Your healthcare team may be able to help you manage side effects, which may help you stay on VELCADE® (bortezomib)

  • When starting treatment, be sure to talk with your doctor about any other health conditions you have or medications you're taking. While you're receiving VELCADE (bortezomib), it's important to speak up about how you feel
  • If you have any side effects with VELCADE, it's important to tell your doctor or nurse right away
  • Your healthcare team might decide to change your dose or schedule of VELCADE to help manage side effects. This may help you stay on VELCADE
"My oncologist…recommended we add VELCADE to my treatment plan. We discussed the benefits and risks, and we felt it was the right choice for me. As a patient and nurse, I can tell you that everyone responds to treatment differently. So, I advise you to always speak to your doctor about what treatment options are best for you." -Terry

When to contact your healthcare team

How well you and your healthcare team talk with each other is one of the most important parts of treatment. But talking with 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 (an injection), 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

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.

Side effects of VELCADE include:OPEN ALL TABS CLOSE ALL TABS PRINT

Fatigue

Fatigue is the feeling of physical, emotional, or mental exhaustion. It is commonly associated with symptoms of multiple myeloma and treatment side effects.

If you experience fatigue, talk with your doctor or healthcare team

  • Your doctor may be able to identify and treat the underlying cause of fatigue, such as anemia or malnourishment
  • Your doctor can prescribe medications to make you feel less tired or more awake
  • Behavioral modification and exercise can help improve mood and sleeping difficulties, resulting in more energy

Peripheral neuropathy

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

  • Report these symptoms immediately to your doctor or nurse, who may be able to help you manage them
  • Your doctor may give you medications to relieve symptoms or lower your dose of VELCADE (bortezomib)
  • Your doctor may also interrupt your treatment until your symptoms get better, or may stop treatment with VELCADE

If you already have peripheral neuropathy or are at high risk, ask your doctor about subcutaneous VELCADE (VELCADE given as a shot).

Subcutaneous VELCADE is associated with fewer and less severe peripheral neuropathy symptoms than
intravenous VELCADE.

  • In a study of 222 patients, peripheral neuropathy rates were 37% with subcutaneous VELCADE versus 50% with intravenous VELCADE for all levels of severity
  • For more severe cases, peripheral neuropathy rates were 6% with subcutaneous VELCADE and 15% with
    intravenous VELCADE

Ask your doctor for everyday strategies for relieving peripheral neuropathy symptoms.

Low blood pressure (hypotension)

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 intravenously. 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.

Nausea, diarrhea, constipation, and vomiting (gastrointestinal problems)

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 drinking ginger ale, which may 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

Low levels of neutrophils and leukocytes, which are types of white blood cells (neutropenia and leukopenia) and low levels of platelets (thrombocytopenia)

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.

A low level of red blood cells (anemia)

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

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

Herpes zoster or shingles (a painful, itchy rash usually located in an area on one 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.

Fever (pyrexia)

Fever (pyrexia) 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 bath daily

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

Decreased appetite (anorexia)

Decreased appetite (anorexia) is a condition that may result from taking VELCADE (bortezomib). Drinking more fluids can help prevent dehydration (too much loss of body fluids). Eating frequent small meals may also help.

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Please see below for Important Safety Information.

Indications and Important Safety Information for VELCADE® (bortezomib)

What is VELCADE used for?

VELCADE (bortezomib) is approved for the treatment of people with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of people with mantle cell lymphoma (a cancer of the lymph nodes).

How is VELCADE administered?

VELCADE is prescribed by a doctor 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 people 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 people 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 people treated with VELCADE. People 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 or other supportive care.
    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 people (20%) receiving VELCADE have experienced the following side effects in one or more clinical trials: neutropenia, thrombocytopenia, peripheral neuropathy, fatigue, nausea, diarrhea, leukopenia (low levels of white blood cells), anemia, constipation, neuralgia (nerve pain), 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). Tell your doctor immediately if you think you are pregnant. 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 nonprescription medications, herbal or dietary supplements, or holistic treatments. St. John’s wort should be avoided.
  • Develop a rash of any type or have skin pain 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 website at VELCADE.com.

Please read the full Prescribing Information for VELCADE.


© 2016 Millennium Pharmaceuticals, Inc.
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