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Reports of thrombocytopenia have been documented in patients treated with ixazomib (NINLARO). The nadir of platelet count generally occurs between days 14 and 21 of each 28-day treatment cycle and can recover to baseline levels before the start of the next cycle. In the ixazomib treatment group, the reported incidence rates of grade 3 and grade 4 thrombocytopenia were 17% and 13%, respectively. During treatment, platelet counts should be monitored at least once a month; in the first three cycles of treatment, the frequency of monitoring should be considered for an increase. Intervention and management of thrombocytopenia should be conducted in accordance with standard clinical guidelines by adjusting the dosage of the medication and performing platelet transfusions.
Gastrointestinal toxicities, including diarrhea, constipation, nausea, and vomiting, have occurred in patients treated with ixazomib. In occasional cases, the use of antidiarrheal and antiemetic drugs, combined with supportive care measures, is required. In the ixazomib treatment group, 3% of patients discontinued one or more of the three drugs due to diarrhea, compared with 2% in the placebo group. If patients develop grade 3 or grade 4 gastrointestinal symptoms, the dosage of the medication should be adjusted promptly.
Reports of peripheral neuropathy have been observed in patients receiving ixazomib treatment. Among the adverse reactions, peripheral sensory neuropathy is the most frequently reported, with incidence rates of 24% in the ixazomib treatment group and 17% in the placebo group. The incidence of peripheral motor neuropathy is low in both groups (<1%). In the ixazomib treatment group, 4% of patients discontinued one or more of the three drugs due to peripheral neuropathy, whereas the proportion in the placebo group was less than 1%. During treatment, close monitoring is required for signs and symptoms related to neuropathy. If patients develop new-onset peripheral neuropathy or experience exacerbation of existing symptoms, consideration should be given to adjusting the dosage of the medication.
Reports of peripheral edema have been noted in patients treated with ixazomib. Clinically, potential causes of edema need to be identified, and supportive care should be provided based on the actual situation. If patients present with grade 3 or grade 4 edema symptoms, the dosage of ixazomib should be adjusted; alternatively, the dosage of dexamethasone can be adjusted in accordance with its product labeling.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients treated with ixazomib, some of which have even resulted in death. Once SJS or TEN is confirmed, ixazomib should be discontinued immediately, and clinically indicated interventions should be implemented. Rashes have also been reported in the ixazomib treatment group, with maculopapular rash and macular rash being the most common types. The proportion of patients who discontinued one or more of the three drugs due to rash was less than 1% in both the ixazomib treatment group and the placebo group. For grade 2 or higher rashes, supportive care measures can be adopted, or intervention management can be carried out by adjusting the dosage of the medication.
Reports of thrombotic microangiopathy have been recorded in patients treated with ixazomib. Some patients receiving ixazomib have developed fatal cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). Clinically, it is necessary to monitor patients for signs and symptoms associated with TTP/HUS. If there is a high suspicion of TTP/HUS in a patient, the safety of re-administering ixazomib to patients with a history of TTP/HUS has not been established to date.
Reports of hepatotoxicity have been documented in patients treated with ixazomib. The incidence rates of drug-induced liver injury, hepatocellular injury, hepatic steatosis, cholestatic hepatitis, and hepatotoxicity in patients receiving ixazomib treatment are all less than 1%. The overall reported incidence of hepatotoxicity was 10% in the ixazomib treatment group and 9% in the placebo group. Clinically, liver function parameters should be monitored regularly. If patients develop grade 3 or grade 4 hepatotoxic reactions, the dosage of the medication should be adjusted in a timely manner.
Ixazomib has embryo-fetal toxicity and may cause harm to the fetus. Pregnant women should be informed of the potential risk of this drug to the fetus. Women of childbearing potential should be advised to use effective non-hormonal contraception during ixazomib treatment and for 90 days after the last dose. Meanwhile, men with female partners of childbearing potential should be reminded to use effective contraception during ixazomib treatment and for 90 days after the last dose.
In two prospective randomized clinical trials of maintenance therapy for multiple myeloma, an increased mortality rate was observed in patients treated with ixazomib. Unless within the scope of strictly controlled clinical trials, ixazomib is not recommended for the maintenance treatment of patients with multiple myeloma.
from FDA,2024.07
Ixazomib has been approved by the U.S. Food and Drug Administration (FDA) for th···【more】
Release date：2026-01-08Recommended：35
Ixazomib is available in capsule dosage form and is a prescription-only medicine···【more】
Release date：2026-01-08Recommended：37
