We're glad you were able to join us for NINLARO® (ixazomib): an oral treatment option, an ION-hosted Takeda presentation about NINLARO® (ixazomib).
Below is additional information and data that we think you
might find interesting.
NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
NINLARO is a highly active agent
The NINLARO regimen (NINLARO+lenalidomide+dexamethasone) extended median PFS by ~6 months vs the placebo regimen.
Depth of response for the NINLARO vs placebo regimens: ORR: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; PR: 30% vs 33%, respectively‡
Warnings and Precautions associated with NINLARO include thrombocytopenia, gastrointestinal toxicities, peripheral neuropathy, peripheral edema, cutaneous reactions, hepatotoxicity, and
For more information about these Warnings and Precautions, including additional NINLARO (ixazomib) Important Safety Information, please see below.
The NINLARO regimen included NINLARO, lenalidomide, and dexamethasone. The placebo regimen included placebo, lenalidomide, and dexamethasone.
TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and efficacy of NINLARO (an oral PI) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.1
ORR=CR+PR, including VGPR.
NINLARO achieved rapid responses
Nonhematologic ARs occurring in ≥5% of patients with a ≥5% difference between the NINLARO regimen (n=360) and the placebo regimen (n=360):
All grades, grade 3 (respectively): upper respiratory (19%, <1% vs 14%, <1%), peripheral neuropathies§ (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash§
(19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%)
No grade 4 nonhematologic ARs occurred in either regimen
Serious ARs reported in ≥2% of patients included thrombocytopenia
(2%) and diarrhea (2%)
IMPORTANT SAFETY INFORMATION FOR NINLARO® (ixazomib)
WARNINGS AND PRECAUTIONS
Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.
Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.
Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.
Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.
Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification.
Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.
Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.
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%).
Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.
Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.
Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.
DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.
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