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ABOUT MULTIPLE MYELOMA RELAPSES

ABOUT NINLARO

PATIENT RESOURCES

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Get information on:

TIPS FOR LIVING WELL

WHY MM COMES BACK

WHAT TO EXPECT WITH MM

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Get information on:

TAKING NINLARO

RESULTS WITH NINLARO

SIDE EFFECTS WITH NINLARO

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Get information on:

THE NINLARO TREATMENT COMBINATION

Caregiver Resources

[H2]
Joe's Multiple Myeloma Journey

"NINLARO gave the me the ability to say, 'Hey I can still work. I can still travel.' I don't have to be home and in the hospital on these days of the week. I can take my treatment with me and be able to work and have more of a full life from that possibility."

Joe, real patient taking NINLARO

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[Text on screen]

This video features a real patient sharing his experience living with multiple myeloma and being treated with NINLARO®. The information in this video is based on his experience at the time of recording. Given the nature of multiple myeloma, experiences may change over time. This is Joe’s experience while taking NINLARO, and yours may be different.

[No voiceover]

JOE:  I've been married for 48 years. We normally are early risers, so we get up anywhere from 5:30 to 6:30 in the morning.

We like to exercise as a way to keep ourselves active and keep our bodies active, and I feel it's important with my multiple myeloma to make sure that I keep myself in shape and maintain a good health.

JOE:  My name is Joe, I'm 69 years old and I'm living with multiple myeloma.

Before I was diagnosed with multiple myeloma, I had really no serious illnesses or complaints or problems at all.

[No voiceover]

JOE: That's when he told us that I had, sorry, multiple myeloma and that was a shock. He brought in the whole team. He explained everything. He told me that I had two lesions on each of my femurs with the 30% bone loss and that it was something that I needed to take a look at now, not something that I could wait a year on. He said he would suggest that I go ahead and got into the protocol for a stem cell transplant and we kind of left the office that day in shock.

[No voiceover]

JOE:  It was after the 100-day mark of getting the post stem cell transplant analysis, that it was kind of another shock as they came up and said that the results indicated I did not go into remission. It was a partial response. The numbers were low but not into, not zero. But then around the four-month mark, the numbers started to go up.

[No voiceover]

JOE:  My numbers steadily kept going up and we were talking with the care team about what's the next step  and what kind of treatments were out there. They talked about this drug NINLARO.

VO:  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're 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.

VO: Please see Important Safety Information for NINLARO at the end of this video.

[No voiceover]

JOE:  I've been on NINLARO now five years. And I got to say I'm extremely happy with the results so far. In my experience taking NINLARO, the side effects have really been very minimal.

VO: The most common side effects of NINLARO include low platelet counts, low white blood cell counts, diarrhea, constipation, nerve problems, nausea, swelling, rash, vomiting, and bronchitis.

JOE:  I mean, to me it's just the freedom to be able to conduct your life more independently and on your own. To be able to say, "You know, 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." Versus, "Oh, I need to plan around the fact that I've got to be at the hospital tomorrow to get an infusion."

JOE: It was like the best of both worlds.

NINLARO gave me the ability to say, "Hey, I can still work. I can still travel. I don't have to be home and in the hospital on these days of the week and then try to get out on the road on the rest of the week. I can take my treatment with me and be able to work and have more of a full life from that possibility."

JOE: We have a bucket list for my wife and I. We're looking at going to different hockey games where the Pittsburgh Penguins play and seeing every stadium they play in. And at the same time mix that in with seeing the grandsons and watching them grow up and playing their sports and doing their things. So there’s some big plans we have.

JOE:  With taking an oral medication versus an infusion, the ability to have freedom to conduct my life and lifestyle in a more normal manner.

Life with multiple myeloma has taught me that you need to value your experience and your life as it is and concentrate on those things that are important to you and your family.

VO: 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.
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 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.

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 or www.fda.gov/medwatch.

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.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements or before starting any new medicines. Talk to your healthcare provider before starting any new medicines during treatment with NINLARO.

Please visit NINLARO.com for full Prescribing Information including Patient Information.

[H2]
How can NINLARO help?

