Healthcare Professional & Patient Videos

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Indolent Relapse in Multiple Myeloma – Expert Discussion on a Patient-Centered Treatment Approach

[Voiceover]

INDICATIONS AND USAGE

Indication: NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

Please see full Important Safety Information at end of video. 

DR. PUCKETT: Hello, my name is Dr. Brian Puckett. Today I’ll be presenting a roundtable panel discussion on multiple myeloma patient care with two national experts: Dr. Saulius Girnius of Good Samaritan Hospital in Cincinnati, and Dr. Mihir Raval of the Albany Medical Center. We’ll be discussing treatment of patients experiencing an indolent first relapse, also known as a biochemical relapse. This type of relapse is asymptomatic in nature and is characterized by a slow rise of M proteins and no multiple myeloma-related organ dysfunction. We’ll hear clinical insights from Dr. Girnius and Dr. Raval on a hypothetical patient case, as well as one treatment approach they would consider.

DR. PUCKETT: Welcome Dr. Girnius and Dr. Raval. Thank you so much for joining us.

DR. RAVAL: Thank you for having us.

DR. GIRNIUS: I’m glad to be here.

DR. PUCKETT: Let’s get started.

DR. PUCKETT: First, let’s meet our hypothetical patient. Bruce is a 58-year-old male. While he sometimes works from home, he still works from the office regularly. He’s nearing retirement and is ready for what’s next.

DR. PUCKETT: Bruce presents for a follow-up clinic visit. He was diagnosed with multiple myeloma 3.5 years ago and achieved a VGPR on his first line of therapy, with 4 cycles of a PI combined with an immunomodulator and a steroid followed by autologous stem cell transplant. He then received immunomodulator therapy for 2 years at a suboptimal dosage. At his appointment, Bruce’s doctor performed the labs shown on screen. His M protein levels had slowly increased, confirming his relapse. Bruce did not present with clinical symptoms and he is not considered lenalidomide refractory.

Dr. Raval, do you treat patients with a similar profile to Bruce?

DR. RAVAL: In my clinical practice, I frequently see patients like Bruce, with rising M protein levels after initial PI-based treatment and transplant. In fact, about one-third of first relapses in multiple myeloma are indolent, so I continue to follow patients closely, even if they are not exhibiting symptoms of relapse. Outcomes can deteriorate as more lines of therapy are pursued, so it is critical that Bruce work with his provider to find an effective treatment.

DR. GIRNIUS: I agree with Dr. Raval. Some patients like Bruce, with a good ECOG performance status and lacking physical symptoms of aggressive or clinical relapse, may not have discovered this relapse as early.

Furthermore, the first relapse is a critical juncture in the multiple myeloma treatment journey. I tell patients that disease phases in multiple myeloma often resemble this chart, with M protein levels responding to a treatment before spiking again as they relapse on that treatment. I tell patients that relapsing on a treatment means it may be time for a new approach.

DR. PUCKETT: Those are great insights. Since Bruce is at an important point in his multiple myeloma journey, let’s examine his goals for treatment. He wants to keep doing the things that matter to him, and he wants a treatment option that could help delay his disease progression.

Dr. Raval, how do you guide the conversation at this point?

DR. RAVAL: Bruce wants to delay disease progression without ceding control over his schedule to a demanding dosing regimen. I see this frequently, especially in patients post-transplant, some of whom may just be getting back into a routine that includes social events, normal working hours, and flexibility in their calendar.

For appropriate patients like Bruce, I discuss the NINLARO (ixazomib) regimen, which also includes lenalidomide and dexamethasone, as one treatment option, because it offers a convenient, all-oral dosing regimen that can be taken at home, paired with a proven efficacy and safety profile.

DR. GIRNIUS: I agree with Dr. Raval.

