Ixazomib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat multiple myeloma, along with 2 other medicines. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy; proteasome inhibitor

Generic and brand names: ixazomib, oral; Ninlaro

What is this medicine used for?

This medicine is taken by mouth to treat multiple myeloma in people who have already been treated with other types of chemotherapy and have not shown improvement. It is given along with 2 other medicines, lenalidomide and dexamethasone. Before taking this medicine, you must be enrolled in a special program for lenalidomide.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 90 days after you finish treatment. Talk with your healthcare provider about birth control methods that may be right for you. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

Males: Use an effective birth control method while you are taking this medicine and for 90 days after stopping it. Talk with your healthcare provider about effective birth control.

How do I use it?

If you are also taking lenalidomide, read the Medication Guide that comes in the medicine package when you start taking the medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under 18.

Take this medicine at least 1 hour before or 2 hours after you have food. This medicine is taken 1 time each week, on the same day for the first 3 weeks of each 4 week cycle, and at about the same time on that day. Swallow the capsule whole, with water. Do not open, crush, or chew the capsules. If the contents of the capsule touch your skin, wash thoroughly with soap and water. If contents of the capsule get in your eyes, flush them with plenty of water.

On the days that you also take dexamethasone, do not take this medicine and dexamethasone at the same time. Take dexamethasone with food.

If you vomit after taking a dose of this medicine, do not repeat the dose. Take your next dose on the next scheduled day and time.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 72 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine lowers the number of certain types of blood cells in your body. As a result, you may bleed or get infections more easily. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you have any signs of infection, or any unusual bruising or bleeding. Also, do not have any vaccines without getting your healthcare provider's approval first.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reactions (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing)

Serious (Report these to your healthcare provider right away.): Numbness, tingling, burning, pain, or weakness in your arms, hands, feet, or legs; unexplained swelling in your arms, hands, legs, ankles, or feet, or unexplained weight gain; unusual bruising or bleeding; shortness of breath; unexplained fever, sore throat, cough, or mouth sores; dark urine; light-colored bowel movements; yellowing of the skin or eyes; severe stomach pain, diarrhea, constipation, nausea, or vomiting; new or worsening rash; vision changes, blurred vision, or eye pain.

Other: Back pain; nausea; diarrhea; constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Bosentan (Tracleer)
• Cancer medicines such as dabrafenib (Tafinlar), enzalutamide (Xtandi), and mitotane (Lysodren)
• Efavirenz (Sustiva)
• Lumacaftor/ivacaftor (Orkambi)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Many medicines may interact with lenalidomide and dexamethasone. Talk with your healthcare provider about this if you are also taking lenalidomide and dexamethasone.

Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the original package. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.