Ninlaro

Read the Patient Information Leaflet if available from your pharmacist before you start taking ixazomib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth at least 1 hour before or 2 hours after food as directed by your doctor, usually once a week for 3 weeks, then stopping the medication for 1 week. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor. Swallow the medication whole with water. Do not crush, chew, or open the capsules.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time.

The dosage is based on your medical condition, lab tests, and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time and day of the week on the weeks you take the medication.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If a capsule breaks, avoid skin and eye contact with the contents of the capsule. If the contents of the capsule get on the skin, wash the area with plenty of water and soap. If the contents of the capsule get in the eyes, flush the eyes with plenty of water.

Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Before taking ixazomib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking ixazomib. Ixazomib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 90 days after the last dose. Women should also ask about using additional reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) if they are using hormonal birth control (such as birth control pills). If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 90 days after the last dose. Consult your doctor before breastfeeding.

Diarrhea, nausea/vomiting, constipation, dry eyes, blurred vision, or eye redness/itching/discharge may occur. Nausea, vomiting, and diarrhea can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, and diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help lessen the nausea and vomiting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever, chills), shingles skin rash/pain (herpes zoster), numbness/tingling of arms/legs, swelling hands/ankles/feet, sudden/unexplained weight gain, symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

This medication can rarely cause serious blood clots and damage to small blood vessels in your body, especially in the kidney and brain. Get medical help right away if you develop symptoms such as unusual tiredness or change in the amount of urine.

Ixazomib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of ixazomib from your body, which may affect how ixazomib works. Examples include rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is within 72 hours (3 days) of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.