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Ninlaro

Generic Name: ixazomib (ix AZ oh mib)
Brand Names: Ninlaro

What is Ninlaro?

Ninlaro (ixazomib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ninlaro is used to treat multiple myeloma (bone marrow cancer), in combination chemotherapy with lenalidomide and dexamethasone. This combination is usually given after at least one other cancer medicine has been tried without success.

Ninlaro may also be used for purposes not listed in this medication guide.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Do not use Ninlaro with lenalidomide if you are pregnant, or if you are a man and your sexual partner is pregnant. Lenalidomide is known to cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Before taking this medicine

You should not use Ninlaro if you are allergic to ixazomib.

To make sure Ninlaro is safe for you, tell your doctor if you have:

  • liver disease; or

  • kidney disease.

Using Ninlaro during pregnancy could harm the unborn baby. Ninlaro is used together with lenalidomide. Lenalidomide is known to cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects. Do not take Ninlaro with lenalidomide if you are pregnant.

Use effective birth control while you are using Ninlaro and for at least 90 days after your treatment ends. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Carefully follow all instructions about the use of of birth control while using Ninlaro with lenalidomide, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using these medicines.

It is not known whether ixazomib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Ninlaro and for at least 90 days after your last dose.

How should I take Ninlaro?

Take Ninlaro exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your combination chemotherapy will be given in a 28-day treatment cycle. You will take Ninlaro once per week during the first 3 weeks of each cycle. Your other medicines may be taken daily or only once per week.

You may also be given medication to prevent certain side effects of Ninlaro.

Follow your doctor's dosing instructions very carefully. Your doctor will determine how long to treat you with this medicine.

Take Ninlaro on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not take your dexamethasone dose at the same time you take Ninlaro. Dexamethasone should be taken with food and Ninlaro should be taken without food.

Take this medicine with a full glass of water. Do not crush, chew, break, or open the capsule. Swallow it whole.

If you vomit shortly after taking an Ninlaro capsule, do not take another one. Wait until your next scheduled dose and take the regular amount of medicine at that time.

Do not use a broken Ninlaro capsule. The medicine inside the capsule can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat. Do not freeze. Keep each capsule in the blister pack until you are ready to take a dose. Store blister packs in their original carton.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Ninlaro dosing information

Usual Adult Dose for Multiple Myeloma:

This drug is only given in combination with lenalidomide and dexamethasone; consult the manufacturer product information for dosing of lenalidomide and dexamethasone.

Recommended dose: 4 mg orally on Days 1, 8, and 15 of a 28-day cycle

Comments:
-Prior to initiating a new cycle of therapy:
1) Absolute neutrophil count should be at least 1,000/mm3
2) Platelet count should be at least 75,000/mm3
3) Nonhematologic toxicities should, at physician discretion, generally be recovered to patient baseline condition or Grade 1 or lower
-This drug should be taken once a week on the same day and at approximately the same time for the first 3 weeks of a 4 week cycle.
-This drug should be taken at least 1 hour before or at least 2 hours after food.
-The whole capsule should be swallowed with water (not crushed, chewed, or opened)
-If a dose is delayed or missed, the dose should be taken only if the next scheduled dose is 72 or more hours away. A missed dose should not be taken within 72 hours of the next scheduled dose. A double dose should not be taken to make up for the missed dose.
-If vomiting occurs after taking a dose, the patient should not repeat the dose. The patient should resume dosing at the time of the next scheduled dose.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: Treatment of multiple myeloma (in combination with lenalidomide and dexamethasone) in patients who have received at least one prior therapy

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 72 hours (3 days) away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Ninlaro?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Ninlaro side effects

Get emergency medical help if you have signs of an allergic reaction to Ninlaro: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects of Ninlaro may occur. Seek medical attention if you have:

  • muscle weakness, numbness or loss of movement in your legs or feet;

  • headache, confusion, changes in your vision or thinking;

  • a seizure (convulsions);

  • little or no urination;

  • nosebleed, bruising, unusual tiredness; or

  • fast or slow heart rate, feeling light-headed or short of breath.

Call your doctor at once if you have:

  • severe ongoing nausea, vomiting, diarrhea, or constipation;

  • back pain;

  • new or worsening skin rash;

  • blurred vision, dry or red eyes;

  • easy bruising or bleeding;

  • fluid retention - swelling in your hands or feet, rapid weight gain;

  • nerve problems - numbness, tingling, pain, burning feeling in your hands or feet, weakness in your arms or legs;

  • signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body;

  • low white blood cell counts - fever, cold or flu symptoms, cough, sore throat, swollen gums, mouth sores, skin sores;

  • liver problems - upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Ninlaro side effects may include:

  • fluid retention;

  • numbness or tingling, bruising or bleeding;

  • diarrhea, constipation;

  • nausea, vomiting; or

  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Ninlaro?

Other drugs may interact with ixazomib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Ninlaro.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ninlaro only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 1.02.

Date modified: January 10, 2017
Last reviewed: December 08, 2016

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