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Class: Biological Therapy

Generic Name: ixazomib

Trade Name: Ninlaro®

How is Ninlaro used? Ninlaro is approved to treat multiple myeloma in combination with lenalidomide and dexamethasone in patients who have been treated with at least one prior therapy.

What is the mechanism of action? Ninlaro is a type of targeted drug known as a proteasome inhibitor. By interfering with certain signaling pathways within cells, Ninlaro reduces the growth and survival of cancer cells.

How is Ninlaro given (administered)? Ninlaro is taken orally at least one hour before or two hours after food. You should take Ninlaro once a week on the same day and at approximately the same time for the first 3 weeks of a 4 week cycle as prescribed by your doctor. Do not take Ninlaro and dexamethasone at the same time. Ninlaro should be swallowed whole with water. Avoid contact with the capsule content; if you come in contact with the capsule content wash your skin thoroughly with soap and water. If you miss a dose of Ninlaro, take the missed dose as long as the next scheduled dose is in 3 days or more.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Ninlaro. Typically, blood will be drawn to check levels of blood cells and platelets and to monitor functions of some organ systems, such as the kidney or liver. Patients will also be monitored for gastrointestinal toxicities, peripheral neuropathy, peripheral edema, and rash. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Ninlaro?

  • Diarrhea
  • Constipation
  • Decrease in platelets (thrombocytopenia)
  • Peripheral neuropathy
  • Nausea
  • Peripheral edema (swelling)
  • Vomiting
  • Back pain
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This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to your healthcare provider’s instructions and inform your doctor of any side effects.
  • Take Ninlaro exactly as prescribed.
  • Maintain adequate rest and nutrition.
  • Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician about all medical conditions including liver or kidney problems.
  • Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
  • Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. Ninlaro can harm an unborn baby.
  • Avoid strong CYP3A inducers while being treated with Ninlaro.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience any of the following: persistent nausea, vomiting, diarrhea or constipation; new or worsening symptoms of peripheral neuropathy; unusual swelling of extremities or weight gain due to swelling; new or worsening rash; jaundice or right upper quadrant abdominal pain.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.