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 adults with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of adults 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, or SC). 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:
- Nerve problems (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 (hypotension). 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 (cardiac toxicity). 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 (pulmonary toxicity). 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.
Brain swelling (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. It is not known whether restarting VELCADE therapy in patients previously experiencing this complication is safe.
- Stomach and Intestinal problems (gastrointestinal toxicity). VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.
- Low platelet counts (thrombocytopenia). 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.
- Lowered white blood cells (neutropenia). VELCADE can cause low levels of neutrophils which are a type of white blood cells that help to fight infections. 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.
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.
Liver problems (hepatic toxicity). 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. It is not known whether restarting VELCADE therapy in patients previously experiencing this complication is safe.
- Hematologic disease (Thrombotic Microangiopathy, TMA). VELCADE can lead to the formation of blood clots in small blood vessels. These clots can result in low platelets, kidney damage, confusion, and an increased risk of bleeding. Tell your doctor if you develop pinpoint-sized purple dots (petechiae), larger bruises, or you see blood in your urine. Your doctor may stop treatment with VELCADE. It is not known whether restarting VELCADE therapy in patients previously experiencing this complication is safe.
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 tell your doctor?
Women should avoid becoming pregnant while being treated with VELCADE as it could harm your unborn baby. Females should use effective birth control during treatment and for at least seven months after the final dose of VELCADE. If using hormonal contraceptives (for example, the pill), an additional barrier method of contraception (for example, diaphragm or condom) must be used. Males should use effective contraception during treatment with VELCADE and for four months following treatment. Tell your doctor immediately if you think you are pregnant. Do not breastfeed during treatment with VELCADE and for seven months after your final dose of VELCADE.
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 see accompanying VELCADE® (bortezomib) full Prescribing Information.