Your Health, We Care
Another NameNINLARO、LuciXaz、 伊沙佐米、恩莱瑞
IndicationsIxazomab is suitable for the treatment of multiple myeloma.
Reg No.10 L 1026/23
Inspection NO.
Ixazomib is an oral, highly selective proteasome inhibitor developed by Takeda Pharmaceutical Company in Japan.Ixazomib was approved for market by the FDA on November 20, 2015.
The Ixazomab produced by Lucius, Laos has a specification of 4mg*3 capsules and a registration number of 10 L 1026/23 filed with the Drug Administration.
Based on the results of an international, randomized, double-blind clinical trial, the treatment regimen of Ixazomab combined with lenalidomide and dexamethasone significantly prolonged the disease-free progression period in patients with multiple myeloma.
Ixazomib
Adult patients with multiple myeloma.
Based on its mechanism of action and data from animal reproduction studies, Ixazomib can cause fetal harm when administered to a pregnant woman.There are no available data on Ixazomib use in pregnant women to evaluate drug-associated risk. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose. Advise pregnant women of the potential risk to a fetus.
There are no data on the presence of ixazomib or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions from Ixazomib in a breastfed infant, advise women not to breastfeed during treatment with Ixazomib and for 90 days after the last dose.
Females
Advise females of reproductive potential to use effective non-hormonal contraception during treatment with Ixazomib and for 90 days after the last dose. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because Ixazomib is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered.
Males
Advise males with female partners of reproductive potential to use effective contraception during treatment with Ixazomib and for 90 days after the last dose.
Safety and effectiveness of Ixazomib have not been established in pediatric patients.
Of the total number of subjects in clinical studies of Ixazomib, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of Ixazomib in patients with moderate or severe hepatic impairment.
In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of Ixazomib in patients with severe renal impairment or ESRD requiring dialysis. Ixazomib is not dialyzable and therefore can be administered without regard to the timing of dialysis.
Overdosage, including fatal overdosage, has been reported in patients taking Ixazomib. Manifestations of overdosage include adverse reactions reported at the recommended dosage. Serious adverse reactions reported with overdosage include severe nausea, vomiting, diarrhea, aspiration pneumonia, multiple organ failure and death.
In the event of an overdosage, monitor for adverse reactions and provide appropriate supportive care. Ixazomib is not dialyzable.
Store Ixazomib at room temperature. Do not store above 30°C (86°F). Do not freeze. Store capsules in original packaging until immediately prior to use.
A food effect study conducted in patients with a single 4 mg dose of ixazomib showed that a high-fat meal decreased ixazomib AUC by 28% and Cmax by 69%.
from FDA,2024.07