NINLARO is the first and only oral medication of its kind, a proteasome inhibitor, that may help people when their multiple myeloma comes back. In a study of multiple myeloma patients whose disease had returned after a prior treatment, the combination of NINLARO plus REVLIMID® (lenalidomide) and dexamethasone was shown to improve the time people were able to live with their multiple myeloma without it getting worse by nearly 6 months (20.6 months for the people who took the NINLARO treatment combination† vs 14.7 months for those who took the lenalidomide + dexamethasone combination†).

†The NINLARO treatment combination included NINLARO + lenalidomide + dexamethasone; the lenalidomide + dexamethasone combination included placebo + lenalidomide + dexamethasone.

DISCOVER STUDY RESULTS

[IMG: Woman working out with hand weights. Man and woman smiling while looking off camera.]

[H2] IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE
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[H3] 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.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).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.
[H3] 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 tr

[H2]
Overview of the NINLARO study*

The treatment combination of NINLARO + lenalidomide + dexamethasone was tested in a clinical study compared to placebo + lenalidomide + dexamethasone in people whose multiple myeloma had returned. This study evaluated the efficacy and safety profile of NINLARO in combination with lenalidomide + dexamethasone.

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The study compared a three medication vs a two medication combination†

[IMG: The NINLARO® (ixazomib) combination consisting of NINLARO, lenalidomide, and dexamethasone vs a placebo, lenalidomide, and dexamethasone combination]

*The US Food and Drug Administration (FDA) approved NINLARO based on the results of this clinical study. This study tested the NINLARO treatment combination (NINLARO + lenalidomide + dexamethasone) compared with placebo + lenalidomide + dexamethasone in 722 people whose multiple myeloma had come back or stopped responding to prior therapy. It measured the length of time a patient lived without their disease getting worse.†Placebo pills are not active.

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When multiple myeloma returns, taking the NINLARO treatment combination may help you live longer without your multiple myeloma getting worse

The NINLARO treatment combination (NINLARO + lenalidomide + dexamethasone) was proven to be an effective treatment for people whose multiple myeloma had come back or stopped responding to prior therapy.

[H4]
Progression-free survival (PFS)

In the clinical study, people taking the NINLARO treatment combination went more than a year and a half (20.6 months) without their multiple myeloma getting worse compared to 14.7 months for people who took the lenalidomide + dexamethasone combination alone.

[H3]
The NINLARO treatment combination improved thetime people lived without their disease getting worse

[IMG: The NINLARO® (ixazomib) combination had a 6-month improvement in PFS in comparison to the lenalidomide + dexamethasone combination.]

‡NINLARO combination=NINLARO + lenalidomide + dexamethasone; lenalidomide + dexamethasone combination=placebo + lenalidomide + dexamethasone.

[H4]
Overall survival

In this study, people taking the NINLARO treatment combination lived a similar overall length of time after diagnosis as people who received the lenalidomide+dexamethasone combination alone.

[H2]
The NINLARO treatment combination was proven to work quickly and effectively

[IMG: Ten people icons with 8 out of the 10 filled in.]

Most people had a response.

78% of people responded to the NINLARO treatment combination (vs 72% with the lenalidomide + dexamethasone combination). Of those people, 48% had a very good partial response (VGPR)§ or a complete response (CR)‖‖

[IMG: 1.1 months.]

Fast responses.

The NINLARO treatment combination was proven to work fast. Of the people who responded to it, half of them saw their first response in less than 1.1 months (the other half taking the NINLARO treatment combination took longer to see a response) compared with about 2 months for the lenalidomide + dexamethasone combination.

[IMG: Down arrow icon above M protein.]

Deepened responses over time.

Response to the NINLARO treatment combination deepened with more time on treatment. For example, twice as many people saw a complete response|| to treatment (disappearance of the M protein) after 12 months compared to after 6 months. Responses improved over time for both treatment combinations in the study.

§A 90% or greater decrease in M protein (an abnormal myeloma protein produced by myeloma cells). Also called very good partial remission.
‖‖Complete response is when there are less than 5% plasma cells in the bone marrow and blood and urine lab tests show no M protein.

