Method of administration and dosage
Intravenously, irrespective of food intake.
If a dose is missed, it should be taken as soon as possible, but avoiding duplication (if it is close to time for the next dose).
Exceeding a daily dose >2.5 mg may increase the systemic effects of the drug.
Adults. The recommended dose of the drug is 2.5 mg once daily on a daily, long-term basis.
As prolonged adjuvant therapy, treatment should be continued for 5 years (not longer than 5 years).
If signs of progression appear, the drug should be discontinued.
In neoadjuvant treatment (pre-operative period), treatment with the drug should be continued for 4-8 months to achieve optimal tumour size reduction. If an adequate tumour response to treatment is not achieved, the drug should be discontinued and surgery or other treatments considered.
Patients with hepatic impairment
No dose adjustment is required for mild to moderate hepatic impairment (Child-Pugh class A or B). There are insufficient data on the use in patients with severe hepatic impairment (Child-Pugh class C), therefore use in such patients should be under continuous medical supervision.
Patients with renal impairment
No dose adjustment is required for renal impairment (creatinine clearance ≥10 ml/min). Data on use in patients with creatinine clearance <10 ml/min are insufficient.
Patients ≥65 years of age
No dose adjustment is required in elderly patients.