Dasatinib

【Product name】Sprycel

[English common name]Dasatinib

[Chinese common name]Dasatinib

[English name]Intermediate

[Chinese other name]Dasatinib intermediate

[Indications] This product is suitable for drug resistance or intolerance to treatment regimens including imatinib mesylate.Chronic myeloid leukemia(CML) Adult patients with all stages (chronic, accelerated, lymphocytic, and myelocyte blast). In addition, this product can be used for Philadelphia chromosome-positive acute lymphocytes that are resistant or intolerant to previous treatments. Adult leukemia (Ph+All) adult patients.

[Usage and Dosage] should be treated by a physician with experience in the diagnosis and treatment of leukemia.
Patients with Ph+ chronic CML are recommended to have a starting dose of dasatinib 100 mg once daily for oral administration. The time of administration should be the same, either in the morning or at night.
In patients with CML during the Ph+ acceleration period and the blast phase (acute granules and acute leaching), the recommended starting dose is 70 mg twice daily, which is taken orally in the morning and evening (see [Precautions]).
Tablets must not be crushed or cut and must be swallowed whole. This product can be taken with food or on an empty stomach.
Duration of treatment: In clinical trials, the treatment of this product continues until the disease progresses or the patient no longer tolerates the treatment. The effects of discontinuation of treatment on chronic disease outcomes have not been studied after achieving cytogenetic or molecular remission [including complete cytogenetic remission (CCyR), major molecular remission (MMR), and MR4.5].
In order to achieve the recommended dosage, the product has four specifications of 20mg, 50mg, 70mg and 100mg film tablets. It is recommended to increase or decrease the dose depending on the patient's response and tolerability.
Dose escalation: In clinical trials of adult Ph+ CML patients, if the patient fails to achieve hematologic or cytogenetic remission at the recommended initial dose, patients with chronic CML can increase the dose to 140 mg once daily. For patients with CML in the advanced phase (accelerated phase and blast phase), the dose can be increased to 90 mg twice daily.

[Storage]Store below 30 °C.

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