TAKE THE NINLARO® (IXAZOMIB) COMBINATION WHEREVER YOU GO

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What is the NINLARO treatment combination* dosing schedule?

The all-oral NINLARO treatment combination gives time back to you as well as your loved ones and care partners. With no travel to the clinic required for dosing of the all-oral NINLARO treatment combination*, NINLARO is taken just once a week for 3 weeks each month—at home, on the go, or wherever life takes you. NINLARO is taken along with 2 other oral medications, REVLIMID® (lenalidomide) and dexamethasone, as part of a three-pill combination, in 4-week cycles.

*NINLARO + lenalidomide + dexamethasone.

The NINLARO treatment combination for a 28-day cycle

The NINLARO® (ixazomib) treatment combination 28-day dosing schedule.

Learn about taking NINLARO on the go

Watch this quick and helpful video to better understand how to take NINLARO at home or on the go.

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Tips for taking NINLARO at home or on the go. Please see NINLARO important safety information at the end of this video.

 

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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.

 

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

 

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NINLARO is available in three doses. Your healthcare provider will determine the right NINLARO dose for you. Contact your healthcare provider if you have any questions about dosing.

 

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Always keep the NINLARO package closed. This prevents the medication card from sliding out of the sleeve.

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Only open the package when you are ready to take your medication.

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Follow these simple steps when you are ready to take your medication. Make sure that the blister pack is pushed all the way into the sleeve to help with the release.

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Step 1. Press in on the package with your thumb and hold, to release the locking mechanism.

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Step 2. While pressing and holding the button with your thumb, pull out the blister pack using your free hand.

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To access the NINLARO capsule, gently press on the blue tab to puncture the foil and remove the capsule.

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Use the calendar reminder on the medication box to record when you have taken your NINLARO doses.

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Remember to read these important reminders for taking NINLARO which can be found on the underside of the flap of the medication box.

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Remember to also read the NINLARO package insert fully before taking your medication.

 

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NINLARO is taken in cycles. Each cycle lasts 4 weeks or 28 days.

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Take the NINLARO dose once per week for the first 3 weeks of a 4-week cycle. Take NINLARO on the same day each week at roughly the same time. Refer to the patient information in the package insert for more information on how to take NINLARO in combination with REVLIMID and dexamethasone.

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Missed a dose? If a dose is missed or you are delayed in taking a dose of NINLARO, you can take the missed dose as long as the next scheduled one is more than 3 days away. Do not take a missed dose of NINLARO if it is within 3 days or 72 hours of your next scheduled dose.

 

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Store your NINLARO medication at room temperature. Do not store your medication above 86 degrees Fahrenheit or 30 degrees Celsius, and do not freeze.

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Keep your NINLARO medication out of the reach of children, and ask your pharmacist or healthcare team how to dispose of any unused medication.

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Always store NINLARO medication in its original packaging, and do not put your NINLARO medication in a pill box.

 

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The NINLARO capsule should be taken by mouth on an empty stomach at least 1 hour before, or 2 hours after ingesting food.

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Swallow the capsule whole with water. And wash your hands with soap and water after you have taken your medication.

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Do not crush, chew, or open the capsule. Also remember not to remove the capsule from its original packaging until time of consumption. 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.

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NINLARO may cause serious side effects. For more information, see the important safety information for NINLARO at the end of this video. If you experience any side effects, make sure to report these to your healthcare provider straight away.

 

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Refer to the patient information in the package insert for more information on how to take NINLARO in combination with REVLIMID and dexamethasone. You can also speak to your healthcare provider for more information.

 

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NINLARO is a treatment that allows lifestyle flexibility.

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The NINLARO regimen offers the convenience and simplicity of an all-oral regimen and offers flexibility to fit in with everyday life.

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"It's just the freedom to be able to conduct your life more independently and on your own. If I want to go somewhere today, I can go there and I can take this oral pill with me if I hadn't taken it yet." A quote from Joe, a real patient taking the all-oral NINLARO regimen.

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With the NINLARO regimen you can take your treatment without disrupting your daily activities.

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At home, or on the go.

 

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

Important safety information for NINLARO (ixazomib). NINLARO may cause serious side effects, including: 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.

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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, or 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 face, 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, or 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).

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Other common side effects of NINLARO include low white blood cell counts (neutropenia) 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 or www.fda.gov/medwatch.

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Before taking NINLARO, tell your healthcare provider about all 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. 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 last 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. 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 you. Please see Patient Information in the NINLARO (ixazomib) full prescribing information.

How should I take NINLARO?

Staying on top of your dosing schedule is key. The information in this section is based on how NINLARO was approved by the FDA. Please make sure to take the NINLARO treatment combination as prescribed by your healthcare provider.

NINLARO is different than other proteasome inhibitors because it is the first and only proteasome inhibitor that you can take on-the-go in capsule form. NINLARO is taken orally, so you don’t need to travel to a clinic or worry about scheduling extra appointments for injections or infusions. You still need to have your regular visits with your doctor.

NINLARO comes in a package that is different from other packaging you may have opened in the past. Get helpful step-by-step instructions for opening your NINLARO package.

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Take each dose of NINLARO at about the same time of day each week.

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Take each dose of NINLARO at least 1 hour before or at least 2 hours after food.

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Swallow NINLARO capsules whole with water. Do not crush, chew, or open the capsule.

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Do not take NINLARO at the same time as dexamethasone.

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Take NINLARO exactly as your healthcare provider tells you to take it.

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Your healthcare provider will do blood tests during treatment with NINLARO to check for side effects.

What if I miss a dose?

If you miss a dose of NINLARO, you can take the missed dose as long as the next scheduled one is more than 3 days away. NINLARO is absorbed into your body very quickly.

If you vomit after taking a dose of NINLARO, do not repeat the dose. Instead, take your next dose of NINLARO on the next scheduled day and time.

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What are some tips for staying on treatment?

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Partner with your care team

Even with the best intentions, it’s possible to miss doses of your treatment. You may be balancing dosing schedules, be concerned about side effects, or just forget because you’re human. Staying on therapy is about partnership. You and your healthcare team should work together to make decisions about your care. The goal is for you to have an understanding of, and control in, your treatment plan.

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Make every dose everyone's responsibility

The good news is that your healthcare team, care partners, and loved ones can all help with adherence or taking all medications as prescribed by your healthcare provider. This way, the responsibility doesn't fall entirely on you. Talk with your care team about the importance of adherence and how you can work together to stay on treatment. When talking with your healthcare team specifically, consider the using the conversation starter to start thinking of questions to ask.

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Ask questions

Make sure that you fully understand your treatment and clarify anything that's confusing. Ask for information about potential side effects of treatment. Always talk to your doctor, as there are changes that can be made to your dose if you experience certain side effects.

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Remember to take your medication

Forgetting to take your medicine is a common reason for nonadherence. The important thing is that you are open with your care team and take steps to prevent it from happening.

How can I remember to take my medication?

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Build a routine and take your medication during a certain activity (eg, brushing your teeth, getting ready for the day)

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Keep track of doses you've taken by recording each one in a medication diary

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Set alarms (eg, watches, smartphones, text/call reminders)

What are some important things to remember when taking NINLARO?

  • For your safety, NINLARO has been sealed in a protective slipcase. You and your care team should keep NINLARO in this package until it's time to take your medication
     
  • 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
     
  • Store NINLARO capsules in the original packaging until just before each use
     
  • Store NINLARO at room temperature. Do not store above 30°C (86°F)
     
  • Do not freeze NINLARO
     
  • Keep NINLARO and all medicines out of the reach of children

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