Description
Bortezomib injection is used to treat multiple myeloma (blood plasma cell cancer) in patients with or without a previous history of treatment, and mantle cell lymphoma.
Bortezomib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are 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 direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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 in children with relapsed acute lymphoblastic leukemia (ALL).
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bortezomib injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine, Live
- Zoster Vaccine, Live
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Apalutamide
- Bacillus of Calmette and Guerin Vaccine, Live
- Carbamazepine
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Enzalutamide
- Fosphenytoin
- Influenza Virus Vaccine, Live
- Itraconazole
- Levoketoconazole
- Lumacaftor
- Methotrexate
- Mitotane
- Phenytoin
- Poliovirus Vaccine, Live
- Rifampin
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- St John's Wort
- Typhoid Vaccine, Live
- Yellow Fever Vaccine
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
- Diabetes or
- Heart disease or
- Hypotension (low blood pressure) 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 cause infection to come back (reactivate).
- 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
Medicines used to treat cancer are very strong and can have many side effects. 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.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins or as a shot under your skin (usually in the abdomen or thighs).
You may receive medicines to help prevent nausea, vomiting, or diarrhea. Drink extra fluids while you are using this medicine to keep from getting dehydrated. This could also help you avoid feeling dizzy or lightheaded. You may also receive medicines (eg, dexamethasone, melphalan, prednisone, antivirals) to help prevent unwanted reactions to the injection and decrease the risk of virus infection (eg, herpes zoster) reactivation.
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
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving this 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause serious heart problems. Tell your doctor right away if you have chest pain or discomfort, trouble breathing, irregular heartbeat, or swelling of the feet, ankles, or legs while you are receiving this medicine.
Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
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 receiving this medicine.
This medicine may cause nausea, vomiting, constipation, and diarrhea, so it is important to drink plenty of fluids. It may also cause stomach or bowel blockage. 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 reaction, called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, muscle or 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.
Thrombotic microangiopathy (damage in the smallest blood vessels), including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) may occur while you are receiving this medicine. Tell your doctor right away if you have the following symptoms: dark or bloody urine, difficulty speaking, fever, increased or decreased urination, pinpoint red spots on the skin, seizures, stomach pain, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.
If you plan to have children, talk with your doctor before receiving this medicine. Some men and women receiving this medicine have become infertile (unable to have children).
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
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
- 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
- weight gain
Incidence not known
- Agitation
- back pain
- blistering, peeling, or loosening of the skin
- bloating
- bruising
- change in consciousness
- 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
- irritability
- itching
- light-colored stools
- loss of consciousness
- pain 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
- stomach pain and tenderness
- trouble sleeping
- upper right 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
- Belching
- bone pain
- difficulty having a bowel movement
- difficulty with moving
- feeling unusually cold or shivering
- hair loss or thinning of hair
- heartburn
- indigestion
- joint pain or swelling
- loss of appetite
- loss of taste
- mental depression
- muscle cramps
- muscle pain or stiffness
- nausea
- pain in the arms or legs
- rash
- stomach discomfort, upset, or pain
- 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.
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