Ninlaro (ixazomib)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Ixazomib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ixazomib
- Brand name
- Ninlaro
- Development code
- MLN9708
- Drug class
- Proteasome inhibitor
- Manufacturer
- Takeda (Millennium Pharmaceuticals)
- How it's taken
- Capsule taken by mouth once a week for 3 weeks of each 4-week cycle
Ninlaro (ixazomib) is a once-weekly proteasome inhibitor capsule, taken with lenalidomide and dexamethasone, for multiple myeloma after at least 1 prior therapy[1].
- The FDA approved Ninlaro on November 20, 2015, and the indication has not changed since, according to the label revised in August 2026[3][1].
- In a trial of 722 people with relapsed myeloma, adding Ninlaro to lenalidomide and dexamethasone lengthened median progression-free survival from 14.7 to 20.6 months[1][7].
- Ninlaro has no boxed warning, and its main safety concerns are low platelets, diarrhea and other stomach problems, nerve damage, swelling and rash[1].
- Since April 2022, the label has said Ninlaro is not recommended for maintenance treatment or newly diagnosed myeloma outside clinical trials, after 2 maintenance trials found more deaths[1][4].
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Where Ixazomib fits
Ninlaro is approved only in combination with lenalidomide and dexamethasone, for multiple myeloma in people who have received at least 1 prior therapy[1]. The label does not recommend it for maintenance treatment or for newly diagnosed myeloma outside controlled clinical trials[1]. Its main trial excluded people whose myeloma had stopped responding to lenalidomide or to a proteasome inhibitor[1].
How Ixazomib works
Cells rely on a large protein complex called the proteasome to break down proteins they no longer need[1]. Ixazomib attaches to the 20S core of the proteasome and reversibly blocks its main cutting function, called the chymotrypsin-like activity of the beta 5 subunit[1].
In laboratory studies, ixazomib caused myeloma cells to die (apoptosis), including cells taken from people whose myeloma had relapsed after bortezomib, lenalidomide and dexamethasone[1]. Ixazomib combined with lenalidomide killed more myeloma cells in the lab than either drug would be expected to alone[1].
Ninlaro is approved only as part of a 3-drug combination with lenalidomide (Revlimid), an immunomodulatory drug, and dexamethasone, a steroid[1].
Side effects and safety
- Thrombocytopenia. Low platelets in 85% on the Ninlaro combination (severe in 30%), lowest between Days 14 and 21 of each cycle; counts are checked at least monthly.
- Gastrointestinal toxicities. Diarrhea in 52%, constipation in 35%, nausea in 32% and vomiting in 26%, sometimes needing medicine or a dose change.
- Peripheral neuropathy. Nerve damage in 32% versus 24% on placebo, mostly grade 1 or 2; the dose is paused or lowered if it worsens.
- Peripheral edema. Swelling in 27% versus 21% on placebo; the care team looks for other causes and may adjust dexamethasone or Ninlaro.
- Cutaneous reactions. Rash in 27%; Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported.
- Thrombotic microangiopathy. TTP/HUS, a rare and sometimes fatal clotting disorder; Ninlaro is stopped if it is suspected.
- Hepatotoxicity. Drug-induced liver injury and hepatitis reported in under 1% each; liver enzymes are checked regularly.
- Embryo-fetal toxicity. Can harm an unborn baby; non-hormonal birth control for women and birth control for men for 90 days after the last dose.
- Increased mortality in the maintenance setting. 2 randomized maintenance trials found more deaths with Ninlaro; maintenance use is not recommended outside controlled trials.
- Platelet count at least monthly, more often in the first 3 cycles
- Neutrophil and platelet counts before each new cycle
- Symptoms of numbness, tingling, burning or weakness in the hands and feet
- Diarrhea, vomiting and fluid loss
- Swelling and weight gain from fluid
- New or worsening rash, blistering or mouth sores
- Liver enzymes regularly
- Signs of TTP/HUS such as fever, bruising or less urine
- Pregnancy status before starting
Ninlaro does not carry a boxed warning[1]. The safety numbers below come from the main trial, where 361 people took Ninlaro with lenalidomide and dexamethasone and 359 took placebo with the same 2 drugs[1].
