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

Ninlaro is used in adults to treat multiple myeloma (bone marrow cancer), in combination chemotherapy with lenalidomide and dexamethasone.

This combination is usually given after treatment with at least one other cancer medicine has failed.

Ninlaro should not be used to treat people who are receiving maintenance treatment, or who have been newly diagnosed with multiple myeloma, except if they are participants in a controlled clinical trial.

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.

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.

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 ever had:

• liver disease; or

• kidney disease (or if you are on dialysis).

Ixazomib may harm an unborn baby. Both men and women should use effective birth control to prevent pregnancy while taking Ninlaro, and for at least 90 days after the last dose.

If you are a woman also taking dexamethasone: If you use birth control pills or other hormonal contraception (injections, implants, skin patches, vaginal rings), also use a barrier form of birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Ninlaro is used together with lenalidomide. Do not use Ninlaro with lenalidomide if you are pregnant, or if you are a man and your sex 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.

Carefully follow all instructions about the use 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.

Do not breastfeed while using Ninlaro, and for at least 90 days after your last dose.

Take Ninlaro exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

If you've ever had chickenpox or shingles, taking Ninlaro can cause this virus to become active again. You may be given antiviral medication to prevent shingles.

Carefully follow your doctor's dosing instructions for taking all your medications.

Take Ninlaro at the same time each day 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.

Swallow the Ninlaro capsule whole and do not crush, chew, break, or open it. Take with a full glass of water.

If you vomit shortly after taking Ninlaro, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

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

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.

Usual Adult Dose for Multiple Myeloma:

Starting dose: 4 mg orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Limitations of Use: This drug is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.
-The recommended starting dose of lenalidomide is 25 mg orally daily on Days 1 through 21 of a 28-day treatment cycle; the recommended starting dose of dexamethasone is 40 mg orally on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
-The manufacturer product information for lenalidomide and dexamethasone should each be consulted.

Use: In combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy

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 ever had:

• liver disease; or

• kidney disease (or if you are on dialysis).

Ixazomib may harm an unborn baby. Both men and women should use effective birth control to prevent pregnancy while taking Ninlaro, and for at least 90 days after the last dose.

If you are a woman also taking dexamethasone: If you use birth control pills or other hormonal contraception (injections, implants, skin patches, vaginal rings), also use a barrier form of birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Ninlaro is used together with lenalidomide. Do not use Ninlaro with lenalidomide if you are pregnant, or if you are a man and your sex 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.

Carefully follow all instructions about the use 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.

Do not breastfeed while using Ninlaro, and for at least 90 days after your last dose.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 72 hours (3 days). Do not take two doses at one time.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Ninlaro (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, mouth sores, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Ixazomib can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

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

• a new or worsening skin rash;

• blurred vision, dry or red eyes;

• back pain;

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

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

• low levels of platelets in your blood - easy bruising, unusual bleeding, purple or red spots under your skin;

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

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

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

Common Ninlaro side effects may include:

• nerve problems or swelling in your hands or feet;

• low blood platelets;

• 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.

Other drugs may interact with ixazomib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.