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Generic Name: bortezomib (Intravenous route, Subcutaneous route)

bor-TEZ-oh-mib

Commonly used brand name(s)

In the U.S.

  • Velcade

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Proteasome Inhibitor

Uses For Velcade

Bortezomib injection is given together with melphalan and prednisone to treat multiple myeloma (blood plasma cell cancer) in patients with or without a prior history of treatment, and mantle cell lymphoma in patients who have received at least one treatment and did not worked well.

Slideshow: Flashback: FDA Drug Approvals 2013

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, such as a skin rash, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

This medicine is to be administered only by or under the supervision of your doctor.

Before Using Velcade

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bortezomib injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bortezomib injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Fosphenytoin
  • Phenobarbital
  • Phenytoin
  • Rifabutin
  • Rifapentine
  • St John's Wort

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Itraconazole
  • Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Allergy to boron or
  • Allergy to mannitol—Should not be used in patients with these conditions.
  • Congestive heart failure or
  • Dehydration or
  • Heart disease or
  • Lung disease (e.g., acute respiratory distress syndrome, lung infiltration, pneumonitis, pulmonary hypertension) or
  • Peripheral neuropathy (nerve problem) or
  • Syncope (fainting), history of—Use with caution. May make these conditions worse.
  • Herpes zoster (shingles)—May reactivate this condition.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Velcade

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.

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. This medicine is given through a needle placed in one of your veins or as a shot under your skin (usually in the abdomen or thighs).

You may also receive medicines to help prevent nausea, vomiting, or diarrhea. Ask your doctor or other health caregiver if you should drink extra water while you are using this medicine. This could help you avoid feeling dizzy or lightheaded.

Precautions While Using Velcade

It is very important that your doctor check you at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using this medicine to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may cause some people to become dizzy, drowsy, tired, 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 not alert. You may rise up slowly from sitting or lying position to help prevent lightheadedness or dizziness.

Some people who have used this medicine developed serious heart problems. Tell your doctor right away if you have chest pain or discomfort, shortness of breath, irregular heartbeat, or swelling of the feet, ankles, or legs while you are using this medicine.

This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using this medicine and check with your doctor right away if you start having headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using this medicine.

This medicine may cause nausea, vomiting, constipation, 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).

Bortezomib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Velcade Side Effects

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.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • confusion
  • cough
  • cough producing mucus
  • decreased urination
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • ear congestion
  • fainting
  • fever
  • headache
  • increase in heart rate
  • loss of voice
  • lower back or side pain
  • nerve pain
  • painful blisters on the trunk of the body
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid breathing
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • stuffy nose
  • sunken eyes
  • sweating
  • swollen glands
  • thirst
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • wheezing
  • wrinkled skin
Less common
  • Decreased urine output
  • dilated neck veins
  • general feeling of discomfort or illness
  • increased sensitivity to pain
  • increased sensitivity to touch
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • thickening of bronchial secretions
  • tingling in the hands and feet
  • troubled breathing
  • unsteadiness or awkwardness
  • weight gain
Incidence not known
  • Abdominal or stomach pain and tenderness
  • agitation
  • back pain
  • blistering, peeling, or loosening of the skin
  • bloating
  • bruising
  • change in consciousness
  • coma
  • coughing or vomiting blood
  • dark urine
  • deafness
  • deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
  • diarrhea
  • drowsiness
  • fast heartbeat
  • fear or nervousness
  • general tiredness and weakness
  • hallucinations
  • irritability
  • itching
  • light-colored stools
  • loss of consciousness
  • mood or mental changes
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pounding, slow heartbeat
  • rectal bleeding
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shaking
  • stiff neck
  • trouble sleeping
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bone pain
  • constipation
  • difficulty having a bowel movement
  • difficulty with moving
  • feeling unusually cold or shivering
  • general feeling of discomfort or illness
  • heartburn
  • indigestion
  • itching skin
  • loss of appetite
  • loss of taste
  • mental depression
  • muscle cramps
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pain in the limb
  • rash
  • sleeplessness
  • stomach discomfort or upset, or pain
  • swelling
  • swollen joints
  • unable to sleep
  • vomiting
  • weight loss

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

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

See also: Side effects (in more detail)

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