Low platelets are the most common problem. Platelet counts fell in 85% of people on the Ninlaro combination (severe in 30%) versus 67% on placebo (severe in 14%), usually dipping between Days 14 and 21 of each cycle[1].
Other warnings on the label:
- Diarrhea in 52% versus 43%, constipation in 35% versus 28%, nausea in 32% versus 23% and vomiting in 26% versus 13%[1]
- Peripheral neuropathy (numbness, tingling or burning in the hands and feet) in 32% versus 24%, mostly mild[1]
- Swelling of the legs, arms or face (peripheral edema) in 27% versus 21%[1]
- Rash in 27% versus 16%; Stevens-Johnson syndrome and toxic epidermal necrolysis, severe blistering skin reactions, have been reported, including fatal cases[1]
- Thrombotic microangiopathy, a rare and sometimes fatal clotting disorder that can damage the kidneys[1]
- Liver injury, reported in under 1% for each specific type[1]
- More deaths when Ninlaro was used as maintenance treatment in 2 trials, which is why the label does not recommend that use outside trials[1]
Shingles (herpes zoster) occurred in 6% on Ninlaro versus 3% on placebo, and in only 1% of Ninlaro patients who took antiviral prevention compared with 10% who did not[1]. Eye problems such as cataract, pink eye, blurred vision and dry eye were reported in 38% of people on the Ninlaro combination[1]. About 10% of people stopped Ninlaro permanently because of a side effect[1].
Ninlaro can harm an unborn baby. The label calls for a pregnancy check before starting, non-hormonal birth control for women and birth control for men with partners who could become pregnant, each for 90 days after the last dose, and no breastfeeding for 90 days[1]. Dexamethasone may make hormonal birth control less effective[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ixazomib
Ninlaro is a capsule taken by mouth once a week on Days 1, 8 and 15 of a 28-day cycle, on the same day and at about the same time each week[1]. The usual starting dose is 4mg, with lenalidomide 25mg on Days 1 to 21 and dexamethasone 40mg on Days 1, 8, 15 and 22[1].
How the label says to take it:
- On an empty stomach, at least 1 hour before or at least 2 hours after food[1]
- Swallowed whole with water, never crushed, chewed or opened[1]
- A missed or late dose is taken only if the next dose is at least 72 hours away, and a dose is never doubled[1]
- A dose that is vomited is not repeated; the next dose is taken on schedule[1]
The label warns that taking more than prescribed has led to deaths, so the schedule matters[1]. Capsules come in 4mg, 3mg and 2.3mg strengths, and the dose steps down from 4mg to 3mg to 2.3mg for side effects[1]. People with moderate or severe liver impairment, severe kidney impairment or kidney failure on dialysis start at 3mg, and Ninlaro can be taken without regard to dialysis timing[1].
Before each new cycle, neutrophils should be at least 1,000/mm3 and platelets at least 75,000/mm3[1]. The label suggests antiviral medicine to lower the risk of shingles and says to avoid strong CYP3A inducers such as rifampin, phenytoin, carbamazepine and St. John's wort[1]. Ninlaro has no REMS program[1].
Availability and cost
Only available as the brand-name product.
Help paying for Ninlaro
With private insurance, the drugmaker's copay card can lower what you pay for Ninlaro. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Through the Takeda Oncology Co-Pay Assistance Program, people with commercial insurance may pay as little as $0 per prescription. No income requirements or membership fees. Not valid when Medicare, Medicaid, DoD, VA, TRICARE or a state pharmaceutical assistance program can pay any part of the claim. Re-enroll every 12 months.
For: private insurance · source - Insurance and case manager help
Takeda Oncology Here2Assist works with your insurance company to get you started, identifies financial assistance that may fit you, finds a specialty pharmacy and follows up during treatment. Call 1-844-817-6468, Option 2, Monday through Friday, 8 AM to 8 PM ET.
The official page does not say who qualifies. Ask the program. · source
Good to know: Takeda says Here2Assist can look for help whether or not you have insurance, but its Ninlaro page does not describe a free-drug program, so ask Here2Assist directly if you have Medicare or no insurance. Lost co-pay cards can be replaced through the same number, Option 2.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
The pivotal trial (NCT01564537), published as TOURMALINE-MM1, randomized 722 people whose myeloma had relapsed or stopped responding after 1 to 3 prior therapies to Ninlaro or placebo, each with lenalidomide and dexamethasone[1][8][7]. People whose myeloma was refractory to lenalidomide or a proteasome inhibitor were excluded[1].
