Kyprolis

1 What is Kyprolis?

Brand: Kyprolis

Generic: Carfilzomib (injection)

Kyprolis is used alone or together with other medicines 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 given only by or under the supervision of your doctor. This product is available in the powder for solution form.

2 What to Know Before Using

Before using Kyprolis, you must know all about the risks and complications associated with it.

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 healthcare 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 Population: 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.

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

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. 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:

3 Proper Usage

To use Kyprolis properly, you must follow all instructions given by your doctor.

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 into 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.

4 Precautions to Take

Before using Kyprolis, there are some precautions you must take.

It is very important that your doctor checks you at regular visits while you are receiving this medicine to make sure that the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Pregnancy: 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.

Heart problems: 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.

Kidney problems: Kidney problems may occur while you are receiving this medicine. Tell your doctor if you have the following symptoms: agitation, confusion, decreased urine output, depression, headache, rapid weight gain, swelling the face, ankles, or hands, or unusual tiredness or weakness.

Tumor lysis syndrome: 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.

Blood clots: 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, sudden shortness of breath, trouble breathing.

Dizziness: 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.

Allergic reactions: 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.

Platelets: This can lower the number of your platelets, which are necessary for proper blood clotting. Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, or pinpoint red spots on your skin while receiving this medicine.

Liver Problems: 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.

Posterior reversible encephalopathy syndrome (PRES): Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of posterior reversible encephalopathy syndrome (PRES).

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Kyprolis.

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
  • coma
  • confusion
  • a cough or hoarseness
  • decreased urine output
  • depression
  • difficult or labored breathing
  • the difficulty with moving
  • dizziness
  • drowsiness
  • fast or irregular heartbeat
  • headache
  • hostility
  • irregular heartbeat
  • irritability
  • lethargy
  • 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
  • pounding in the ears
  • rapid weight gain
  • seizures
  • slow or fast heartbeat
  • stupor
  • 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 gains or loss

Less common:

  • chills
  • fever
  • muscle pain or cramps
  • painful blisters on the trunk of the body
  • weakness in the arms, hands, legs, or feet

Rare:

  • dark-colored urine
  • the general feeling of discomfort or illness
  • the general feeling of tiredness or weakness
  • light-colored stools
  • stomach pain, continuing
  • thickening of bronchial secretions
  • yellow eyes or skin

Incidence not known:

  • blindness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • joint pain, stiffness, or swelling
  • seizures
  • 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 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.

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