TOURMALINE-MM1 was a global, Phase 3, randomized 1-to-1, double-blind, placebo-controlled study that evaluated the safety and efficacy of the NINLARO regimen vs the Rd regimen in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies. NINLARO demonstrated a significant delay in disease progression. In the trial, patients on the NINLARO regimen saw a median PFS of 20.6 months, compared to 14.7 months for patients on the Rd regimen.

DR. RAVAL: The NINLARO regimen also demonstrated a safety profile comparable to the Rd regimen.

In the clinical trial, the most frequently reported adverse reactions (≥20% with a difference of ≥5% compared to placebo) in the NINLARO regimen were thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis.

DR. GIRNIUS: NINLARO offers the convenience of weekly oral administration. The recommended starting dose of NINLARO is 4 milligrams, one capsule. It should be taken weekly for 3 of every 4 weeks on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO should be taken with lenalidomide and dexamethasone at standard dosing. Twenty-five milligrams of lenalidomide should be taken daily on days 1 through 21, and 40 milligrams of dexamethasone on days 1, 8, 15, and 22.

For a patient such as Bruce, who is experiencing an indolent first relapse in multiple myeloma, I would look for an option that may deliver extended efficacy, manageable tolerability, and convenient dosing. The NINLARO regimen is one such option.

DR. PUCKETT: Thank you both so much for sharing your clinical insights with us. It’s been wonderful having you together.

That concludes our expert roundtable discussion.  We hope you’ve learned something beneficial for your clinical practice.

[Voiceover]

INDICATIONS AND USAGE

Indication: NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO. Platelet nadirs typically occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. Grade 3 thrombocytopenia was reported in 17% of patients in the NINLARO regimen and Grade 4 thrombocytopenia was reported in 13% in the NINLARO regimen. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 3% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.

Peripheral Neuropathy was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (24% and 17% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (<1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 4% of patients in the NINLARO regimen and <1% of patients in the placebo regimen. During treatment, monitor patients for symptoms of neuropathy and consider adjusting dosing for new or worsening peripheral neuropathy.

Peripheral Edema was reported with NINLARO. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of NINLARO for Grade 3 or 4 symptoms or dexamethasone per its prescribing information.

Cutaneous Reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported with NINLARO. If Stevens-Johnson syndrome occurs, discontinue NINLARO and manage as clinically indicated. Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in <1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.

Thrombotic Microangiopathy has been reported with NINLARO. Fatal cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received NINLARO. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop NINLARO and evaluate. If the diagnosis of TTP/HUS is excluded, consider restarting NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TTP/HUS is not known.

Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in <1% of patients treated with NINLARO. Hepatotoxicity has been reported (10% in the NINLARO regimen and 9% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.

Embryo-fetal Toxicity: NINLARO can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with NINLARO and for 90 days following the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with NINLARO and for 90 days following the last dose.

Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting: In two prospective randomized clinical trials in multiple myeloma in the maintenance setting, treatment with NINLARO resulted in increased deaths. Treatment of patients with NINLARO for multiple myeloma in the maintenance setting is not recommended outside of controlled trials.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) in the NINLARO regimen compared to placebo in combination with lenalidomide plus dexamethasone, respectively were thrombocytopenia (85%, 67%; pooled from adverse event and laboratory data), neutropenia (74%, 70%; pooled from adverse event and laboratory data), diarrhea (52%, 43%), constipation (35%, 28%), peripheral neuropathy (32%, 24%), nausea (32%, 23%), edema peripheral (27%, 21%), rash (27%, 16%), vomiting (26%, 13%), and bronchitis (22%, 17%). Serious adverse reactions reported in ≥ 2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%).

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.
• Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.
• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see NINLARO (ixazomib) full Prescribing Information.

References

1. Data on File. Takeda Pharmaceuticals U.S.A., Inc.; 2022.
2. Durie BGM. Concise Review of the Disease and Treatment Options: Multiple Myeloma: Cancer of the Bone Marrow. 2011/2012 ed. Internal Myeloma Foundation; 2011.
3. Hemady. Prescribing Information Acrotech Biopharma LLC; 06/2021.
4. Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621-1634 [supplementary appendix].
5. NINLARO. Prescribing Information. Takeda Pharmaceuticals America, Inc.; 07/2024.
6. Revlimid. Prescribing Information. Celgene Corporation; 03/2023.

