

If you are having dizziness, fatigue, or fainting spells, you should not drive or operate machinery. If you are vomiting or having diarrhea, you should remember to drink adequate amounts of liquids to avoid dehydration. When you’re in doubt about any symptoms you might be having, call your doctor or nurse.

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Indications and Important Safety Information for VELCADE® (bortezomib)

What is VELCADE used for?

VELCADE (bortezomib) 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 (bortezomib) 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 problems. 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 problems. 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.
  • Posterior reversible encephalopathy syndrome (PRES). There have been reports of a rare, reversible condition involving the brain, called PRES, in patients treated with VELCADE. Patients with PRES can have seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems. Treatment with VELCADE should be stopped in cases of PRES.
  • Gastrointestinal problems. VELCADE (bortezomib) 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). VELCADE can cause low levels of white blood cells (infection-fighting cells). 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.
  • Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of platelets (clot-forming cells). If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion.
    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.
  • Tumor lysis syndrome (TLS). TLS is a syndrome that causes a chemical imbalance in the blood that could lead to heart and/or kidney problems. 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.

More than 1 in 5 patients (20%) receiving VELCADE have experienced the following side effects: nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia (nerve pain), anemia, leukopenia (low levels of white blood cells), constipation, vomiting, lymphopenia (low levels of a certain type of white blood cells), rash, pyrexia (fever), and anorexia.

What other information should you discuss with your doctor?

Women should avoid becoming pregnant or breast-feeding while being treated with VELCADE (bortezomib). Discuss with your doctor when it is safe to restart breast-feeding 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 any other medications, including prescription and 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. Additional information is available on the Web site VELCADE.com.

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

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