Velcade (bortezomib) belongs to a class of medications called antineoplastic agents. Bortezomib works by killing cancer cells.

Velcade is used to treat people with multiple myeloma (a type of cancer of the bone marrow).

Velcade is also used to treat people with mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system).

Velcade is sometimes given after other cancer medications have been tried without successful treatment.

Velcade may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Velcade can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not be treated with Velcade if you are allergic to bortezomib, or to mannitol, or boron.

To make sure Velcade is safe for you, tell your doctor if you have ever had:

• numbness, tingling, or burning pain in your hands or feet;

• high or low blood pressure;

• heart disease, congestive heart failure;

• headache, confusion, thinking problems, weakness, vision loss, seizure;

• a low level of platelets or low white or red blood cell counts;

• skin rash or herpes zoster (also called shingles);

• lung disease, or breathing problems;

• diabetes;

• if you are dehydrated;

• liver disease; or

• kidney disease (or if you are on dialysis).

Bortezomib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Velcade is injected into a vein or under your skin. A healthcare provider will give you this injection.

You may be given medication to prevent nausea or vomiting while you are receiving Velcade.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Usual Adult Dose for Lymphoma:

DOSAGE IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA:
1.3 mg/m2 as a bolus IV injection twice weekly in combination with IV rituximab, cyclophosphamide, doxorubicin, and oral prednisone for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

Comments:
-The three week period is considered a treatment cycle.
-A minimum of 72 hours should elapse between consecutive doses of Velcade.
-For patients with a response first documented at cycle 6, two additional cycles (for a total of 8 cycles) are recommended.

FOR USE IN THE TREATMENT OF RELAPSED MANTLE CELL LYMPHOMA:
-Usual dose: 1.3 mg/m2 as a bolus IV injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21). Therapy extending beyond 8 cycles may be administered by the standard schedule or may be given once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest (days 23 through 35).

Uses: For the treatment of mantle cell lymphoma

Usual Adult Dose for Multiple Myeloma:

FOR USE IN THE TREATMENT OF PREVIOUSLY UNTREATED MULTIPLE MYELOMA:
-Usual dose: 1.3 mg/m2 administered as a 3 to 5 second bolus IV injection or subcutaneously in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles:
-In cycles 1 through 4, Velcade is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In cycles 5 through 9, Velcade is administered once weekly (days 1, 8, 22, and 29).

Comments:
-At least 72 hours should elapse between consecutive doses of Velcade.

FOR USE IN THE TREATMENT OF RELAPSED MULTIPLE MYELOMA:
-Usual dose: 1.3 mg/m2 as a bolus intravenous injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21). Therapy extending beyond 8 cycles may be administered by the standard schedule or may be given once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest (days 23 through 35).

Comments:
-Velcade may be administered alone or in combination with dexamethasone.
-The three week period is considered a treatment cycle.
-A minimum of 72 hours should elapse between consecutive doses of Velcade.
-Patients with multiple myeloma who have previously responded to treatment with Velcade (either alone or in combination) and who have relapsed at least 6 months after their prior therapy may be started on the last tolerated dose.

Use: For the treatment of multiple myeloma (who had previously responded to treatment with this drug and who have relapsed at least 6 months after completing treatment)

You should not be treated with Velcade if you are allergic to bortezomib, or to mannitol, or boron.

To make sure Velcade is safe for you, tell your doctor if you have ever had:

• numbness, tingling, or burning pain in your hands or feet;

• high or low blood pressure;

• heart disease, congestive heart failure;

• headache, confusion, thinking problems, weakness, vision loss, seizure;

• a low level of platelets or low white or red blood cell counts;

• skin rash or herpes zoster (also called shingles);

• lung disease, or breathing problems;

• diabetes;

• if you are dehydrated;

• liver disease; or

• kidney disease (or if you are on dialysis).

Bortezomib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Call your doctor for instructions if you miss an appointment for your Velcade injection.

In a medical setting an overdose would be treated quickly.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Velcade: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Velcade may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Velcade can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Velcade may cause serious side effects. Call your doctor at once if you have:

• headache, confusion, thinking problems, weakness, vision loss, seizure, a light-headed feeling, like you might pass out;

• pain, bruising, swelling, or irritation where the medicine was injected;

• severe or ongoing nausea, vomiting, diarrhea, or constipation, stomach pain;

• fever with shortness of breath or trouble breathing;

• dehydration - dizziness, confusion, feeling very thirsty, less urination;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• heart problems - swelling, rapid weight gain, feeling short of breath; or

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Velcade side effects may include:

• numbness, burning pain, or tingly feeling;

• loss of appetite, nausea, vomiting;

• diarrhea, constipation;

• fever, chills, cold or flu symptoms;

• low blood cell counts;

• skin rash; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can interact with bortezomib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.