Class: Biological Therapy

Generic Name: Ixazomib

Trade Name: Ninlaro®

For which conditions is this drug approved? Ninlaro is approved for use in combination with the medicines Revlimid® (lenalidomide) and dexamethasone to treat people with multiple myeloma who have received at least one prior treatment.

What is the mechanism of action? Ninlaro is a type of drug known as a proteasome inhibitor. It works by blocking enzymes from multiple myeloma cells to make it difficult for them to grow and survive.

How is Ninlaro typically given (administered)? You will take Ninlaro by mouth (orally) during 28-day periods, or “cycles.” Your doctor will give you a schedule for taking Ninlaro and tell you how many cycles you need to take. Your doctor will also tell you how to take Revlimid® and dexamethasone while you are taking Ninlaro.

How are patients typically monitored?

Your healthcare provider will do blood tests during treatment with Ninlaro to check for low platelet counts (thrombocytopenia) and to check your liver function. Your doctor will also monitor you for gastrointestinal complications (severe diarrhea, constipation, nausea, and vomiting), peripheral neuropathy (weakness, numbness, and pain, usually in the hands and feet), peripheral edema (accumulation of fluid causing swelling), and skin reactions.

What are the common (occur in 30% or more of patients) side effects of treatment with Ninlaro?

• Diarrhea
• Constipation
• Nausea
• Vomiting
• Thrombocytopenia
• Neutropenia (low white blood cell count)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Ninlaro?

• Upper respiratory tract infection
• Peripheral neuropathy
• Back pain
• Peripheral edema

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?

• Take Ninlaro exactly as your doctor prescribes it. This includes taking Ninlaro once a week on the same day and at approximately the same time for the first three weeks of a four-week cycle.
• Swallow each Ninlaro capsule whole. Do not crush, chew, or open it.
• Take Ninlaro at least one hour before or at least two hours after food.
• If the capsule breaks, avoid direct contact with the contents of the capsule. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water.
• On the days that you take both Ninlaro and dexamethasone, do not take Ninlaro and dexamethasone at the same time. Take dexamethasone with food.
• If you miss a dose, you can take the missed dose as long as the next scheduled dose is at least 72 hours away. Do not to take a missed dose if it is within 72 hours of your next scheduled dose.
• If you vomit after taking a dose of Ninlaro, do not repeat the dose. Do resume dosing at the time of the next scheduled dose.
• Tell your doctor about all of your medical conditions, especially if you have liver problems or kidney problems or are on dialysis.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before starting any new medicines during treatment with Ninlaro.

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

• Avoid becoming pregnant while you are taking Ninlaro. Ninlaro may harm your unborn baby.
• Females who are able to become pregnant must use effective birth control during treatment with Ninlaro and for 90 days after their final dose.
• Males with a female partner who is able to become pregnant must use effective birth control during treatment and for 90 days after their final dose of Ninlaro.

 When should patients notify their physician?

• If you take more Ninlaro than your healthcare provider tells you to take, call your healthcare provider right away or go to the nearest hospital emergency room.
• Tell your doctor if you have signs of thrombocytopenia. These include bleeding and easy bruising.
• Tell your doctor if you have signs of stomach and intestinal (gastrointestinal) problems. These include diarrhea, constipation, nausea, and vomiting.
• Tell your doctor if you have signs nerve problems. These include: tingling, a burning feeling in your feet or hands, numbness, weakness in your arms or legs, and pain.
• Tell your doctor if you experience severe swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
• Tell your doctor if you have skin reactions, including a new or worsening rash.
• Tell your doctor if you have signs of liver problems. These include yellowing of your skin or the whites of your eyes and pain in your right upper stomach-area.

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.