This site is intended for US
healthcare professionals only.

Important Safety Information Prescribing Information



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® (ixazomib) 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*
NINLARO® (ixazomib) - Nonhematologic Side Effects
  • Grade 3, NINLARO regimen vs placebo regimen, respectively: upper respiratory tract infection (<1% vs <1%), peripheral neuropathies (2% vs 2%), diarrhea (6% vs 2%), constipation (<1% vs <1%), nausea (2% vs 0%), vomiting (1% vs <1%), rash (3% vs 1%), back pain (<1% vs 3%), peripheral edema (2% vs 1%)
  • Grade 4: ARs reported in the predefined subset were 0% in the NINLARO and placebo regimens
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.
  • Represents a pooling of preferred terms.

Serious ARs

  • Serious ARs reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%)

Additional safety information

  • 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)
  • ARs=adverse reactions.

Hematologic events

Pooled hematologic adverse events and laboratory data for NINLARO® (ixazomib)
NINLARO® (ixazomib) - Hematologic Side Effects

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% and 5%, respectively
  • Discontinuations due to thrombocytopenia were <1% and 2%, respectively

The NINLARO® (ixazomib) regimen represented a sustainable treatment for patients

Discontinuation rates were low and comparable between the NINLARO and placebo regimens
NINLARO® (ixazomib) - Multiple Myeloma Treatment

of patients continued at the starting dose of NINLARO without dose reduction.6