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Patient-Centered Approached in Multiple Myeloma: Expert Insights in Treating Patients at First Relapse.

[Voiceover]

INDICATIONS AND USAGE

Indication: NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

Please see full Important Safety Information at end of video. 

DR. PUCKETT: Hello, my name is Dr. Brian Puckett. Today we’ll be presenting a roundtable discussion between two national experts in treating patients with multiple myeloma at first relapse. Dr. Saulius Girnius from Good Samaritan Hospital in Cincinnati, and Dr. Mihir Raval of the Albany Medical Center will share their clinical insights on the case of Alice, a hypothetical elderly patient with multiple myeloma who has an active lifestyle. We’ll discuss her case in detail, as well as one treatment option physicians may consider when treating patients like Alice. 

DR. PUCKETT: Welcome Dr. Girnius and Dr. Raval. Thank you so much for joining us.

DR. RAVAL: Thank you for having us.

DR. GIRNIUS: I’m glad to be here.

DR. PUCKETT: Let’s get started. 

DR. PUCKETT: Alice is a 75-year-old female with an active lifestyle who is experiencing her first relapse in multiple myeloma. She would like to keep doing the things she enjoys, like gardening and spending time with her grandchildren. 

DR. PUCKETT: Alice presents to her physician with new-onset back pain and generalized fatigue. She was diagnosed with multiple myeloma 2 years ago and has a history of hypertension.

Alice was initially treated with an injectable PI plus immunomodulator plus steroid regimen for 9 months and achieved a best response of VGPR. She continued treatment with an immunomodulator as maintenance therapy in a suboptimal dosage. Alice is not lenalidomide refractory. Standard laboratory tests were performed. Dr. Raval, what are your thoughts on Alice’s case so far? 

DR. RAVAL: Alice’s labs are within a reasonable range, and her performance status is good for her age. I am encouraged to see she achieved a VGPR on her previous line of therapy, and her lack of cytogenetic risk factors and current R-ISS staging mean there are many treatment options available to her. Dr. Girnius, I’m curious how you would approach a treatment journey at this stage? 

DR. GIRNIUS: As a provider, it is important for me to discuss my patient’s individual treatment journey and goals at every stage of treatment. Especially with the advent of instant patient access to lab results, patients are often highly informed about their progress on therapy and come to each appointment with not only their own questions and priorities, but also anxieties. I will often explain that relapse after first-line therapy is an expected part of the disease course.

DR. PUCKETT: Let’s take a look at Alice’s goals for treatment. One of her priorities is maintaining her independence with a therapy that may allow her to live longer without her disease getting worse and without compromising her lifestyle. An option with convenient dosing and manageable tolerability is also important to her. 

Dr. Raval, when a patient like Alice experiences a first relapse and visits you, how do you guide the conversation knowing these are her priorities? 

DR. RAVAL: In my clinical experience, these patients may already be dealing with a high burden of disease and barriers to independent living. They don’t want their treatment to further complicate their lives. When choosing our next line of therapy, I explain that different treatment options have different dosing and safety profiles that we can consider alongside proven efficacy. 

DR. GIRNIUS: I agree with Dr. Raval. When discussing post-relapse treatment options with patients, I ensure we discuss any lifestyle and logistical considerations that may make frequent office visits more taxing. For patients who want to maintain an active lifestyle, I explain that the all-oral NINLARO (ixazomib) regimen is an appropriate treatment option to consider. 

DR. RAVAL: TOURMALINE-MM1 was a global, Phase 3, randomized 1-to-1, double-blind, placebo-controlled study that evaluated the safety and efficacy of the NINLARO regimen vs the Rd regimen in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies. NINLARO demonstrated a significant delay in disease progression. In the trial, patients on the NINLARO regimen saw a median PFS of 20.6 months, compared to 14.7 months for patients on the Rd regimen. 

