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Dose adjustment regimen for selinexor in the treatment of diffuse large B-cell lymphoma

General dose adjustment:

· Starting dose: 60 mg on days 1 and 3 of each week (120 mg total per week).

· First dose reduction: If dose reduction is necessary, reduce the dose to 40 mg on days 1 and 3 of each week (80 mg total per week).

· Second dose reduction: Further reduce to only once a week at a dose of 60 mg.

· Third dose reduction: Reduce again to once a week at a dose of 40 mg.

· Fourth dose reduction: If still not tolerated, consider permanent discontinuation of treatment.

Dose adjustment for hematological adverse reactions:

Thrombocytopenia:

· Platelet count between 50,000 and 75,000/mcL: If any adverse reaction occurs, interrupt the drug for one dose and restart at the original dose.

· Platelet count between 25,000 and 50,000/mcL without bleeding: At first occurrence, interrupt treatment and monitor until platelet count recovers to at least 50,000/mcL, then reduce by one dose level.

· Platelet count between 25,000 and 50,000/mcL with bleeding: Immediately interrupt treatment, monitor platelet count until recovery to at least 50,000/mcL, and restart at one-level lower dose after bleeding resolves, while considering platelet transfusions per medical guidelines.

· Platelet count below 25,000/mcL: Immediately interrupt treatment and continue monitoring until platelet count recovers to at least 50,000/mcL, then restart treatment at one-level lower dose, while administering platelet transfusions as needed.

Neutropenia:

· Absolute neutrophil count between 0.5 and 1 x 10(9)/L, afebrile: interrupt treatment at first occurrence, monitor until neutrophil count recovers to 1 x

10(9)/L or greater, then restart at original dose. If recurrence occurs, interrupt treatment, monitor until neutrophil count recovers, administer growth factors as directed, then restart at one-step lower dose.

· Absolute neutrophil count less than 0.5 x 10(9)/L or febrile neutropenia: interrupt treatment immediately, monitor until neutrophil count recovers to 1 x

10(9)/L, then restart at one-step lower dose.

Anemia:

· Hemoglobin less than 8 g/dL: In all cases, reduce dose by one level and consider transfusion as directed.

· If life-threatening anemia occurs: treatment should be interrupted immediately and hemoglobin levels should be continuously monitored until it returns to 8g/dL or above, then treatment should be restarted at a lower dose, with blood transfusions as needed.

Dosage adjustment regimen for non-hematological adverse reactions

Nausea and vomiting:

· Grade 1 or 2 nausea (manifested by reduced oral intake, but without significant weight loss, dehydration, or malnutrition) or grade 1 or 2 vomiting (vomiting 5 times or less per day): When these symptoms occur, treatment should be continued and anti-nausea drugs should be added.

· Grade 3 nausea (inadequate oral caloric or fluid intake) or grade 3 or higher vomiting (vomiting 6 times or more per day): Once these symptoms occur, treatment should be interrupted immediately; continue to monitor until nausea or vomiting is relieved to grade 2 or lower, or returns to baseline levels; add anti-nausea drugs; then restart treatment with a regimen that is reduced by 1 dose level.

Diarrhea:

· Grade 2 diarrhea (4 to 6 bowel movements per day compared to baseline): When it first occurs, continue treatment and provide supportive care; if it recurs, reduce the dose by 1 level and provide supportive care.

· Grade 3 or higher diarrhea (7 or more bowel movements per day compared to baseline, requiring hospitalization): Once it occurs, interrupt treatment immediately and provide supportive care; continue to monitor until diarrhea resolves to Grade 2 or lower; then restart treatment at a dose level reduced by 1 level.

Weight loss and anorexia:

· Weight loss of 10% to 20%, or anorexia with significant weight loss or malnutrition: Once these symptoms occur, interrupt treatment and provide supportive care; continue to monitor until weight returns to more than 90% of baseline weight; then restart treatment at a dose level reduced by 1 level.

Hyponatremia:

· Sodium level drops to 130mmol/L or below: Once it occurs, treatment should be interrupted immediately and supportive care should be provided; continue to monitor until the sodium level returns to 130mmol/L or above; then restart treatment at a dose level lower.

Fatigue:

· Grade 2 fatigue lasting more than 7 days or reaching grade 3 fatigue: Once these symptoms occur, treatment should be interrupted; continue to monitor until fatigue is relieved to grade 1 or returns to baseline levels; then restart treatment at a dose level lower.

Ocular toxicity:

· Grade 2 ocular toxicity (excluding cataracts): Once it occurs, an ophthalmological evaluation should be performed, treatment should be interrupted and supportive care should be provided; continue to monitor until ocular symptoms are relieved to grade 1 or return to baseline levels; then restart treatment at a dose level lower.

· Grade 3 or higher ocular toxicity (excluding cataracts): Once it occurs, treatment should be permanently discontinued and an ophthalmological evaluation should be performed.

Other non-hematological adverse reactions:

· Grade 3 or 4 (life-threatening) adverse reactions: If they occur, treatment should be interrupted immediately; continue to monitor until symptoms are relieved to grade 2 or lower; then restart treatment with a dose-reduced regimen.