Generic Name: bortezomib (bor-TEZ-oh-mib)
Brand Name: Velcade

Velcade is used for:

Treating certain types of cancer (eg, mantle cell lymphoma, multiple myeloma). It may also be used for other conditions as determined by your doctor.

Velcade is an antineoplastic (cancer chemotherapy) medicine. It works by blocking certain proteins within the cancer cell, causing the cell to die. This helps to slow the growth and spread of the cancer.

Do NOT use Velcade if:

  • you are allergic to any ingredient in Velcade, or to boron or mannitol
  • you are taking carbamazepine, efavirenz, enzalutamide, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Velcade:

Some medical conditions may interact with Velcade. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, a low white blood cell count, low blood platelets, peripheral neuropathy (numbness, pain, or burning sensations in the hands or feet) or other nerve problems, heart problems (eg, congestive heart failure), low blood pressure, diabetes, lung problems, or herpes infection (eg, genital herpes, shingles, cold sores)
  • if you are dehydrated, are on dialysis, or have a history of fainting

Some MEDICINES MAY INTERACT with Velcade. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diabetes medicines (eg, glyburide, metformin) because the risk of high or low blood sugar may be increased
  • Alpha-blockers (eg, terazosin), medicines for high blood pressure, or any other medicines that may lower your blood pressure because the risk of low blood pressure and fainting may be increased. Ask your doctor or pharmacist if you are unsure if any of your medicines may lower your blood pressure
  • Azole antifungals (eg, itraconazole, ketoconazole) or protease inhibitors (eg, ritonavir) because they may increase the risk of Velcade's side effects
  • Carbamazepine, efavirenz, enzalutamide, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Velcade's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Velcade may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Velcade:

Use Velcade as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Drinking extra fluids while you are taking Velcade is recommended. Check with your doctor for instructions.
  • Velcade is given as an injection into a vein or under the skin at your doctor's office, hospital, or clinic. Velcade is not intended to be injected into the spinal cord. Contact your health care provider if you have any questions.
  • It is very important that each dose is given at the scheduled time. If you miss a dose of Velcade, contact your doctor right away to establish a new dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Velcade.

Important safety information:

  • Velcade may cause dizziness, fatigue, fainting, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Velcade with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Velcade may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Velcade may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower your chance of getting cut, bruised, or injured.
  • Velcade may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Contact your doctor if you experience new or worsening nerve problems (eg, tingling, numbness, pain, or burning in the feet or hands; weakness in the arms or legs). Your dose may need to be changed.
  • A serious and possibly fatal condition called tumor lysis syndrome (TLS) has been reported in certain patients taking Velcade. Contact your doctor right away if you develop symptoms, such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
  • Heart failure, as well as heart failure that has gotten worse in people who already have it, has happened with Velcade. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, irregular heartbeat, or swelling in the arms or legs that is new or worse.
  • Serious and sometimes fatal lung problems have happened with Velcade. Call your doctor right away if you have lung or breathing problems (eg, trouble breathing, shortness of breath, a cough that is new or worse).
  • A serious and sometimes fatal brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Velcade. Call your doctor right away if you have confusion, seizures, severe headache, sluggishness, or vision changes (eg, vision loss).
  • Carry an ID card at all times that says you take Velcade.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you experience dizziness, light-headedness, or fainting.
  • Diabetes patients - Velcade may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Women who may become pregnant should avoid becoming pregnant while being treated with Velcade. Be sure to use effective birth control while using Velcade. If you have questions about effective birth control, talk with your doctor.
  • Lab tests may be performed while you use Velcade. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Velcade may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Velcade while you are pregnant. It is not known if Velcade is found in breast milk. Do not breast-feed while using Velcade.

Possible side effects of Velcade:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; nausea; stomach upset; taste changes; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; changes in thinking or strength; chest pain; decreased balance or coordination; dry mouth or eyes; fainting; fast, slow, or irregular heartbeat; memory problems; mental, mood, or behavior changes (eg, agitation, depression, suicidal thoughts); new or worsening nerve problems (eg, burning, numbness, pain, or tingling in the hands or feet; weakness in the arms or legs); one-sided weakness; redness, burning, pain, swelling, or leaking at the injection site; severe or persistent diarrhea, vomiting, constipation, or stomach pain; severe or persistent headache or dizziness; severe or persistent muscle pain, cramping, or weakness; severe or persistent tiredness or weakness; signs of an infection (chills, cough, fever, persistent sore throat); slurred speech; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; bloody or black, tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; bleeding that is very bad or that you cannot stop); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent nausea or loss of appetite); trouble walking or talking.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Velcade:

Velcade is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Velcade, please talk with your doctor, pharmacist, or other health care provider.
  • Velcade is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Velcade or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Velcade. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Velcade. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Velcade.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web1)