DR. RAVAL: The NINLARO regimen demonstrated a safety profile comparable to the Rd regimen. 
In the clinical trial, the most frequently reported adverse reactions (≥20% with a difference of ≥5% compared to placebo) in the NINLARO regimen were thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis. 

DR. GIRNIUS: NINLARO offers the convenience of weekly oral administration. The recommended starting dose of NINLARO is 4 milligrams, one capsule. It should be taken weekly for 3 of every 4 weeks on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO should be taken with lenalidomide and dexamethasone at standard dosing. Twenty-five milligrams of lenalidomide should be taken daily on days 1 through 21, and 40 milligrams of dexamethasone on days 1, 8, 15, and 22. 

For elderly patients with an active lifestyle like Alice, who are looking for extended efficacy and manageable tolerability, as well as convenient all-oral dosing, I discuss the NINLARO regimen as an appropriate treatment option for elderly patients with relapsed multiple myeloma. 

DR. PUCKETT: Thank you both for sharing your insights in treating active elderly patients with multiple myeloma at first relapse. 

DR. GIRNIUS: My pleasure. 

DR. RAVAL: Thank you for having us. 

DR. PUCKETT: Please stay tuned for the complete Important Safety Information for NINLARO. 
 

[Voiceover]

INDICATIONS AND USAGE

Indication: NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO. Platelet nadirs typically occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. Grade 3 thrombocytopenia was reported in 17% of patients in the NINLARO regimen and Grade 4 thrombocytopenia was reported in 13% in the NINLARO regimen. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 3% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.

Peripheral Neuropathy was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (24% and 17% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (<1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 4% of patients in the NINLARO regimen and <1% of patients in the placebo regimen. During treatment, monitor patients for symptoms of neuropathy and consider adjusting dosing for new or worsening peripheral neuropathy.

Peripheral Edema was reported with NINLARO. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of NINLARO for Grade 3 or 4 symptoms or dexamethasone per its prescribing information.

Cutaneous Reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported with NINLARO. If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs, discontinue NINLARO and manage as clinically indicated. Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in <1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.

Thrombotic Microangiopathy has been reported with NINLARO. Fatal cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received NINLARO. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop NINLARO and evaluate. If the diagnosis of TTP/HUS is excluded, consider restarting NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TTP/HUS is not known.

Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in <1% of patients treated with NINLARO. Hepatotoxicity has been reported (10% in the NINLARO regimen and 9% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.

Embryo-fetal Toxicity: NINLARO can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with NINLARO and for 90 days following the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with NINLARO and for 90 days following the last dose.

Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting: In two prospective randomized clinical trials in multiple myeloma in the maintenance setting, treatment with NINLARO resulted in increased deaths. Treatment of patients with NINLARO for multiple myeloma in the maintenance setting is not recommended outside of controlled trials.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) in the NINLARO regimen compared to placebo in combination with lenalidomide plus dexamethasone, respectively were thrombocytopenia (85%, 67%; pooled from adverse event and laboratory data), neutropenia (74%, 70%; pooled from adverse event and laboratory data), diarrhea (52%, 43%), constipation (35%, 28%), peripheral neuropathy (32%, 24%), nausea (32%, 23%), edema peripheral (27%, 21%), rash (27%, 16%), vomiting (26%, 13%), and bronchitis (22%, 17%). Serious adverse reactions reported in ≥ 2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%).

DRUG INTERACTIONS:

Avoid concomitant administration of NINLARO with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment with NINLARO and for 90 days after the last dose. 

Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. 

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see NINLARO (ixazomib) full Prescribing Information.

[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 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 area (abdomen).

Other common side effects of NINLARO include low white blood cell counts and bronchitis (neutropenia).

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.

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