Carfilzomib Injection

WHY is this medicine prescribed?

Carfilzomib injection is used alone and in combination with other medications to treat people with multiple myeloma (a type of cancer of the bone marrow) who have already been treated with other medications. Carfilzomib is in a class of medications called proteasome inhibitors. It works by stopping or slowing the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Carfilzomib comes as a powder to be mixed with liquid to be injected intravenously (into a vein). Carfilzomib is given by a doctor or nurse in a medical office or clinic usually over a period of 10 or 30 minutes. It may be given 2 days in a row each week for 3 weeks followed by a 12-day rest period or it may be given once a week for 3 weeks followed by a 13-day rest period. The length of treatment will depend on how well your body responds to the medication.

Carfilzomib injection may cause severe or life-threatening reactions for up to 24 hours after you receive a dose of the medication. You will receive certain medications to help prevent a reaction before you receive each dose of carfilzomib. Tell your doctor immediately if you experience any of these symptoms after your treatment: fever, chills, joint or muscle pain, flushing or swelling of the face, swelling or tightening of the throat, vomiting, weakness, shortness of breath, dizziness or fainting, or chest tightness or pain.

Be sure to tell your doctor how you are feeling during your treatment. Your doctor may stop your treatment for a while or decrease your dose of carfilzomib if you experience side effects of the medication.

What SPECIAL PRECAUTIONS should I follow?

Before receiving carfilzomib injection,

• tell your doctor and pharmacist if you are allergic to carfilzomib, any other medications, or any of the ingredients in carfilzomib injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had heart failure, a heart attack, irregular heartbeat, or other heart problems; high blood pressure; a herpes infection (cold sores, shingles, or genital sores); or seizures or any other neurologic disorder. Also tell your doctor if you have liver or kidney disease or are on dialysis.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving carfilzomib. If you are female, you must take a pregnancy test before starting treatment and should use birth control to prevent pregnancy during your treatment with carfilzomib and for 6 months after your final dose. If you are a male, you and your partner should use birth control methods to prevent pregnancy during your treatment with carfilzomib and for 3 months after your final dose. If you or your partner become pregnant while receiving this medication, call your doctor. Carfilzomib may harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed while you are receiving carfilzomib injection and for 2 weeks after your final dose.

• you should know that carfilzomib may make you drowsy, dizzy, or lightheaded, or cause fainting. Do not drive or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Drink plenty of fluids before and every day during your treatment with carfilzomib, especially if you vomit or have diarrhea.

What SIDE EFFECTS can this medicine cause?

Carfilzomib injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• constipation
• muscle spasm
• pain in the arms or legs; back pain
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW and SPECIAL PRECAUTIONS sections, call your doctor:

• cough
• dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration
• swelling of the feet of legs
• pain, tenderness, or redness in one leg
• shortness of breath or difficulty breathing
• chest pain
• pain, burning, numbness, or tingling in the hands or feet
• nausea
• unusual tiredness or weakness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• bloody or black, tarry stools
• rash of pinpoint-sized reddish-purple spots, usually on the lower legs
• blood in the urine
• decreased urination
• seizures
• vision changes or loss of vision
• confusion, memory loss, dizziness or loss of balance, difficulty talking or walking, changes in vision, decreased strength or weakness on one side of the body

Carfilzomib injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• chills
• dizziness
• decreased urination

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure regularly and order certain tests to check your body's response to carfilzomib.

Ask your pharmacist any questions you have about carfilzomib injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.