Jeselhy Special Precautions

Severe diarrhoea: In the JESELHY clinical program, there have been reports of serious renal disorders resulting from dehydration due to diarrhoea.
It is not possible to predict which patients will develop this event. Special attention should be paid to the symptom and consequences of diarrhoea, particularly dehydration and acute kidney injury. Antidiarrheal agents should be used as necessary. Electrolytes should be monitored carefully and fluid replacement considered in order to prevent dehydration and electrolyte shift. Dose modifications (interruption and/or reduction) should be applied as necessary.
Eye disorder: Eye disorder may occur.
Eye disorder should be closely monitored during administration. Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms. Dose interruption/dose reduction should be considered as necessary.
Haemorrhage: Serious ADRs of duodenal ulcer haemorrhage and intra-abdominal haemorrhage were reported.
It is not possible to predict which patients will develop this event. Special attention should be paid to the symptom of haemorrhage. Dose modifications (interruption and/or reduction) should be applied as necessary.
Effects on ability to drive and use machines: There was no report of the effects of JESELHY on the ability to drive or use machines from the studies that have been conducted so far.
Use in Pregnancy: Embryo-fetal toxicity: In an embryo-fetal development toxicity study in rats, growth inhibition, teratogenicity, and embryo-fetal lethality were observed in pregnant rats treated with 4 mg/kg of pimitespib. Although the plasma concentration of pimitespib in pregnant rats is unknown, the plasma concentration of unbound pimitespib at 4 mg/kg in non-pregnant female rats was 0.9-1.5 times and 0.6-1.0 times of that at the clinical therapeutic dose in terms of C_max and AUC, respectively. Therefore, it is possible that even the clinical therapeutic dose may affect embryos and fetuses. Genotoxicity studies showed that pimitespib induced chromosomal structural abnormalities, but did not induce mutagenicity or chromosomal numerical aberration.
There are no clinical data on embryo fetal toxicity from the clinical trials.
Since GIST progressed after chemotherapy has a poor prognosis and other treatment options are extremely limited, it is considered that it is acceptable to administer JESELHY with caution to pregnant women or women who may be pregnant, provided that the potential risks to the fetus are fully explained to the patient and her family, and only when the therapeutic benefits are judged to outweigh the risks.