Multiple Myeloma Drug Side Effects & Dosage

What is Ninlaro (ixazomib), and how does it work?

Ninlaro is used with two other prescription medicines called Revlimid (lenalidomide) and dexamethasone. Read the Medication Guide that comes with Revlimid (lenalidomide). You can ask your healthcare provider or pharmacist for information about dexamethasone.

Ninlaro is a prescription medicine used to treat multiple myeloma in
combination with the medicines Revlimid (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

It is not known if Ninlaro is safe and effective in children.

Before taking Ninlaro, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have kidney problems or are on dialysis
• are pregnant or plan to become pregnant. Ninlaro can harm your unborn baby.

What are the side effects of Ninlaro?

Ninlaro may cause serious side effects, including:

• Low platelet counts (thrombocytopenia). Low platelet counts are common with Ninlaro, and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
• Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with Ninlaro, and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with Ninlaro. Your healthcare provider may prescribe medicine to help treat your symptoms.
• Nerve problems. Nerve problems are common with Ninlaro and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms, including:
  • tingling
  • numbness
  • pain
  • a burning feeling in your feet or hands
  • weakness in your arms or legs
• Swelling. Swelling is common with Ninlaro and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
• Skin reactions. Tell your healthcare provider if you get a new or worsening rash.
• Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with Ninlaro:
• Liver problems. Tell your healthcare provider if you get these signs of a liver problem:
  • yellowing of your skin or the whites of your eyes
  • pain in your right upper stomach-area

Other common side effects have occurred. Tell your healthcare provider if you get new or worsening signs or symptoms of the following:

These are not all the possible side effects of Ninlaro. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Ninlaro?

• Take Ninlaro exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ninlaro without talking to your healthcare provider first.
• Ninlaro is taken in “cycles.” Each cycle lasts 4 weeks (28 days).
  • The usual dose of Ninlaro is 1 capsule taken 1 time each week, on the same day of the week for the first 3 weeks of each cycle.
  • Take each dose of Ninlaro at about the same time of day.
  • Take REVLIMID (lenalidomide) and dexamethasone exactly as your healthcare provider tells you to.
  • Your healthcare provider will do blood tests during treatment with Ninlaro to check for side effects.
  • Your healthcare provider may change your dose or stop Ninlaro, REVLIMID (lenalidomide), or dexamethasone if you have side effects.
• Take Ninlaro at least 1 hour before or at least 2 hours after food.
• On the days that you take both Ninlaro and dexamethasone, do not take Ninlaro and dexamethasone at the same time. Take dexamethasone with food.
• Swallow Ninlaro capsules whole with water. Do not crush, chew or open the capsule.
• Avoid direct contact with the capsule contents. If you accidentally get powder from the Ninlaro capsule on your skin, wash the area well with soap and water. If you accidentally get powder from the Ninlaro capsule in your eyes, flush your eyes well with water.
• If you miss a dose of Ninlaro, or if you are late taking a dose, take the dose as long as the next scheduled dose is more than 3 days (72 hours) away. Do not take a missed dose of Ninlaro if it is within 3 days (72 hours) of your next scheduled dose.
• If you vomit after taking a dose of Ninlaro, do not repeat the dose. Take your next dose of Ninlaro on the next scheduled day and time.
• Your doctor may prescribe a medicine to take with Ninlaro to decrease the risk of the chicken pox virus (herpes zoster) coming back (reactivation).
• 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.

What drugs interact with Ninlaro?

Strong CYP3A Inducers

Avoid concomitant administration of Ninlaro with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort).

Is Ninlaro safe to take while pregnant or breastfeeding?

• Females who are able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro. If using hormonal contraceptives (for example, the pill), an additional barrier method of contraception (for example, diaphragm or condom) must be used.
• Males with a female partner who is able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro.
• Talk to your healthcare provider about birth control methods that may be right for you.
• Tell your healthcare provider right away if you or your partner become pregnant while you are receiving Ninlaro.
• Tell your healthcare provider right away if you are breastfeeding or plan to breastfeed. It is not known if Ninlaro passes into breast milk, if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with Ninlaro and for 90 days after your final dose of Ninlaro.