Ninlaro - Ixazomib Capsules

What is this medication?

IXAZOMIB (ix az oh mib) treats multiple myeloma, a type of bone marrow cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): NINLARO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• An unusual or allergic reaction to ixazomib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label on the same day of each week. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is less than 72 hours before the next dose. If it is less than 72 hours before the next dose, skip the missed dose. Take the next dose at the normal time. If you vomit after taking a dose, skip it. Take the next dose at the normal time.

What may interact with this medication?

• Carbamazepine
• Phenytoin
• Rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while taking this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 90 days after the last dose. Do not father a child while taking this medication and for 90 days after the last dose. Use a condom when having sex during this time period. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication and for 90 days after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pain, tingling, or numbness in the hands or feet
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Swelling of the ankles, hands, or feet
• TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Cough
• Diarrhea
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.