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Important Safety Information Prescribing Information

Safety

SAFETY

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

Warnings and Precautions

  • Warnings and Precautions associated with NINLARO include thrombocytopenia, gastrointestinal toxicities, peripheral neuropathy, peripheral edema, cutaneous reactions, thrombotic microangiopathy, hepatotoxicity, and embryo-fetal toxicity
  • For additional details about these Warnings and Precautions, see the Important Safety Information below.

Selected safety profile

Nonhematologic ARs occurring in 5% of patients with a 5% difference between the NINLARO® (ixazomib) regimen* and the placebo regimen*
Nonhematologic adverse events: NINLARO® (ixazomib) vs. placebo

Additional safety information

  • Serious ARs reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%)
  • Incidence of thrombocytopenia in patients in the NINLARO and placebo regimens, respectively: any grade, 78% vs 54%; grades 3-4, 26% vs 11%
  • Incidence of neutropenia in the NINLARO and placebo regimens, respectively: any grade, 67% vs 66%; grades 3-4, 26% vs 30%
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
  • Represents a pooling of preferred terms.
  • AR=adverse reaction.

Overall safety profile among high-risk and standard-risk cytogenetics patients10

  • The overall safety profiles in the high-risk and standard-risk cytogenetics patients in each group are consistent with data reported for the overall population
  • As seen in the overall population, in both high-risk and standard-risk cytogenetics patients, common adverse events were primarily of grade 1 or 2 severity and included diarrhea, constipation, neutropenia, and anemia
  • Rates of adverse events of clinical importance were also consistent with previous reports

To learn more about the possible side effects and management strategies for NINLARO, DOWNLOAD THE TREATMENT CONSIDERATIONS WITH NINLARO® (ixazomib).

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The NINLARO® (ixazomib) regimen demonstrated a safety profile amenable to treatment to disease progression

DISCONTINUATION RATES WERE COMPARABLE BETWEEN THE NINLARO AND PLACEBO REGIMENS*
Discontinuation rates of entire regimen due to adverse reactions: NINLARO® (ixazomib) vs placebo
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
80%

of patients continued at the starting dose of NINLARO without dose reduction.11

  • For each adverse reaction, 1 or more of the 3 drugs were discontinued in ≤1% of patients in the NINLARO regimen
  • The median time on therapy for patients in the NINLARO arm was 17 cycles compared with 15 cycles for patients in the placebo arm1
  • 8% of high-risk cytogenetic patients discontinued the NINLARO regimen because of adverse events vs 13% with the placebo regimen10
  • Defined as patients with del(17p), t(4;14), and/or t(14;16).

The most common adverse reactions (≥20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%).