VELCADE® (bortezomib) treatment schedules

VELCADE (bortezomib) is given in cycles.

  • A cycle includes the number of weeks you receive a drug, and the time spent resting and not receiving the drug
  • The length of treatment and number of cycles depends on your treatment goals and how well you feel

You and your doctor will discuss your treatment plan. You’ll also decide which way of receiving VELCADE (bortezomib)—subcutaneously or intravenously—is best for you. The schedule and dose are the same for both.

"Last year, I began subcutaneous injections of VELCADE on the dosing schedule recommended by my doctor. My numbers continue to improve and, I’m happy to say, with extended therapy with VELCADE, I’m in partial remission." -Sheryl

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Initial treatment for multiple myeloma

VELCADE® (bortezomib) treatment schedule over the course of 1 year

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

First 6 months—Twice-weekly doses

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  • VELCADE 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

Next 6 months —Once-weekly maintenance schedule

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  • VELCADE is given once a week for 2 weeks, followed by a 13-day rest period
  • This sequence is repeated to make one 6-week cycle
  • There are 5 cycles in this treatment phase

You must wait at least 3 days between VELCADE 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 50 weeks out of a planned 54 weeks.
"Jim's doctors continue to monitor his response, and we continue to be pleased. There was a period where Jim was hoping to take a break for a while, but his doctor explained that it was important to stay on VELCADE for up to a year so he'd get the most benefit out of it."-Marion, caregiver

Retreatment with VELCADE (bortezomib) for relapsed multiple myeloma

For people whose multiple myeloma came back (relapsed) at least 6 months after achieving a benefit with VELCADE (bortezomib), retreatment in a clinical trial lasted about 6 months

Retreatment schedule

Twice-weekly doses for about 6 months

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  • VELCADE (bortezomib) is administered as a single agent or in combination with dexamethasone in 3-week cycles
  • Each cycle consists of twice-a-week doses of VELCADE for 2 weeks, followed by a 10-day rest period
  • This schedule can be repeated up to 8 times (about 6 months)
  • Your previous treatment schedule with VELCADE may have been different based on where you were in your treatment journey
  • Your doctor may start your retreatment with VELCADE at the last dose you were receiving

You must wait at least 3 days between VELCADE doses.

3 out of 8 people responded to retreatment with VELCADE (bortezomib), with responses lasting about 6.5 months.*

*Half the patients' responses lasted less than 6.5 months and half the patients' responses lasted more than 6.5 months.

Relapsed multiple myeloma and new to VELCADE (bortezomib)

For people with multiple myeloma that came back (relapsed) who were new to VELCADE (bortezomib), treatment in a clinical trial lasted about 6 months

Treatment schedule

Twice-weekly doses for about 6 months

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  • VELCADE (bortezomib) is taken in 3-week cycles
  • Each cycle consists of twice-a-week doses of VELCADE for 2 weeks, followed by a 10-day rest period
  • Treatment lasts 8 cycles or about 6 months

Continuing treatment—Once-weekly maintenance schedule or twice-weekly standard schedule

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  • Your doctor may decide to extend therapy beyond 8 cycles. You may be kept on a standard schedule or switched to a weekly maintenance schedule for as long as you and your doctor determine it is appropriate
  • This requires taking VELCADE once a week for 4 weeks, followed by a 13-day rest period

You must wait at least 3 days between VELCADE (bortezomib) doses.

Relapsed mantle cell lymphoma

For people whose mantle cell lymphoma came back (relapsed), treatment in a study lasted about 1 year for some patients. Those who responded to treatment were on VELCADE (bortezomib) for a median of about 6 months.

Treatment schedule

Twice-weekly doses for about 6 months

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  • VELCADE is taken in 3-week cycles
  • Each cycle consists of twice-a-week doses of VELCADE for 2 weeks, followed by a 10-day rest period
  • Treatment lasts 8 cycles or about 6 months

Continuing treatment—Once-weekly maintenance schedule or twice-weekly standard schedule

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  • Your doctor may decide to extend therapy beyond 8 cycles. You may stay on a standard schedule or be switched to a weekly maintenance schedule for as long as you and your doctor determine it is appropriate
  • This requires taking VELCADE once a week for 4 weeks, followed by a 13-day rest period

You must wait at least 3 days between VELCADE doses.

Paying for Treatment

Find out how the makers of VELCADE (bortezomib) may be able to help.

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VELCADE INFO LINE: 1-866-835-2233

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.

© 2014 Millennium Pharmaceuticals, Inc. A wholly-owned subsidiary of Takeda Pharmaceutical Company Limited       V-14-0068 03/14