ixazomib

What is the most important information I should know about ixazomib?

What is ixazomib?

Ixazomib is used in adults to treat multiple myeloma (bone marrow cancer), in combination chemotherapy with lenalidomide and dexamethasone.

This combination is usually given after treatment with at least one other cancer medicine has failed.

Ixazomib should not be used to treat people who are receiving maintenance treatment, or who have been newly diagnosed with multiple myeloma, except if they are participants in a controlled clinical trial.

Ixazomib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ixazomib?

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease (or if you are on dialysis).

If you are a woman also taking dexamethasone: If you use birth control pills or other hormonal contraception (injections, implants, skin patches, vaginal rings), also use a barrier form of birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

How should I take ixazomib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your combination chemotherapy will be given in a 28-day treatment cycle. You will take ixazomib once per week on the same day of the week during the first 3 weeks of each cycle. Your other medicines may be taken daily or only once per week throughout the cycle.

If you've ever had chickenpox or shingles, taking ixazomib can cause this virus to become active again. You may be given antiviral medication to prevent shingles.

Carefully follow your doctor's dosing instructions for taking all your medications.

Do not take your dexamethasone dose at the same time you take ixazomib. Dexamethasone should be taken with food and ixazomib should be taken without food.

If you vomit shortly after taking ixazomib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 72 hours (3 days). Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking ixazomib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ixazomib?

• severe ongoing nausea, vomiting, diarrhea, or constipation;
• a new or worsening skin rash;
• blurred vision, dry or red eyes;
• back pain;
• fluid retention --swelling in your hands or feet, rapid weight gain;
• liver problems --upper stomach pain, jaundice (yellowing of the skin or eyes);
• low levels of platelets in your blood --easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts --fever, cold or flu symptoms, cough, sore throat, swollen gums, mouth sores, skin sores;
• nerve problems --numbness, tingling, pain, burning feeling in your hands or feet, weakness in your arms or legs; or
• signs of shingles --flu-like symptoms, tingly or painful blistering rash on one side of your body.

Common side effects may include:

• nerve problems or swelling in your hands or feet;
• low blood platelets;
• diarrhea, constipation;
• nausea, vomiting; or
• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ixazomib?

Other drugs may affect ixazomib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ixazomib.