Results from the label:
- Median progression-free survival: 20.6 versus 14.7 months, hazard ratio 0.74[1]
- Overall response: 78% versus 72%, with complete response in 12% versus 7%[1]
- Later analysis at a median follow-up of 23 months: median progression-free survival 20 versus 15.9 months, hazard ratio 0.82[1]
- Final overall survival at about 85 months of follow-up: 53.6 versus 51.6 months, hazard ratio 0.94[1]
The label's limits come from 3 other randomized trials. In 2 maintenance trials in newly diagnosed myeloma, C16019 (NCT02181413) after a stem cell transplant and C16021 (NCT02312258) without one, deaths were 27% versus 26% and 30% versus 27% with Ninlaro versus placebo[1][9][10]. In C16014 (NCT01850524), adding Ninlaro to lenalidomide and dexamethasone for newly diagnosed myeloma did not meet its progression-free survival goal[1][11].
Development history
Ixazomib, studied under the code MLN9708, was developed by Millennium Pharmaceuticals, now part of Takeda[3][9].
Myeloma milestones from FDA records:
- November 20, 2015: approval with lenalidomide and dexamethasone after at least 1 prior therapy[3]
- April 28, 2022: label update adding final overall survival results, a limitation of use against maintenance and newly diagnosed use outside trials, and a warning about more deaths in maintenance trials[4][2]
- March 1, 2024: toxic epidermal necrolysis added to the skin reaction warning[5]
- July 1, 2024: angioedema (sudden deep swelling) added to post-approval side effects[6]
Trial Friend checked FDA and Takeda sources for changes from 2024 to 2026. The indication is the same as in 2015, Drugs@FDA lists no new indication, and Takeda's US Ninlaro site, dated August 2026, still offers the medicine and its support program[2][14]. DailyMed shows a label revision in August 2026 with the same indication and warnings; Trial Friend could not find an FDA letter explaining that revision[1]. Drugs@FDA lists no generic ixazomib[2].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Ninlaro is 1 of 3 proteasome inhibitors on the US market and the only one taken by mouth; Velcade (bortezomib) is given by shot or vein and Kyprolis (carfilzomib) by vein[1][12][13]. No head-to-head trial on the Ninlaro label compares it with another proteasome inhibitor[1]. Proteasome inhibitors are usually paired with drugs from other classes, and Ninlaro's label pairs it with the immunomodulatory drug lenalidomide and the steroid dexamethasone[1].
Anti-CD38 antibodies, CAR-T cell therapies and bispecific antibodies are separate classes whose own labels set when they can be used.
Common questions about Ixazomib
▸What is Ixazomib (Ninlaro)?
Ninlaro (ixazomib) is a once-weekly proteasome inhibitor capsule, taken with lenalidomide and dexamethasone, for multiple myeloma after at least 1 prior therapy[1]. The FDA approved Ninlaro on November 20, 2015, and the indication has not changed since, according to the label revised in August 2026[3][1]. In a trial of 722 people with relapsed myeloma, adding Ninlaro to lenalidomide and dexamethasone lengthened median progression-free survival from 14.7 to 20.6 months[1][7]. Ninlaro has no boxed warning, and its main safety concerns are low platelets, diarrhea and other stomach problems, nerve damage, swelling and rash[1]. Since April 2022, the label has said Ninlaro is not recommended for maintenance treatment or newly diagnosed myeloma outside clinical trials, after 2 maintenance trials found more deaths[1][4].
▸How does Ixazomib work?
Cells rely on a large protein complex called the proteasome to break down proteins they no longer need[1]. Ixazomib attaches to the 20S core of the proteasome and reversibly blocks its main cutting function, called the chymotrypsin-like activity of the beta 5 subunit[1].
In laboratory studies, ixazomib caused myeloma cells to die (apoptosis), including cells taken from people whose myeloma had relapsed after bortezomib, lenalidomide and dexamethasone[1]. Ixazomib combined with lenalidomide killed more myeloma cells in the lab than either drug would be expected to alone[1].
