bortezomib

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

What is bortezomib?

Bortezomib interferes with the growth of some cancer cells and keeps them from spreading in your body.

Bortezomib is used to treat multiple myeloma and mantle cell lymphoma.

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

Bortezomib may also be used for purposes not listed in this medication guide.

What is the most important information I should know about bortezomib?

Bortezomib 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.

Slideshow: Flashback: FDA Drug Approvals 2013

Bortezomib 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).

What should I discuss with my healthcare provider before receiving bortezomib?

You should not use this medication if you are allergic to bortezomib, mannitol, or boron.

To make sure bortezomib is safe for you, tell your doctor if you have:

  • diabetes;

  • liver disease;

  • kidney disease, or if you are on dialysis;

  • a bleeding or blood clotting disorder;

  • a low level of platelets or white or red blood cells;

  • heart disease, congestive heart failure;

  • herpes or a history of shingles;

  • high or low blood pressure; or

  • nerve problems such as numbness, burning, pain, or tingly feeling.

FDA pregnancy category D. Do not use bortezomib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether bortezomib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using bortezomib. Ask your doctor how long to wait before breast-feeding again.

How is bortezomib given?

Bortezomib is injected into a vein through an IV.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare provider will give you this injection.

Bortezomib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving bortezomib?

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

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid becoming dehydrated if you have any vomiting or diarrhea. Symptoms of dehydration include dizziness, dry mouth, fainting, or hot and dry skin. Talk with your doctor about how best to keep yourself hydrated.

Bortezomib side effects

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

Bortezomib 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.

Also call your doctor at once if you have:

  • new or worsening nerve problems such as numbness, burning, pain, weakness, or tingly feeling;

  • a light-headed feeling, like you might pass out;

  • chest pain, dry cough, swelling in your hands or ankles, feeling short of breath, even with mild exertion;

  • severe headache, confusion, and/or seizure (convulsions);

  • severe constipation, bloody or tarry stools, vomit that looks like blood or coffee grounds;

  • fever, chills, body aches, flu symptoms, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

  • red bumps, spreading skin rash, painful skin lesions on your arms, face, or neck;

  • fast or slow heart rate, weak pulse, lower back pain, blood in your urine, little or no urinating;

  • muscle weakness, tightness, or contraction, overactive reflexes; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • upset stomach, vomiting;

  • diarrhea, constipation, bloating;

  • headache, mild dizziness;

  • mild rash or itching; 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.

See also: Side effects (in more detail)

Bortezomib dosing information

Usual Adult Dose for Lymphoma:

For use in the treatment of mantle cell lymphoma:

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)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

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, bortezomib is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In cycles 5 through 9, bortezomib is administered once weekly (days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of bortezomib.

For use in the treatment of relapsed multiple myeloma:

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)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

What other drugs will affect bortezomib?

Many drugs can interact with bortezomib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with bortezomib, especially:

  • dexamethasone;

  • rifabutin, rifampin, rifapentine;

  • St. John's wort;

  • an antibiotic--clarithromycin, erythromycin, telithromycin;

  • an antifungal medication--clotrimazole, itraconazole, ketoconazole, voriconazole;

  • an antidepressant--nefazodone, paroxetine, sertraline;

  • a barbiturate--amobarbital, butabarbital, mephobarbital, secobarbital, phenobarbital;

  • diabetes medicine you take by mouth (your dose may need to be adjusted when your bortezomib treatment starts);

  • HIV/AIDS medicine--atazanavir, delavirdine, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, saquinavir, ritonavir;

  • medicines to treat narcolepsy--armodafinil, modafinil; or

  • seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone.

This list is not complete and many other drugs can interact with bortezomib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about bortezomib.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.03. Revision Date: 2013-07-01, 12:26:12 PM.

Hide
(web2)