Pronunciation:

bore-TEZ-oh-mib

Brand Names:

• Velcade

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Proteasome Inhibitor

Uses of This Medicine:

Bortezomib belongs to the general group of medicines known as antineoplastics. It is used to treat multiple myeloma and mantle cell lymphoma in patients who have received at least one treatment that has not helped .

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 may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Bortezomib is to be administered 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 in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of bortezomib 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.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Dehydration or
• Syncope, history of—May cause orthostatic/postural hypotension.

• Heart disease—Bortezomib may make your heart problems worse or cause new heart problems. Your doctor will watch for this side effect.

• Liver disease—Higher blood levels of bortezomib may result and a smaller dose may be needed.

• Lung disease or
• Peripheral neuropathy—Bortezomib may make the symptoms worse or cause new symptoms .

• Tumor lysis syndrome, risk of—Bortezomib may increase your chance of getting this side effect. Your doctor will watch for this side effect.

Proper Use of This Medicine:

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 .

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 .

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

This medicine may cause vomiting 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).

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

Make sure your doctor knows if you are pregnant or breastfeeding. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. This may be symptoms of a condition called peripheral neuropathy .

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 .

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 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 .

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 immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in 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

decreased urination

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

dry mouth

ear congestion

fainting

fever

headache

increase in heart rate

loss of voice

lower back or side pain

nasal congestion

pale skin

painful blisters on trunk of body

painful or difficult urination

pinpoint red spots on skin

rapid breathing

runny nose

shortness of breath

sneezing

sore throat

sunken eyes

sweating

thirst

tightness in chest

troubled breathing with exertion

ulcers, sores, or white spots in mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

weakness in 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 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 pain and tenderness

agitation

back pain

blistering, peeling, loosening of 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 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 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 irritated eyes

red skin lesions, often with a purple center

restlessness

seeing, hearing, or feeling things that are not there

seizures

shaking

stiff neck

trouble sleeping

upper right abdominal pain

yellow eyes or skin

Symptoms of overdose

If you think you or someone else may have taken an overdose get emergency help at once.

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 in moving

fatigue

feeling unusually cold; shivering

heartburn

indigestion

itching skin

loss of appetite

loss of taste

malaise

mental depression

muscle cramps

muscle pain or stiffness

nausea

pain in joints

pain in limb

rash

sleeplessness

stomach discomfort, 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.