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

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

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

• ^*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The placebo regimen included placebo+lenalidomide+dexamethasone.

• 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%).