[H2] IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE
Expand+

[H3] 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.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).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.
[H3] 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 accompanying NINLARO (ixazomib) full Prescribing Information.

[H3] 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.

[H2]
As the only oral proteasome inhibitor used to treat relapsed multiple myeloma NINLARO is different

NINLARO blocks the action of proteasomes, which break down unneeded proteins inside cells. By blocking proteasomes inside myeloma cells, NINLARO creates a buildup of proteins, causing the myeloma cells to die.Proteasome inhibitors are a proven foundation for myeloma treatment. NINLARO is the first and only proteasome inhibitor that is taken orally. NINLARO is taken as part of an all-oral treatment combination*. NINLARO is not chemotherapy and does not require injections or infusions.

*NINLARO + lenalidomide + dexamethasone.

[H2]
How NINLARO works inside myeloma cells

Learn how NINLARO specificallytargets proteasomes to helpdestroy myeloma cells.

ViewHide Transcript

Multiple myeloma is a cancer of the bone marrow. Takeda has been engaged in the fight against multiple myeloma for nearly two decades.The disease is characterized by the abnormal growth of cells called plasma cells [1] [2].Inside the cell, the proteasome is something that helps get rid of a build-up of proteins [3].Myeloma cells rely on the proteasome to survive [3].Text appears on screen: Proteasome Inhibitors (PIs) stop cell growth and cause cell death.By targeting the proteasome, these therapies may be able to stop cell growth, and cause cell death.Text appears on screen: These therapies target the proteasome to treat multiple myeloma.Treatments that target the proteasome are called proteasome inhibitors. They are a cornerstone of multiple myeloma treatment [3].NINLARO® or ixazomib is a type of proteasome inhibitor [4]. 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 [4].Text appears on screen: NINLARO® (ixazomib) may affect healthy cells.As a proteasome inhibitor, NINLARO directly binds to the proteasome……helping to reduce its activity [4].By stopping the proteasome, proteins begin to build up inside myeloma cells……and the build-up can cause death of the cancer cells [3].Text appears on screen: NINLARO® (ixazomib) may affect healthy cells.NINLARO is the first and only all-oral proteasome inhibitor [1].NINLARO may be an alternative to other treatments for people whose multiple myeloma has come back for the first time [4].If you have had at least one prior treatment for your multiple myeloma, your doctor may consider if the NINLARO regimen is right for you after your multiple myeloma first comes back [4].Text appears on screen: Those that have had at least one prior treatment when multiple myeloma comes back for the first time.The NINLARO regimen may be a good treatment option for you when your multiple myeloma comes back as a slow progressive disease with limited symptoms or you are a patient with an active lifestyle [1] [4].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.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 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).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 or www.fda.gov/medwatch.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 [4].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 full Prescribing Information.NINLARO is the first and only oral medication of its kind. A proteasome inhibitor that goes where you go.Have questions about NINLARO? Speak with your doctor to find out more.REFERENCES:Raedler LA. Ninlaro (ixazomib): first oral protease inhibitor. Approved for the treatment of patients with relapsed or refractory multiple myeloma. Am Health Drug Benefits. 2016;9(Spec Feature):102-105.Mahindra A, Hideshima T, Anderson KC. Multiple myeloma: biology of the disease. Blood Rev. 2010;24 Suppl 1:S5-S11.Moreau P, Richardson PG, Cavo M, Orlowski RZ, San Miguel JF, Palumbo A, Harousseau JL; Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012;120(5):947-959.NINLARO. Prescribing Information. Takeda Pharmaceuticals America, Inc.; 07/2024.

[H2]
Understanding NINLARO

[IMG: Key showing a multiple myeloma cell, protein, NINLARO, proteasome, and a digested protein.]

[IMG: Illustration of a myeloma cell.]

[H4]
Myeloma Cell

Proteasomes act like a garbage disposal system, helping to clean up damaged or unneeded proteins inside cells

In myeloma cells, there is a greater need for proteasomes to remove excess proteins that aren’t useful to the cell

[IMG: Illustration of NINLARO® (ixazomib) entering the cell and binding to proteasomes.]

