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Selinesol is indicated for the treatment of relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory diffuse large B-cell lymphoma (RR). DLBCL) has demonstrated significant clinical effects, providing patients with new treatment options.
1. Generic name: Selinexor;
2. Trade name: XPOVIO™.
Seliniso combined with dexamethasone is suitable for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), specifically: who have received at least 4 previous treatments. (including alkylating agents, glucocorticoids, bortezomib, carfilzomib, lenalidomide, pomalidomide and anti-CD38 monoclonal antibodies), and patients who are resistant to at least 2 proteasome inhibitors, 2 immunomodulators and anti-CD38 monoclonal antibodies. This indication is based on the accelerated approval process and requires further verification of clinical benefit.
1. Specifications: 20 mg/tablet;
2. Properties: Round biconvex film-coated tablets.
1. Active ingredient: Selinesol;
2. Excipients include colloidal silica, croscarmellose sodium, magnesium stearate, etc.
1. Recommended dosage of : Take 80 mg (4 tablets) orally on the 1st and 3rd day of each week, combined with 20 mg of dexamethasone.
2. How to take : Swallow the tablet whole. Do not break, chew or crush it. It is recommended to take the medicine at a fixed time. If you miss a dose or vomit, you do not need to take it again. You can take the medicine next time as originally planned.
3. Monitoring requirements : In the early stage of treatment, blood routine, blood sodium and body weight need to be monitored frequently (the first 2 months are particularly critical).
1. Thrombocytopenia : Interrupt or reduce the dose according to the severity (if platelets <25,000/μL, pause).
2. Neutropenia : When febrile neutropenia occurs, it is necessary to suspend and adjust the dose.
3. Gastrointestinal toxicity : For severe nausea/vomiting or diarrhea, the dose needs to be reduced and anti-emetic/anti-diarrheal support should be strengthened.
4. Hyponatremia : Intervention and dose adjustment are required when blood sodium is ≤130mmol/L.
5. Other adverse reactions : Such as fatigue, significant weight loss, etc., which need to be adjusted according to the grade.
1. Diet : It can be taken with food, but sufficient water and calorie intake must be maintained to prevent dehydration or weight loss.
2. Pretreatment : It is recommended to use 5-HT3 antagonist to prevent nausea and vomiting.
3. Concomitant use of is contraindicated: Avoid combined use with other drugs that may cause dizziness or mental state.
4. Special reminder : Avoid driving or operating machinery while taking the medicine, as it may cause dizziness or confusion.
1. Pregnancy/breastfeeding : It has embryo-fetal toxicity and is contraindicated in pregnant women; patients of childbearing age need to use effective contraception (during treatment and 1 week after stopping the drug). Not allowed during lactation.
2. Elderly patients : Patients aged ≥75 years have a higher risk of adverse reactions and require close monitoring.
3. Hepatic and renal insufficiency : No dose adjustment is required for mild to moderate symptoms, and insufficient data for severe symptoms.
1. Common (≥20%) include: Thrombocytopenia, fatigue, nausea, anemia, decreased appetite, weight loss, diarrhea, vomiting, hyponatremia, neutropenia, etc.
2. Serious adverse reactions may include: Bleeding, infection, nervous system toxicity (such as confusion) and dehydration-related complications.
There are no absolute contraindications, but the patient’s basic condition and concomitant medication need to be carefully evaluated.
1. CYP3A4 substrate : Selinisol is metabolized by CYP3A4, so caution should be used in combination with strong CYP3A4 inhibitors/inducers.
2. UGT/GST metabolism : may be affected by related enzyme regulators.
Store below 30°C (86°F), in original packaging to prevent moisture and light.