Information for Nurse Practitioners Treating Patients with NINLARO® (ixazomib)

Resources for nurse practitioners who are providing ongoing support for patients prescribed NINLARO and their caregivers.

Resources for Patient Management

Resources for NINLARO dosing and ongoing management

The importance of long-term* proteasome inhibition in multiple myeloma

*Used herein to refer to treatment to disease progression or unacceptable toxicity.1

Answers to patient FAQs

Who is NINLARO for?​

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 1 prior treatment for their multiple myeloma. NINLARO should not be used to treat people who are receiving maintenance treatment, or people who have been newly diagnosed with multiple myeloma unless they are participants in a controlled clinical trial. It is not known if NINLARO is safe and effective in children.1

What is the NINLARO regimen, and what kind of results were seen in the clinical study?​

The NINLARO regimen is a combination of 3 medicines that you can take at home: NINLARO, REVLIMID® (lenalidomide), and dexamethasone. In the NINLARO study, adding NINLARO to REVLIMID and dexamethasone improved median progression free survival (PFS) by nearly 6 months. The study reported 20.6 months median PFS with the NINLARO regimen and 14.7 months median PFS with the placebo regimen (placebo+lenalidomide+dexamethasone). In this study, the overall survival of patients who received the NINLARO regimen was similar to that of patients who received the placebo regimen.1

What are the possible side effects of NINLARO?​

NINLARO may cause serious side effects, including1:​

  • Low platelet counts (thrombocytopenia) 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 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. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores.
  • 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:
    • fever​
    • bruising​
    • nose bleeds
    • tiredness​
    • decreased urination​
  • 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​ (abdomen)
  • Other common side effects of NINLARO include low white blood cell counts and bronchitis.
  • Tell your healthcare provider if you get new or worsening signs or symptoms of the following during treatment with NINLARO:
    • skin rash and pain (shingles) due to reactivation of the chicken pox virus (herpes zoster)
    • blurred vision or other changes in your vision, dry eye, and pink eye (conjunctivitis)

These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to Takeda at 1-844-217-6468 or FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking NINLARO?

Before taking NINLARO, tell your healthcare provider about all of your medical conditions, including if you1:​

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

Females who are able to become pregnant:

  • Avoid becoming pregnant during treatment with NINLARO.
  • Your healthcare provider will do a pregnancy test before you start treatment with NINLARO.
  • You should use effective non-hormonal birth control during treatment and for 90 days after your last dose of NINLARO. If using hormonal contraceptives (for example, birth control pills), you should also use an additional barrier method of contraception (for example, diaphragm or condom). Talk to your healthcare provider about birth control methods that may be right for you during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with NINLARO.

Males with female partners who are able to become pregnant:

  • You should use effective birth control during treatment and for 90 days after your last dose of NINLARO.
  • Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant while you are being treated with NINLARO.
  • 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.

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.1

For those who responded to treatment in the study, how long did it take to see a response?​

In a clinical trial, the median time that patients experienced their first response was about 1 month with the NINLARO regimen (NINLARO+lenalidomide+dexamethasone), compared with about 2 months with the placebo regimen (placebo+lenalidomide+dexamethasone).1

How long can I take NINLARO?

The NINLARO regimen can be taken until disease worsens or treatment is no longer tolerable.1

How do I take 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​1
  • NINLARO is taken in “cycles.” Each cycle lasts 4 weeks (28 days)​1
    • 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 dosage or stop NINLARO, REVLIMID, or dexamethasone if you have side effects​
  • Take NINLARO at least 1 hour before or at least 2 hours after food1
  • On the days that you take both NINLARO and dexamethasone, do not take NINLARO and dexamethasone at the same time. Take dexamethasone with food​1
  • Swallow NINLARO capsules whole with water. Do not crush, chew, or open the capsule​1
  • 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​1
  • 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​1
  • 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​1
  • Your healthcare provider may prescribe a medicine to take with NINLARO to decrease the risk of the chicken pox virus (herpes zoster) coming back (reactivation)​1
  • Taking too much NINLARO (overdose) can cause serious side effects, including death. If you take more NINLARO than instructed by your healthcare provider, call your healthcare provider right away or go to the nearest hospital emergency room right away. Take your medicine pack with you1
What do I do if I take a dose of NINLARO and vomit?

If vomiting occurs after taking a dose, you should not repeat the dose. Even after vomiting a dose, your body may have taken in some of the medication. Instead of repeating the dose, take your next dose of NINLARO on the next scheduled day and time.1

How is NINLARO administered differently from other proteasome inhibitors?

It is possible that you’ve taken other proteasome inhibitors in the past. NINLARO is different because it is the first and only proteasome inhibitor that you can take at home in capsule form.1

How does NINLARO work?

NINLARO targets a part of cells called proteasomes. It works by slowing down or blocking proteasomes from doing their job of digesting proteins. In myeloma cells, there is a greater need for proteasomes to digest proteins; the buildup of excess proteins causes cell death.1

What if I have more questions about NINLARO?

If you have questions, you should first contact your healthcare provider. Use the Conversation Starter to prepare questions about any topic that you would like to know more about. This guide can also help you get the most out of your discussion, with helpful tips to use when talking with your healthcare team.

Considerations and resources for patients starting the NINLARO regimen

Sharing the following information about NINLARO at the start of treatment can help ensure that patients and caregivers are well-informed:​

✓ Drug indication​ and usage

✓ Dose and dosing schedule​

✓ Start date

✓ Handling instructions​

✓ Administration and what to do if a dose is missed or too much NINLARO is taken​

✓ Food and drug interactions​

✓ Side effects and management

Providing these brochures to patients and caregivers can help communicate key information on NINLARO treatment and support.

NINLARO Treatment Guide

NINLARO® (ixazomib) Treatment Guide PDF.
A patient-friendly guide that provides information on the NINLARO regimen, how to take it, and other helpful tips.

Takeda Oncology Here2Assist® Brochure

Takeda Oncology Here2Assist® brochure PDF.
Information about access, financial assistance, and available support services.

Patient resources

Support and resources can be easily accessed on the NINLARO patient website.

Takeda Oncology Here2Assist®

We're here to help your patients with their coverage, financial, and educational resource needs.