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