Precautions of Selinexor

1.Thrombocytopenia

selinexor can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications.

2.Neutropenia

selinexor can cause life-threatening neutropenia, potentially increasing the risk of infection.

3.Gastrointestinal Toxicity

selinexor can cause severe gastrointestinal toxicities [see Adverse Reactions (6.1)]. In patients with DLBCL (n=134), gastrointestinal toxicity occurred in 80% of patients with Grade 3 or 4 in 13%.

4.Hyponatremia

selinexor can cause severe or life-threatening hyponatremia.

5.Serious Infection

selinexor can cause serious and fatal infections. Most of these infections were not associated with Grade 3 or higher neutropenia.

6.Neurological Toxicity

selinexor can cause life-threatening neurological toxicities.

7.Embryo-Fetal Toxicity

Based on data from animal studies and its mechanism of action, selinexor can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.

8.Cataract

New onset or exacerbation of cataract has occurred during treatment with selinexor.

from FDA，2022.07