Formulation and Specifications: Tablets: 10mg, 50mg, 100mg
Indications: In combination with azacitidine for the treatment of newly diagnosed adult patients with acute myeloid leukemia who are unfit to receive strong induction chemotherapy due to comorbidities or who are ≥75 years of age.
Key points for rational drug use:
1. The combination of this product with azacitidine for the treatment of AML requires a dose creep at the beginning of the 1st course of treatment with Venecla 100 mg d1, 200 mg d2, 400 mg d3, followed by 400 mg/d to continue treatment for 28 days per course. This product is administered in combination with azacitidine according to the course of treatment until disease progression or intolerable toxic reactions occur.
2. This product should be taken within 30 minutes after a meal.
3. This product should be taken at the same time each day if possible.
4. This product should be swallowed whole and should not be chewed, crushed or broken before swallowing.
5. If a patient misses a dose of this product within 8 hours of the regular dosing time, the patient should make up the dose as soon as possible and resume the regular daily dosing. If the patient has missed a dose of this product for more than 8 hours, no make-up dose is required and regular dosing should be resumed only on the following day. If vomiting occurs after normal dosing, the patient does not need to take the product again on the day of vomiting and the next dose will be given at the regular dosing time.
6. The risk of tumor lysis syndrome in AML patients is relatively low, but it should still be taken seriously. It is recommended that patients should have a white blood cell count of less than 25×109/L and correct disturbed electrolytes prior to the administration of this product. Adequate hydration and antihyperuricemic agents should be given prior to the first dose and during the dose creep period. Blood biochemistry should be monitored to assess for tumor lysis syndrome 6 to 8 hours after each new dose is administered during the creep period and 24 hours after the final dose is reached. For patients at risk for tumor lysis syndrome, additional measures may be given to enhance tumor lysis syndrome prophylaxis.
7. Hematologic toxicity is the most common adverse effect of vinpocetine. Treatment with this product should not be interrupted until remission is achieved with induction therapy, even if grade 4 hematocrit occurs. If grade 4 hematocrit reoccurs during the first course of treatment after remission and persists for more than 7 days, it is still recommended to adhere to the full dose for the full course of treatment, delay the start of the next course of treatment after the end of treatment, monitor blood counts, and wait for the hematocrit to return to grade 1 or 2 before resuming subsequent treatment with this product and azacitidine at the same dose. If grade 4 hematocrit occurs again during the follow-up course and persists for more than 7 days, consider reducing the course of Vinecla from 28 days to 21 days, monitoring the hematocrit, and waiting for the hematocrit to return to grade 1 or 2 before starting the follow-up treatment.
8. Dose adjustment should be made accordingly when this product is used in combination with CYP3A inhibitors. When this product is used in combination with strong CYP3A inhibitors (such as itraconazole, voriconazole, ketoconazole, etc.), the dose of Vinecla should be reduced to 100mg/d. If it is in the dose creeping period, the dose reduction method is: Vinecla 10mg d1, 20mg d2, 50mg d3, 100mg d4; Posaconazole is also a strong CYP3A inhibitor, but when used in combination with Posaconazole, the dose of Vinecla should be reduced to 70mg/d. However, when combined with posaconazole, Vinecla should be reduced to 70mg/d. If it is in dose creep, the reduction method is: Vinecla 10mg d1, 20mg d2, 50mg d3, 70mg d4; when combined with intermediate CYP3A inhibitors (such as fluconazole, etc.) and P-glycoprotein inhibitors (such as amiodarone, captopril, etc.), Vinecla should be reduced by 50%. The combination of this product with CYP3A inducers (such as rifampin, phenytoin sodium, carbamazepine, etc.) is prohibited. If this product is used in combination with P-glycoprotein substrates (such as digoxin) and warfarin, the blood concentration, INR and other corresponding indexes of the combined drugs should be closely monitored.
9. Patients with mild to moderate severe renal impairment (creatinine clearance ≥15ml/min) do not need dose adjustment. No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. For patients with severe hepatic impairment (Child-Pugh Class C), reduce the dose of this product by 50%.