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Please see the VELCADE® (bortezomib) indication and Important Safety Information

Indication and Important Safety Information for VELCADE® (bortezomib) for Injection

What is VELCADE?
VELCADE is a prescription medicine used to treat adults with multiple myeloma (a cancer of the plasma cells).

It is not known if VELCADE is safe and effective in children.

Who should not receive VELCADE?
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. Tell your healthcare provider if you get any new or worsening symptoms, including: muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. 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. 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.
  • 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 (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.
  • Low platelet counts (thrombocytopenia). VELCADE can cause low levels of platelets (clot-forming cells). Your doctor may recommend a platelet transfusion or other supportive care. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
  • Lowered white blood cells (neutropenia). VELCADE can cause low levels of neutrophils which are a type of white blood cell 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 caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment and/or an abnormal heartbeat. Your healthcare provider may do blood tests to check for TLS.
  • 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 pain in your right upper stomach-area. 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, and may lead to death. Tell your doctor if you develop pinpoint-sized purple dots (petechiae), larger bruises, or if 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.

The most commonly reported side effects in clinical studies include:

  • Nausea
  • Diarrhea
  • Low platelets (thrombocytopenia)
  • Decreased number of neutrophils, a type of white blood cell (neutropenia)
  • Nerve damage (peripheral neuropathy)
  • Fatigue
  • Nerve pain (neuralgia)
  • Low red blood cells (anemia)
  • Low white blood cells (leukopenia)
  • Constipation
  • Vomiting
  • Decreased number of lymphocytes, a type of white blood cell (lymphopenia)
  • Rash
  • Fever (pyrexia)
  • Lack of appetite (anorexia)

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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you take VELCADE, tell your healthcare provider about all of your medical conditions, including if you:

  • Have liver disease or 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.
  • Develop a rash of any type or have skin pain while receiving VELCADE.
  • Are pregnant or plan to become pregnant. VELCADE can harm your unborn baby.
    • Your healthcare provider will determine whether or not you are pregnant before you start treatment with VELCADE.
    • Avoid becoming pregnant during treatment with VELCADE.
    • Females who are able to become pregnant must use effective birth control during treatment and for seven months after your last 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 with female sexual partners of reproductive potential must use contraception during treatment with VELCADE and for four months following the last dose of VELCADE.
    • Tell your healthcare provider right away if you or your partner become pregnant while you are receiving VELCADE or within seven months following the last dose.
    • VELCADE may have an effect on either male or female fertility.
  • Are breastfeeding or plan to breastfeed. It is not known if VELCADE passes into breast milk, or if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with VELCADE and for two months after your final dose of VELCADE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VELCADE and other medicines may affect each other. Talk to your healthcare provider before starting any new medicines during treatment with VELCADE.

What should I avoid while taking VELCADE?
VELCADE may cause fatigue, dizziness, fainting (syncope), or lightheadedness when you sit or stand up. You should not drive or operate machinery if you experience any of these symptoms.

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).

Please see the NINLARO® (ixazomib) indication and Important Safety Information

Indication and Important Safety Information for NINLARO

Uses of NINLARO

NINLARO® (ixazomib) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

It is not known if NINLARO is safe and effective in children.

NINLARO may cause serious side effects, including:

  • Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
  • Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms.
  • Nerve problems are common with NINLARO and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms including: tingling, numbness, pain, a burning feeling in your feet or hands, or weakness in your arms or legs.
  • Swelling is common with NINLARO and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
  • Skin Reactions. Tell your healthcare provider if you get a new or worsening rash.
  • Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination.
  • Liver problems. Tell your healthcare provider if you get these signs of a liver problem: yellowing of your skin or the whites of your eyes; pain in your right upper-stomach area.

Other common side effects have occurred. Tell your healthcare provider if you get new or worsening back pain, skin rash and pain (shingles) as a result of reactivation of the chicken pox virus (herpes zoster), lowered white blood cells (neutropenia) that may increase the risk of infection, or vision conditions including blurred vision, dry eye, and pink eye (conjunctivitis).

These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking NINLARO, tell your healthcare provider about all your medical conditions, including if:

  • You have liver problems or kidney problems or are on dialysis.
  • You or your partner are pregnant or plan to become pregnant. NINLARO can harm your unborn baby. Avoid becoming pregnant during treatment with NINLARO. Both male and female patients on NINLARO should use effective birth control during treatment and for 90 days after the final dose of NINLARO. If using hormonal contraceptives (for example, the pill), an additional barrier method of contraception (for example, diaphragm or condom) must be used.
  • You are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with NINLARO and for 90 days after your final dose of NINLARO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements or before starting any new medicines.