Selinor Tablet

Warnings & Precautions

Thrombocytopenia: Selinex can cause thrombocytopenia, which can lead to bleeding that may be fatal. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3-4) thrombocytopenia occurred in 61% of patients treated with Selinex. The median time to the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding in 5%, and fatal hemorrhage in less than 1% of patients. Platelet counts should be checked at baseline, during treatment, and as clinically indicated, and more often in the first two months. Platelet transfusion and/or other treatments should be started as clinically indicated. Watch patients for signs and symptoms of bleeding and evaluate them promptly. Depending on how severe the reaction is, interrupt the dose, reduce it, or stop treatment permanently. Neutropenia: Selinex can cause neutropenia, which may raise the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3-4) neutropenia occurred in 21% of patients treated with Selinex. The median time to the first event was 25 days. Febrile neutropenia was reported in 3% of patients. Neutrophil counts should be taken at baseline, during treatment, and as clinically indicated, and more often in the first two months. Watch patients for signs and symptoms of concomitant infection and evaluate them promptly. Supportive measures can be considered, including antimicrobials for signs of infection and growth factors (e.g., G-CSF). Depending on severity, interrupt the dose, reduce it, or stop treatment permanently. Gastrointestinal toxicity: Gastrointestinal toxicities occurred in patients treated with Selinex. Nausea and vomiting: Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9%. The median time to the first nausea event was 3 days. Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4%. The median time to the first vomiting event was 5 days. Give 5-HT3 antagonists and/or other anti-nausea agents as prevention, before and during treatment with Selinex. Manage nausea and vomiting by interrupting the dose, reducing it, and/or stopping treatment. Give intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti-nausea medicines as clinically indicated. Diarrhea: Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6%. The median time to onset was 15 days. Manage diarrhea with dose modifications and/or standard anti-diarrheal agents, and give intravenous fluids to prevent dehydration in patients at risk. Anorexia and weight loss: Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5%. The median time to onset of anorexia was 8 days. Weight loss was reported in 47% of patients, and Grade 3 weight loss occurred in 1%. The median time to onset of weight loss was 15 days. Weigh the patient at baseline, during treatment, and as clinically indicated, and more often in the first two months. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support. Hyponatremia: Selinex can cause hyponatremia. It occurred in 39% of patients treated with Selinex, and 22% had Grade 3 or 4 hyponatremia. The median time to the first event was 8 days. Check the sodium level at baseline, during treatment, and as clinically indicated, and more often in the first two months. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and for high serum paraprotein levels. Treat hyponatremia according to clinical guidelines (intravenous saline and/or salt tablets), including a review of the diet. Depending on severity, interrupt the dose, reduce it, or stop treatment permanently. Infections: In patients receiving Selinex, 52% had an infection of any grade. Upper respiratory tract infection of any grade occurred in 21% of patients, pneumonia in 13%, and sepsis in 6%. Grade 3 or higher infections were reported in 25% of patients, and deaths from infection occurred in 4%. The most common Grade 3 or higher infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not linked to neutropenia and were caused by non-opportunistic organisms. Neurological toxicity: Neurological toxicities occurred in patients treated with Selinex. Neurological adverse reactions, including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state), occurred in 30% of patients, and severe events (Grade 3-4) occurred in 9%. The median time to the first event was 15 days. Review and adjust hydration status, hemoglobin level, and concomitant medicines so that they don't make dizziness or mental status changes worse. Embryo-fetal toxicity: Animal studies and the mechanism of action show that Selinex can cause fetal harm when given to a pregnant woman. When pregnant animals were given Selinex during organogenesis, it resulted in structural abnormalities and changes in growth, at exposures below those seen clinically at the recommended dose. Pregnant women should be told about the potential risk to the fetus. Females of reproductive potential, and males with a female partner of reproductive potential, should be advised to use effective contraception during treatment with Selinex and for 1 week after the last dose.