Ninlaro is approved only as part of a 3-drug combination with lenalidomide (Revlimid), an immunomodulatory drug, and dexamethasone, a steroid[1].
▸What are the side effects of Ixazomib?
Ninlaro does not carry a boxed warning[1]. The safety numbers below come from the main trial, where 361 people took Ninlaro with lenalidomide and dexamethasone and 359 took placebo with the same 2 drugs[1].
Low platelets are the most common problem. Platelet counts fell in 85% of people on the Ninlaro combination (severe in 30%) versus 67% on placebo (severe in 14%), usually dipping between Days 14 and 21 of each cycle[1].
Other warnings on the label: Diarrhea in 52% versus 43%, constipation in 35% versus 28%, nausea in 32% versus 23% and vomiting in 26% versus 13%[1] Peripheral neuropathy (numbness, tingling or burning in the hands and feet) in 32% versus 24%, mostly mild[1] Swelling of the legs, arms or face (peripheral edema) in 27% versus 21%[1] Rash in 27% versus 16%; Stevens-Johnson syndrome and toxic epidermal necrolysis, severe blistering skin reactions, have been reported, including fatal cases[1] Thrombotic microangiopathy, a rare and sometimes fatal clotting disorder that can damage the kidneys[1] Liver injury, reported in under 1% for each specific type[1] More deaths when Ninlaro was used as maintenance treatment in 2 trials, which is why the label does not recommend that use outside trials[1]
Shingles (herpes zoster) occurred in 6% on Ninlaro versus 3% on placebo, and in only 1% of Ninlaro patients who took antiviral prevention compared with 10% who did not[1]. Eye problems such as cataract, pink eye, blurred vision and dry eye were reported in 38% of people on the Ninlaro combination[1]. About 10% of people stopped Ninlaro permanently because of a side effect[1].
Ninlaro can harm an unborn baby. The label calls for a pregnancy check before starting, non-hormonal birth control for women and birth control for men with partners who could become pregnant, each for 90 days after the last dose, and no breastfeeding for 90 days[1]. Dexamethasone may make hormonal birth control less effective[1].
▸How is Ixazomib taken?
Ninlaro is a capsule taken by mouth once a week on Days 1, 8 and 15 of a 28-day cycle, on the same day and at about the same time each week[1]. The usual starting dose is 4mg, with lenalidomide 25mg on Days 1 to 21 and dexamethasone 40mg on Days 1, 8, 15 and 22[1].
How the label says to take it:
- On an empty stomach, at least 1 hour before or at least 2 hours after food[1]
- Swallowed whole with water, never crushed, chewed or opened[1]
- A missed or late dose is taken only if the next dose is at least 72 hours away, and a dose is never doubled[1]
- A dose that is vomited is not repeated; the next dose is taken on schedule[1]
The label warns that taking more than prescribed has led to deaths, so the schedule matters[1]. Capsules come in 4mg, 3mg and 2.3mg strengths, and the dose steps down from 4mg to 3mg to 2.3mg for side effects[1]. People with moderate or severe liver impairment, severe kidney impairment or kidney failure on dialysis start at 3mg, and Ninlaro can be taken without regard to dialysis timing[1].
Before each new cycle, neutrophils should be at least 1,000/mm3 and platelets at least 75,000/mm3[1]. The label suggests antiviral medicine to lower the risk of shingles and says to avoid strong CYP3A inducers such as rifampin, phenytoin, carbamazepine and St. John's wort[1]. Ninlaro has no REMS program[1].
▸Is Ixazomib FDA approved?
Yes, Ixazomib (Ninlaro) is FDA approved (2015) for the treatment of Multiple Myeloma.
▸Is Ninlaro a chemo pill?
The Ninlaro label calls ixazomib a proteasome inhibitor, a targeted medicine that blocks the cell's protein-recycling machinery[1].
Form: Ninlaro is a capsule taken by mouth once a week at home[1].
Combination: It is always taken with lenalidomide and dexamethasone[1].
Source: Ninlaro prescribing information (DailyMed)
▸How do you take Ninlaro?
