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 alone to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) multiple myeloma (a type of bone marrow cancer) in patients who have received 1 or more previous treatments.

Carfilzomib injection is also used together with other medicines (eg, dexamethasone, daratumumab and dexamethasone, lenalidomide and dexamethasone, daratumumab and hyaluronidase-fihj and dexamethasone, and isatuximab and dexamethasone) to treat relapsed or refractory multiple myeloma in patients who have received 1 to 3 previous treatments.

Carfilzomib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

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 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. However, elderly patients are more likely to have heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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 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
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• 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:

• Angina (chest pain) or
• Blood clots or
• Congestive heart failure or
• Deep vein thrombosis (blood clot in the leg) or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Hypertension (high blood pressure) or
• Interstitial lung disease or
• Kidney disease (eg, patients on dialysis) or
• Liver disease or
• Lung or breathing problems or
• Nerve problems or
• Pneumonitis (lung inflammation) or
• Pulmonary edema (lung disease) or
• Pulmonary embolism (blood clot in the lung) or
• Pulmonary hypertension (lung disease) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Dehydration or
• Electrolyte imbalance—Use with caution. May cause side effects to become worse.

• Herpes zoster—May cause infection to come back (reactivate).

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer clinic. It is given through a needle placed into a vein. This medicine must be given slowly, so the needle will have to stay in place for 10 to 30 minutes.

This medicine needs to be given on a fixed schedule (eg, once or two times a week). 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 may also receive other medicines (eg, dexamethasone, antivirals, medicines to prevent blood clots) to help prevent unwanted reactions to the injection and decrease the risk of virus infection (eg, herpes zoster) reactivation.

Precautions While Using This Medicine:

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.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think a pregnancy has occurred while receiving this medicine, tell your doctor right away.

This medicine may cause serious heart problems (eg, congestive heart failure, heart attack). Tell your doctor right away if you have chest pain or tightness, decrease in the amount of urine, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain while you are receiving this medicine.

Check with your doctor right away if you have a bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem (eg, kidney failure).

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.

Serious lung or breathing problems may occur after you get a shot of this medicine into one of your veins. Call your doctor right away if have any changes in your breathing after you receive this medicine.

Your blood pressure might get too high while you are receiving this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Blood clots may occur while you are receiving this medicine. Tell your doctor right away if you have chest pain, dizziness or lightheadedness, fainting, fast heartbeat, pain, redness, or swelling in the arm or legs, or trouble breathing.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, joint pain, muscle pain or stiffness, difficulty in moving, nausea, vomiting, or sweating while you are receiving this medicine.

This medicine can lower the number of platelets in your blood, which are needed for blood clotting. This may cause serious bleeding problems. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, or pinpoint red spots on your skin.

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 have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem, called posterior reversible encephalopathy syndrome (PRES).

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Call your doctor right away if you have back pain, blurred vision, confusion, dizziness drowsiness, fever, headache, seizures, or unusual tiredness or weakness.

This medicine may cause some people to become dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 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

Agitation

black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

confusion

cough

decreased awareness or responsiveness

decreased urine output

depression

difficult or labored breathing

difficulty with moving

dizziness

drowsiness

fast, slow, or irregular heartbeat

headache

hoarseness

hostility

irritability

loss of consciousness

lower back or side pain

muscle spasms (tetany) or twitching

nausea

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

rapid weight gain

seizures

severe sleepiness

tingling of the hands or feet

trembling

trouble breathing

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual weight gain or loss

vomiting

Less common

Chills

continuing ringing, buzzing, or other unexplained noise in the ears

fever

hearing loss

muscle pain or cramps

painful blisters on the trunk of the body

weakness in the arms, hands, legs, or feet

Rare

Dark urine

general feeling of discomfort or illness

light-colored stools

stomach pain, continuing

thickening of bronchial secretions

yellow eyes or skin

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blindness

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

fainting

joint pain, stiffness, or swelling

stomach pain

sweating

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

Back pain

body aches or pain

bone pain

constipation

diarrhea

dry mouth

ear congestion

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

loss of appetite

loss of voice

metallic taste

muscle weakness

pain in the arms or legs

runny or stuffy nose

sneezing

sore throat

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.