Bortezomib (bor-TEZ-oh-mib)

Treats multiple myeloma and mantle cell lymphoma.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or into a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bortezomib works. Tell your doctor if you are using the following:
  • Ketoconazole, rifampin, ritonavir, St John's wort
  • Blood pressure medicine
  • Insulin or oral diabetes medicine

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for 2 months after the last dose.
• Tell your doctor if you have liver disease, heart disease, heart failure, breathing or lung problems, diabetes, low blood pressure, or a history of fainting or herpes virus infection.
• This medicine may cause the following problems:
  • New or worsening peripheral neuropathy (nerve problem)
  • Low blood pressure
  • Heart problems
  • Lung or breathing problems
  • Posterior reversible encephalopathy syndrome (brain disorder)
  • Stomach or bowel problems (including blockage)
  • Tumor lysis syndrome (metabolic problem that can be life-threatening)
  • Liver problems
  • Thrombotic microangiopathy (blood vessel damage), including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you are dizzy.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen. Make sure you drink plenty of liquids so you do not become dehydrated.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, painful or difficult urination, bloody urine
• Chest pain, cough, trouble breathing, fast, slow, or uneven heartbeat
• Dark urine or pale stools, stomach pain, yellow skin or eyes
• Fever, chills, sore throat, body aches, muscle or joint pain
• Lightheadedness, dizziness, or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe stomach pain, diarrhea, nausea, vomiting, constipation
• Sudden or severe headache, seizures, confusion, problems with vision, speech, or walking
• Swelling in your face, arms, legs, ankles, or feet, rapid weight gain
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Loss of appetite, weight loss
• Mild diarrhea, constipation, nausea, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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