Ixazomib (ix-AZ-oh-mib)

Treats multiple myeloma.

Brand Name(s):

Ninlaro

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at the same time and on the same day of the week every week for the first 3 weeks. Take it at least 1 hour before or at least 2 hours after food.
• Swallow the capsule whole with water. Do not open, crush, or chew it.
• Do not handle crushed or broken capsules. Wash your skin with soap and water if the powder from inside the capsule touches your skin. If the medicine gets into your eyes, rinse them with water.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If your next regular dose is more than 72 hours away, take your medicine as soon as you can. If your next dose is less than 72 hours away, wait until then to take your medicine and skip the missed dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking your dose, do not take more medicine. Just take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package until you are ready to use it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ixazomib works. Tell your doctor if you are using carbamazepine, phenytoin, rifampin, or St John's wort.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective birth control during treatment and for 90 days after the last dose to keep from getting pregnant. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 90 days after the last dose.
• Do not breastfeed during treatment and for at least 90 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or heart disease.
• This medicine may cause the following problems:
  • Nerve problems, including peripheral neuropathy
  • Fluid retention (edema)
  • Skin reactions
  • Thrombotic microangiopathy (damage in the smallest blood vessels)
  • Liver problem
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Fever, tiredness, confusion, loss of vision, seizures
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe or ongoing diarrhea, nausea, vomiting, constipation
• Unusual bleeding, bruising, or weakness
• Weakness in the arms, hands, legs, or feet

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Mild diarrhea, vomiting, constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088