VELCADE® (bortezomib) frequently asked questions

If I have multiple myeloma, can I receive VELCADE (bortezomib) after a stem cell transplant?

Yes. The FDA has approved VELCADE (bortezomib) for the treatment of people with relapsed multiple myeloma who are new to VELCADE. The clinical trial included people who had received a stem cell transplant. Talk with your doctor or healthcare team about whether VELCADE may be right for you.

VELCADE is also approved as an initial treatment for people with previously untreated multiple myeloma.

If I have or am at high risk of getting peripheral neuropathy, can subcutaneous VELCADE (bortezomib) be an alternative to intravenous VELCADE?

Yes, patients with preexisting peripheral neuropathy (PN) or those who are at a high risk for it may be started on VELCADE (bortezomib) therapy subcutaneously. PN is caused by nerve damage that results in tingling, numbness, burning, or weakness in the hands or feet.

A study showed differences in occurrence of PN between people treated with intravenous VELCADE and those treated with subcutaneous VELCADE. This trial included 222 relapsed people who had been previously treated for multiple myeloma.

In this study:

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

More about possible side effects

What if I need help with transportation to and from my appointments?

If you need help getting to or from your appointments, we may be able to connect you with the help that you need. There are numerous national organizations that provide transportation to and from medical appointments for people with multiple myeloma and mantle cell lymphoma who are in need of financial assistance.

For more information, click here.

How often should I receive VELCADE (bortezomib)?

How long should I take VELCADE (bortezomib) if I have previously untreated multiple myeloma?

VELCADE (bortezomib) treatment is scheduled for the duration of 1 year

VELCADE (bortezomib) is given twice weekly followed by once-weekly dosing

First 6 months—Twice-weekly doses

  • VELCADE (bortezomib) is given twice a week for 2 weeks, followed by a 10-day rest period
  • This sequence is then repeated to make one 6-week cycle
  • There are 4 cycles in the first treatment phase
ZOOM
  • VELCADE is given once a week for 2 weeks, followed by a 13-day rest period
  • This sequence is then repeated to make one 6-week cycle
  • There are 5 cycles in the second treatment phase

You must wait at least 3 days between VELCADE (bortezomib) doses. Two drugs, called melphalan and prednisone (MP), are also taken on the first 4 days of every cycle throughout the year.

In a study, half of the people on VELCADE-based therapy continued to receive VELCADE for at least 50 weeks out of a planned 54 weeks. Learn more

How long should I take VELCADE (bortezomib) if I have mantle cell lymphoma and have never been treated before?

Previously untreated mantle cell lymphoma

VELCADE (bortezomib) is given twice a week for 2 weeks followed by a 10-day rest period. This can be repeated up to 6 times.

In a clinical trial, VELCADE was given according to this schedule:

ZOOM
  • For people who achieve a response at week 18 (cycle 6), an additional 6 weeks (2 cycles) of treatment is recommended
  • It's important to take treatment as prescribed by your healthcare team and discuss any side effects with them. There are many things to consider when choosing a treatment plan that's right for you
  • 8% of people stopped treatment due to side effects

You must wait at least 3 days between VELCADE doses.

Is there any financial assistance that can help me pay for VELCADE (bortezomib)?

VELCADE (bortezomib) has a comprehensive Reimbursement Assistance Program, VRAP. Dedicated VELCADE case managers can help patients and caregivers learn more about:

  • Understanding insurance and coverage*
  • Alternative and supplemental insurance coverage options
  • Information on co-payment foundation support
  • Referrals for transportation resources

If you don’t have insurance coverage for VELCADE, you may be eligible for the VELCADE Patient Assistance Program. If you qualify, your VELCADE will be delivered without charge to your physician. For more information or to enroll, contact a VELCADE case manager.

You may also be eligible for co-pay assistance through third-party companies. Click here to learn more about foundations that may be able to help.

*VRAP does not file or appeal claims for callers and cannot guarantee that you will be successful in obtaining reimbursement.

Learn more Learn more Learn more Learn more

 

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.
USO/BOR/16/0005   7/16