NINLARO® (ixazomib) Safety Profile

The NINLARO triplet regimen* demonstrated a safety profile appropriate for long-term treatment.1,2

*The NINLARO regimen includes NINLARO+lenalidomide+dexamethasone.3
Used herein to refer to treatment to disease progression or unacceptable toxicity.3

Warnings and Precautions

  • Thrombocytopenia: Monitor platelet counts at least monthly during treatment and adjust dosing, as needed
  • Gastrointestinal Toxicities: Adjust dosing for severe diarrhea, constipation, nausea, and vomiting, as needed
  • Peripheral Neuropathy: Monitor patients for symptoms of peripheral neuropathy and adjust dosing, as needed
  • Peripheral Edema: Monitor for fluid retention. Investigate for underlying causes, when appropriate. Adjust dosing, as needed
  • Cutaneous Reactions: Monitor patients for rash and adjust dosing, as needed. Stevens-Johnson syndrome, including a fatal case, has been reported with NINLARO
  • Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue NINLARO if suspected. Cases, sometimes fatal, have been reported with NINLARO
  • Hepatotoxicity: Monitor hepatic enzymes during treatment
  • Embryo-Fetal Toxicity: NINLARO can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective non-hormonal contraception
  • Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting: Treatment of patients with NINLARO for multiple myeloma in the maintenance setting is not recommended outside of controlled trials

For additional details about these Warnings and Precautions, see the Important Safety Information below.

Adverse Reactions

The NINLARO regimen* demonstrated a safety profile comparable to the Rd regimen*3

Non-hematologic ARs occurring in ≥5% of patients with a ≥5% difference between oral NINLARO+Rd and Rd in TOURMALINE MM13

Common ARs with the NINLARO® (ixazomib) regimen include: diarrhea, constipation, peripheral neuropathies, nausea, back pain, peripheral edema, rash, upper respiratory tract infection, vomiting, and bronchitis.
  • Incidence of thrombocytopenia in patients in the NINLARO and Rd regimens, respectively: any grade, 85% vs 67%; grades 3-4, 30% vs 14%3 
  • Incidence of neutropenia in the NINLARO and Rd regimens, respectively: any grade, 74% vs 70%; grades 3-4, 34% vs 37%3

Safety in high-riskpatient population

  • The overall safety profiles in the high-risk and standard-risk cytogenetics patients in each group are consistent with data reported for the overall population2
  • 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 anemia2

*Defined as patients with del(17p), t(4;14), and/or t(14;16).4

SERIOUS ADVERSE REACTIONS

Serious ARs reported in ≥2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%) and bronchitis (2%)3 

*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.3
Represents a pooling of preferred terms.3
At the time of the final analysis, these adverse reactions no longer met the criterion for a ≥5% difference between the NINLARO+Rd regimen and Rd regimen.3
AR=adverse reaction; PI=proteasome inhibitor.

Discontinuation Rates

In TOURMALINE-MM1, discontinuation rates due to ARs were similar across regimens1

13% vs 11% discontinuation rates with the NINLARO® (ixazomib) regimen and Rd regimen, respectively.

With the NINLARO and Rd regimens*, respectively,

Dose tolerability

The majority of patients continued at the starting dose of NINLARO without dose reduction1

80% of patients continued at the starting dose of the NINLARO® (ixazomib) regimen without dose reduction.

of patients receiving the NINLARO regimen in TOURMALINE-MM1 continued on their starting NINLARO dose

  • The median dose intensity for NINLARO and placebo was high and similar in the NINLARO and Rd regimens*: 97.4% and 98.2%, respectively
  • Relative dose intensity was calculated as 100 x (total amount of dose taken/total planned dose over treated cycles)

*The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.3

NINLARO prescribing information

Learn about important information before prescribing NINLARO.

NINLARO clinical trial data

The TOURMALINE-MM1 trial evaluated efficacy and safety of the all-oral NINLARO regimen vs Rd regimen in relapsed patients with multiple myeloma.