Velcade contains bortezomib, which is a proteasome inhibitor and an antineoplastic agent in the form of a modified dipeptidyl boronic acid. It is formulated as a sterile lyophilized powder for injection, available in 3.5 mg single-dose vials. It can be administered intravenously or subcutaneously and includes mannitol as a key inactive ingredient.

How should I use this medication?

This medication is injected into a vein or under the skin. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
• Pain, tingling, or numbness in the hands or feet
• Severe or prolonged diarrhea
• Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Fatigue
• Loss of appetite
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dehydration
• Diabetes
• Heart disease
• Liver disease
• Tingling of the fingers or toes or other nerve disorder
• An unusual or allergic reaction to bortezomib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Ketoconazole
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 7 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 7 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 2 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.