Ninlaro is taken once a week on Days 1, 8 and 15 of a 28-day cycle, usually at a 4mg dose[1].
Food: The label says Ninlaro is taken at least 1 hour before or at least 2 hours after food[1].
Swallowing: The label says the capsule is swallowed whole with water and not crushed, chewed or opened[1].
Missed dose: The label says a missed dose is taken only if the next scheduled dose is at least 72 hours away, and 2 doses are never taken at once. Questions about a missed dose go to the care team[1].
Safety: The label says taking too much has led to deaths[1].
Source: Ninlaro prescribing information (DailyMed)
▸Can Ninlaro be used for maintenance therapy?
The Ninlaro label says it is not recommended for maintenance treatment outside controlled clinical trials[1].
Why: In 2 randomized maintenance trials, more people died on Ninlaro (27% versus 26%, and 30% versus 27% on placebo)[1].
Newly diagnosed: The label also does not recommend Ninlaro with lenalidomide and dexamethasone for newly diagnosed myeloma, after a trial missed its goal[1].
Since: These limits were added to the label in April 2022[4].
Source: Ninlaro prescribing information (DailyMed)
▸What are the most common side effects of Ninlaro?
The most common side effects on the Ninlaro label are low platelets, low neutrophils, diarrhea, constipation, nerve damage, nausea, swelling, rash, vomiting and bronchitis[1].
Platelets: Low platelets occurred in 85% on the Ninlaro combination versus 67% on placebo[1].
Stomach: Diarrhea affected 52% versus 43%[1].
Shingles: Antiviral prevention cut shingles to 1% among Ninlaro patients who took it, versus 10% who did not[1].
Source: Ninlaro prescribing information (DailyMed)
▸How much does Ninlaro cost?
A price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Generics: Drugs@FDA lists no generic ixazomib[2].
Co-pay help: Takeda says people with commercial insurance may pay as little as $0 per prescription; government insurance is excluded[14].
Phone: Takeda Oncology Here2Assist at 1-844-817-6468, Option 2[14].
Source: Ninlaro.com financial support page; Drugs@FDA, NDA 208462
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Takeda Pharmaceuticals America, Inc.) · 2026-08. NINLARO (ixazomib) capsules, for oral use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038f2461-834b-4488-9ebd-863c83eef5a7
- U.S. Food and Drug Administration · 2026-11. Drugs@FDA: NINLARO, NDA 208462, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208462
- U.S. Food and Drug Administration · 2015-11-20. NDA 208462 approval letter: Ninlaro (ixazomib) capsules. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208462Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2022-04-28. NINLARO prescribing information approved with supplements S-012 and S-013, including Recent Major Changes dated 4/2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf
- U.S. Food and Drug Administration · 2024-03-01. NDA 208462/S-016 supplement approval: toxic epidermal necrolysis added to Warnings and Precautions. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208462Orig1s016ltr.pdf
- U.S. Food and Drug Administration · 2024-07-01. NDA 208462/S-017 supplement approval: angioedema added to Postmarketing Experience. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208462Orig1s017ltr.pdf
- New England Journal of Medicine · 2016-04-28. Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. https://doi.org/10.1056/NEJMoa1516282
- ClinicalTrials.gov · 2026-11. A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma. https://clinicaltrials.gov/study/NCT01564537
- ClinicalTrials.gov · 2026-11. A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant. https://clinicaltrials.gov/study/NCT02181413
- ClinicalTrials.gov · 2026-11. A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT). https://clinicaltrials.gov/study/NCT02312258
- ClinicalTrials.gov · 2026-11. IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma. https://clinicaltrials.gov/study/NCT01850524
- U.S. National Library of Medicine, DailyMed (Takeda Pharmaceuticals America, Inc.) · 2025-08. VELCADE (bortezomib) for injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1521d321-e724-4ffc-adad-34bf4f44fac7
- U.S. National Library of Medicine, DailyMed (Onyx Pharmaceuticals, Inc., an Amgen subsidiary) · 2025-06. KYPROLIS (carfilzomib) for injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
- Takeda Pharmaceuticals U.S.A., Inc. · 2026-08. Patient Assistance From Takeda Oncology: Here2Assist and Co-Pay Assistance Program. https://www.ninlaro.com/financial-support