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Carfilzomib (Intravenous route)

Pronunciation:

kar-FILZ-oh-mib

Brand Names:

  • Kyprolis

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Proteasome Inhibitor

Uses of This Medicine:

Carfilzomib injection is used to treat multiple myeloma (a type of bone marrow cancer) in patients who have received at least 2 prior treatments that did not work well. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Carfilzomib is an antineoplastic agent (cancer medicine).

This medicine 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 carfilzomib 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 carfilzomib 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. 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:

  • Breathing problems (eg, shortness of breath) or
  • Congestive heart failure or
  • Heart disease (eg, angina) or
  • Kidney disease or
  • Liver disease or
  • Neutropenia (low white blood cells) or
  • Peripheral neuropathy (a nerve problem) or
  • Pulmonary hypertension (a lung disease) or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Herpes zoster (shingles), history of—May reactivate this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in a vein.

This medicine needs to be given on a fixed schedule. Be sure to keep all appointments.

Drink extra fluids so you will pass more urine while you are receiving this medicine. This may help prevent kidney problems and other unwanted effects.

You might also receive medicines (eg, dexamethasone) to help prevent unwanted reactions to the injection.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits while you are receiving this medicine to make sure that the 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.

This medicine may cause serious heart problems. Tell your doctor right away if you have chest pain or discomfort, shortness of breath, irregular heartbeats, or swelling of the feet, ankles, or legs while you are receiving this medicine.

This medicine may cause you to be more dizzy, lightheaded, or tired than normal. 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. Getting up slowly from a sitting or lying position may help prevent lightheadedness or dizziness. Tell your doctor if you feel dizzy or lightheaded.

This medicine may cause a serious type of allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, chest tightness, trouble breathing, swelling in your face or hands, a fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.

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, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or feel tired.

Carfilzomib 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.

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.

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.

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
Agitation
black, tarry stools
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine or stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
confusion
cough or hoarseness
decreased urine output
depression
difficult or labored breathing
difficulty with moving
dizziness
drowsiness
fast or irregular heartbeat
hostility
irregular heartbeat
irritability
lower back or side pain
muscle spasms (tetany) or twitching
nausea or vomiting
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pale skin
pinpoint red spots on the skin
seizures
shortness of breath
stupor
swelling of the face, ankles, or hands
tightness in the chest
tingling of the hands or feet
trembling
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unsteadiness or awkwardness
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
wheezing
Less common
Chills
fever
muscle pain or cramps
pain in the joints
painful blisters on the trunk of the body
weakness in the arms, hands, legs, or feet

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
Abdominal or stomach pain
back pain
blurred vision
body aches or pain
bone pain
constipation
diarrhea
dry mouth
ear congestion
flushed, dry skin
fruit-like breath odor
headache
increased hunger
increased thirst
increased urination
loss of appetite
loss of voice
metallic taste
muscle weakness
pain in the arms or legs
runny nose
sneezing
sore throat
sweating
trouble sleeping
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: 4/4/2014

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