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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, hepatotoxicity, and embryo-fetal toxicity
  • For additional details about these Warnings and Precautions, see the Important Safety Information below.

Nonhematologic adverse reactions

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 eye disorders in the NINLARO and placebo regimens: all grades, 26% vs 16%, respectively; grade 3, 2% vs 1%, respectively
  • NINLARO did not prolong the QTc interval at clinically relevant exposures
  • The majority of peripheral neuropathy ARs were grade 1 (18% vs 14%, respectively)
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
  • Represents a pooling of preferred terms.
  • Based on pharmacokinetic-pharmacodynamic analysis of data from 245 patients.
  • AR=adverse reaction.

Hematologic events

Pooled hematologic adverse events and laboratory data for NINLARO® (ixazomib)
Hematologic adverse events: NINLARO® (ixazomib) vs. placebo
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.

Thrombocytopenia associated with the NINLARO regimen followed a cyclical pattern and typically recovered to baseline by the start of the next cycle

  • Rates of platelet transfusions were 6% with the NINLARO regimen and 5% with the placebo regimen
  • Discontinuations due to thrombocytopenia were <1% with the NINLARO regimen and 2% with the placebo regimen

To learn more about the possible side effects and management strategies for NINLARO, download the GUIDELINES FOR ADMINISTERING NINLARO® (ixazomib).

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

Discontinuation rates were low and 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.9

  • For each adverse reaction, 1 or more of the 3 drugs were discontinued in ≤1% of patients in the NINLARO regimen
  • In the NINLARO arm, the median time on therapy was 17 cycles and 15 cycles in the placebo arm1