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Bortezomib (Intravenous route, subcutaneous route)

Pronunciation:

bor-TEZ-oh-mib

Brand Names:

  • Velcade

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Proteasome Inhibitor

Uses of This Medicine:

Bortezomib injection is used to treat multiple myeloma (blood plasma cell cancer) in patients with or without a prior history of treatment, and mantle cell lymphoma.

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 given only by or under the supervision of your doctor.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Other 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

Other interactions—

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 (eg, 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, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

If you are using this medicine for multiple myeloma, it is important to tell your doctor if you have received bortezomib in the past.

Precautions While Using This Medicine:

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 posterior reversible encephalopathy syndrome (PRES). 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

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
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
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
general tiredness and weakness
hallucinations
irritability
itching
light-colored stools
loss of consciousness
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
difficulty having a bowel movement
difficulty with moving
feeling unusually cold or shivering
general feeling of discomfort or illness
heartburn
indigestion
loss of appetite
loss of taste
mental depression
muscle cramps
muscle pain or stiffness
nausea
pain in the joints
pain in the limb
rash
stomach discomfort or upset, or pain
swelling
swollen joints
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.


Last Updated: 11/4/2014

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