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|Bortezomib

BORTEZOMIB (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Velcade

† Not commercially available in Canada.

Category

• Antineoplastic

Description

Bortezomib ((bor-TEZ-oh-mib)) belongs to the general group of medicines known as antineoplastics. It is used to treat multiple myeloma in patients who have received at least one treatment that has not helped.

Bortezomib interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by bortezomib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Bortezomib is to be administered only by or under the supervision of your doctor. It is available in the following dosage form:

• Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bortezomib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bortezomib, boron or mannitol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—There is a chance that this medicine may cause birth defects if it is taken by the mother during pregnancy. Studies in rats and rabbits have shown that bortezomib causes birth defects in the fetus and other problems including miscarriage. However, this medicine may be needed in serious diseases or other situations that threaten the mother"s life.

Be sure that you have discussed these possible effects with your doctor before receiving this medicine. Before receiving bortezomib make sure your doctor knows if you are pregnant or if you may become pregnant. It is best to use birth control to prevent pregnancy while you are receiving bortezomib. Tell your doctor right away if you think you have become pregnant while receiving bortezomib.

Breast-feeding—Because bortezomib may cause serious side effects in the breast-fed baby, breast-feeding is generally not recommended while you are receiving this medicine.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of bortezomib in children with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bortezomib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Amiodarone, (e.g., Cordarone) or
• Antivirals, (e.g., Stavudine) or
• Isoniazid, (e.g.; Nydrazid) or
• Nitrofurantoin, (e.g., Macrodantin, Macrobid) or
• Statins (e.g., Lipitor, Zocor, Mevacor)—Use of these medicines with bortezomib may increase the chance of peripheral neuropathy (tingling, burning, numbness, or pain in your hands and feet)

• Antihypertensives (high blood pressure medicine)—May increase the chances of low blood pressure (hypotension)

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC] medicine).

Other medical problems—The presence of other medical problems may affect the use of bortezomib. Make sure you tell your doctor if you have any other medical problems, especially:

• Dehydration or
• Syncope, history of—May cause orthostatic/postural hypotension

• Heart disease—Bortezomib may make your heart problems worse or cause new heart problems. Your doctor will watch for this side effect.

• Kidney disease or
• Liver disease—Higher blood levels of bortezomib may result and a smaller dose may be needed

• Peripheral neuropathy—bortezomib may make the symptoms worse or cause new symptoms

• Tumor lysis syndrome, risk of—Bortezomib may increase your chance of getting this side effect. Your doctor will watch for this side effect.

Proper Use of This Medicine

Dosing—The dose of bortezomib will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of bortezomib. If you have any questions about the proper dose of bortezomib, ask your doctor.

• For injection dosage form
  • For treatment of multiple myeloma
    • Adults—
      • Patients without symptoms or with Grade 1 symptoms of peripheral neuropathy (paresthesias and/or loss of reflexes without pain or loss of function)—1.3 milligrams (mg) per m² twice weekly for two weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21). For longer treatment of more than 8 cycles, bortezomib may be taken on the regular schedule or on a maintenance schedule of once a week for 4 weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23-35). At least 72 hours should elapse between consecutive dose.
      • Patients with Grade 1 with pain or Grade 2 symptoms of peripheral neuropathy (interfering with function but not with activities of daily living)—1 milligram (mg) per m² twice weekly for two weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21). At least 72 hours should elapse between consecutive dose.
      • Patients with Grade 2 with pain or Grade 3 symptoms of peripheral neuropathy (interfering with activities of daily living)—Your doctor will withhold therapy until toxicity resolves. When toxicity resolves your doctor will reduce your dose to 0.7 mg/m² once per week.
      • Patients with Grade 4 symptoms of peripheral neuropathy (permanent sensory loss that interferes with function)—Your doctor will discontinue therapy
      • Your doctor may decrease your dose for severe side effects excluding peripheral neuropathy.
    • Children—Bortezomib is not usually recommended in children.

Missed dose—Discuss with your doctor what to do

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

This medicine may cause vomiting and diarrhea, so it is important to drink plenty of fluids. If you experience dizziness or lightheadedness, contact your doctor. These could be symptoms of dehydration (not enough water in your body).

If you are diabetic and you take an oral antidiabetic medicine, you should check your blood sugar level often and report any unusual changes to your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. Discuss these possible effects with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, bortezomib is used in certain patients with the following medical conditions:

• Mantle cell lymphoma

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Developed: 12/18/2003
Revised: 08/01/2005

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