[H4]
Proteasome inhibition with NINLARO

NINLARO is a small molecule that enters the myeloma cell and binds proteasomes​

When it binds the proteasomes inside cells, it slows down or blocks proteasomes from doing their job of discarding damaged proteins within cells

[IMG: Illustration of the death of a myeloma cell.]

[H4]
Proteasome inhibition effects

Blocking proteasomes with NINLARO causes a buildup of proteins in the cell

This leads to the death of myeloma cells

[H3] Results with NINLARO
Explore study data for NINLARO in combinationwith lenalidomide + dexamethasone.

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[H3] How to take NINLARO
Learn about taking the all oralNINLARO treatment combination.

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[H2]
What is a relapse in multiple myeloma?

Although treatment can reduce the number of myeloma cells in the body, there may be cells that remain or become resistant to treatment. Over time, these cells may start to multiply. After a period of improvement following treatment, multiple myeloma will return for most people, which is known as a relapse. A relapse may mean that you and your healthcare provider should consider a new treatment.

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[H4]
How often can multiple myeloma relapse?

Almost all people with multiple myeloma will experience a relapse and some may experience several relapses over time. If you have multiple myeloma, it is likely it will come back, even after successful treatment. When multiple myeloma relapses, lab tests will show increasing levels of an abnormal antibody called M protein.

[IMG: Graph outlining a multiple myeloma journey.]

[H2]
A multiple myeloma relapse can occur with or without symptoms

When multiple myeloma returns, the experience can be different for every person. Some people have symptoms when multiple myeloma relapses, while others may not. Some people only learn that a treatment change may be needed because of certain changes in lab results, such as increasing levels of M protein. When multiple myeloma relapses, you may hear different terms used to describe the relapse: Progressive disease: Multiple myeloma that has progressed as measured by serum or urine laboratory tests or by imaging studies.  Refractory disease: When multiple myeloma doesn’t initially respond or stops responding to a certain treatment, it is known as refractory multiple myeloma. This is also known as treatment resistance.  Primary refractory disease: Multiple myeloma that does not respond to initial treatment.

Talk to your healthcare provider about your M proteins levels and how you're feeling—be sure to communicate any changes, even small ones. Symptoms can be subtle at first and it can be hard to know if symptoms are related to your multiple myeloma relapsing or another condition.

[H2]
What are the signs that my multiple myeloma has relapsed?

Flip the cards over to learn about the types of multiple myeloma relapses.

LIMITED OR NO SYMPTOMS AND INCREASING M PROTEIN LEVELS(Also called an M spike)

This type of relapse is called an indolent relapse or biochemical relapse

Flip card

INDOLENT RELAPSES HAVE LIMITED OR NO SYMPTOMSNo obvious multiple myeloma symptoms (mild symptoms may not be noticeable)No organ problemsM spike identified on lab tests

SYMPTOMS AND INCREASING M PROTEIN LEVELS(Also called an M spike)

This type of relapse is known as a symptomatic relapse or clinical relapse

Flip card

SYMPTOMATIC RELAPSES HAVE OBVIOUS SYMPTOMSMultiple myelom a symptoms such as fatigue, shortness of breath, or bone painSymptoms may range from mild to severe and may change over timeOrgan problems may occur (such as kidney problems)

[H2]
Tracking M protein is a way of monitoring your multiple myeloma

[H4]
Lab tests can help monitor your multiple myeloma and signal the first sign of a relapse

An increase of M protein in your blood is a sign that your multiple myeloma may have relapsed. The amount of M protein is measured using a multiple myeloma test, the M spike lab test. It is called an M spike when M protein is detected in your blood or urine. Some people have myeloma cells that produce very little M protein, whereas others produce a lot of M protein, so it’s important to track your M protein levels individually over time.

[H3] Results with NINLARO
Explore study data for NINLARO in combination with lenalidomide + dexamethasone.

STUDY RESULTS

[H3] Lab test tracker
Details on common multiple myeloma tests and a place to record your values.

Track Lab Results

[H3] Side effects with NINLARO
Get details about potential side effects.

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[H2] IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE
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[H3] 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.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).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.
[H3] 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 accompanying NINLARO (ixazomib) full Prescribing Information.

[H3] 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.