Anlotinib Hydrochloride Capsules

Calculated as anlotinib (C23H22FN3O3): (1) 12 mg; (2) 10 mg; (3) 8 mg.

This product should be used under the guidance of a physician with experience in the use of anti-tumor drugs.
(1) Recommended dose and method of administration
The recommended dose of anlotinib hydrochloride is 12 mg once a day, orally before breakfast. Take the drug continuously for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment. Until the disease progresses or intolerable adverse reactions occur. During medication, if a dose is missed, confirm that the next dose is less than 12 hours away, then no more doses will be taken.
(2) Dose adjustment
During the use of this product, adverse reactions should be closely monitored and adjusted according to the adverse reactions so that the patient can tolerate the treatment. Adverse reactions caused by this product can be treated by symptomatic treatment, suspension of medication and/or dose adjustment. According to the degree of adverse reactions, it is recommended to adjust the dose under the guidance of a physician: ① The first dose adjustment: 10 mg, once a day, for 2 consecutive weeks, and then stop for 1 week; ② The second dose adjustment: 8 mg, once a day, for 2 consecutive weeks, and then stop for 1 week (for the dose adjustment method, please refer to Tables 1~2 and [Precautions]). If the 8 mg dose is still not tolerated, the drug should be permanently discontinued. When non-hemorrhagic adverse reactions occur, the dose should first be adjusted according to the general principles of Table 1. When bleeding adverse reactions occur, the dose should be adjusted according to Table 2.

This manual describes the adverse reactions observed in clinical trials that are judged to be possibly caused by anlotinib and their incidence rates. Adverse reactions include adverse events that are judged by researchers to be definitely related, probably related, possibly related, possibly unrelated, and undetermined to anlotinib. Since clinical trials are not conducted under the same conditions, the incidence of adverse reactions observed in one clinical trial should not be directly compared with the incidence of adverse reactions observed in other clinical trials, and may not accurately predict the actual incidence in clinical practice.