Ixazomib

Ixazomib is used in combination with lenalidomide (Revlimid) and dexamethasone to treat multiple myeloma (cancer of the plasma cells in the bone marrow) that has worsened after treatment with other chemotherapy medications. Ixazomib is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells.

Ixazomib comes as a capsule to take by mouth. It is usually taken with water on an empty stomach, at least 1 hour before or 2 hours after eating. It is taken on days 1,8, and 15 of a 28 day treatment cycle. Take ixazomib at around the same time on every day that you take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ixazomib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take ixazomib and dexamethasone at the same time because you should take dexamethasone with food.

Swallow the capsules whole; do not split, chew, or crush them.

Be careful when handling ixazomib capsules. Do not allow your skin, eyes, mouth, or nose to come into contact with broken or crushed ixazomib capsules. If such contact occurs, wash your skin well with soap and water or rinse your eyes well with plain water.

If you vomit after taking ixazomib, do not repeat the dose. Take your next dose of ixazomib on the next scheduled day that you are supposed to take it.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of ixazomib, or of the other medications that you are taking, depending on the side effects that you experience. Be sure to talk to your doctor about how you are feeling during your treatment. Do not stop taking ixazomib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before taking ixazomib,

• tell your doctor and pharmacist if you are allergic to ixazomib, any other medications, or any of the ingredients in ixazomib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements you are taking or plan to take while taking ixazomib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with ixazomib: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking ixazomib. Do not start this medication while taking ixazomib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant, or plan to father a child. You should not become pregnant while you are taking ixazomib. Use effective birth control during your treatment with ixazomib and for 90 days after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment and for 90 days after your final dose. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while taking ixazomib, call your doctor immediately. Ixazomib can harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking ixazomib.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is within 72 hours (3 days) of your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• diarrhea
• constipation
• nausea
• new or worsening rash
• back pain
• unusual swelling of your arms or legs
• weight gain due to swelling
• blurred vision
• dry eyes
• pink eye

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• nausea
• extreme tiredness
• loss of appetite
• flu-like symptoms
• unusual bleeding or bruising
• yellowing of your skin or eyes
• pain in the upper right part of your stomach
• burning, tingling, numbness, pain, or weakness in arms or legs
• bloody or black, tarry stool

Ixazomib may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Leave the medication in the original packaging until right before you take it.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ixazomib.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Ninlaro^®