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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 ORAL NINLARO+Rd AND Rd IN TOURMALINE-MM11*
Nonhematologic adverse events: NINLARO® (ixazomib) vs. placebo

Additional safety information

  • Serious ARs reported in ≥2% of patients included thrombocytopenia (2%) and diarrhea (2%)1
  • Incidence of thrombocytopenia in patients in the NINLARO and Rd regimens, respectively: any grade, 78% vs 54%; grades 3-4, 26% vs 11%1
  • Incidence of neutropenia in the NINLARO and Rd regimens, respectively: any grade, 67% vs 66%; grades 3-4, 26% vs 30%1
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd 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
  • Defined as patients with del(17p), t(4;14), and/or t(14;16).

The NINLARO® (ixazomib) regimen demonstrated a safety profile amenable to treatment to disease progression1,3

DISCONTINUATION RATES DUE TO ARs WERE SIMILAR TO THOSE IN THE Rd REGIMEN IN TOURMALINE-MM19
13% vs 11% with NINLARO® and Rd regimens, respectively
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
Dose Tolerability
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
  • 8% of high-risk cytogenetic patients discontinued the NINLARO regimen because of adverse events vs 13% with the Rd 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%).