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NINLARO® (ixazomib) capsules 4mg I 3mg I 2.3mg

VELCADE® (bortezomib) FOR INJECTION

This site is intended for US healthcare professionals only.

Important Safety Information Prescribing Information
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This site is intended for US
healthcare professionals only.

Important Safety Information Prescribing Information

NINLARO® (ixazomib) capsules 4mg I 3mg I 2.3mg

VELCADE® (bortezomib) FOR INJECTION

This site is intended for US healthcare professionals only.

Important Safety Information Prescribing Information

SAFETY

Indication: 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.

Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials.

Warnings and Precautions

  • Warnings and Precautions associated with NINLARO include thrombocytopenia, gastrointestinal toxicities, peripheral neuropathy, peripheral edema, cutaneous reactions, thrombotic microangiopathy, hepatotoxicity, embryo-fetal toxicity, and Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting
  • 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*
NINLARO+Rd* (n=361) Rd* (n=359)
AR All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
Diarrhea 52% 10% 0 43% 3% 0
Constipation 35% <1% 0 28% <1% 0
Peripheral neuropathies 32% 2% 0 24% 2% 0
Nausea 32% 2% 0 23% 0 0
Edema peripheral 27% 2% 0 21% 1% 0
Back pain 27% <1% 0 24% 3% 0
Rash 27% 3% 0 16% 2% 0
Upper respiratory tract infection 27% 1% 0 23% 1% 0
Vomiting 26% 1% 0 13% <1% 0
Bronchitis 22% 2% 0 17% 2% <1%

Additional safety information

  • Serious ARs reported in ≥2% of patients included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%)1
  • Incidence of thrombocytopenia in patients in the NINLARO and Rd regimens, respectively: any grade, 85% vs 67%; grades 3-4, 30% vs 14%1
  • Incidence of neutropenia in the NINLARO and Rd regimens, respectively: any grade, 74% vs 70%; grades 3-4, 34% vs 37%1
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • Represents a pooling of preferred terms.
  • 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.
  • AR=adverse reaction.

The NINLARO® (ixazomib) regimen demonstrated a safety profile appropriate to treatment to disease progression1

IN TOURMALINE-MM1, DISCONTINUATION RATES DUE TO ARs WERE SIMILAR ACROSS REGIMENS7
13% vs 11% with NINLARO® and Rd regimens, respectively

Safety in high-risk patient 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 population8
  • 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 anemia8
  • *The NINLARO regimen included NINLARO+lenalidomide+dexamethasone. The Rd regimen included placebo+lenalidomide+dexamethasone.
  • Defined as patients with del(17p), t(4;14), and/or t(14;16).
Dose Tolerability

The majority of patients continued at the starting dose of NINLARO without dose reduction7

80%

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.

The most common adverse reactions (≥ 20%) in the NINLARO regimen compared to placebo in combination with lenalidomide plus dexamethasone, respectively were thrombocytopenia (85%, 67%; pooled from adverse event and laboratory data), neutropenia (74%, 70%; pooled from adverse event and laboratory data), diarrhea (52%, 43%), constipation (35%, 28%), peripheral neuropathy (32%, 24%), nausea (32%, 23%), edema peripheral (27%, 21%), rash (27%, 16%), vomiting (26%, 13%), and bronchitis (22%, 17%). Serious adverse reactions reported in ≥ 2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%).