Tyrokin 400mg 10pcs(Box)

INDICATIONS: TYROKIN is indicated for the

• Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML).

• Treatment of adult and paediatric patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

• Treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

• Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.

• Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

• Treatment of adult patients with systemic mastocytosis (SM) without the D816V c-KIT mutation or with c-Kit mutational status unknown.

• Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).

• Treatment of adult patients with KIT+ (CD117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

• Adjuvant treatment of adult patients following resection of KIT+GIST.

• Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

DOSAGE AND ADMINISTRATION: The prescribed dose should be administered orally with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening. For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).

Dosage in CML The recommended dosage of TYROKIN is 400 mg/day for patients in chronic phase CML and 600 mg/day for patients in accelerated phase or blast crisis. Dose increase from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg daily in patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia.

Dosage in Ph+ ALL The recommended dose of TYROKIN is 600 mg/day for patients with Ph+ ALL. Dosage in MDS/MPD The recommended dose of TYROKIN is 400 mg/day for patients with MDS/MPD.

Dosage in SM The recommended dose of TYROKIN is 400 mg/day for patients with SM without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with TYROKIN at dose of 400 mg/day may be considered for patients with SM not responding satisfactorily to other therapies. For patients with SM associated with eosinophilia, a clonal haematological disease related to the fusion kinase FIP1L1-PDGFR-alpha, a starting dose of 100 mg/day is recommended.

Dosage in HES/CEL The recommended dose of TYROKIN is 400 mg/day for patients with HES/CEL. For HES/CEL patients with demonstrated FIP1L1-PDGFR-alpha fusion kinase, a starting dose of 100 mg/day is recommended. A dose increase from 100 mg to 400 mg for these patients may be considered.

Dosage in GIST The recommended dose of TYROKIN is 400 mg/day for patients with unresectable and/or metastatic, malignant GIST. A dose increase from 400 mg to 600 mg or 800 mg for patients may be considered. 

Dosage in DFSP The recommended dose of TYROKIN is 800 mg/day for patients with DFSP

PRECAUTIONS: When TYROKIN is co-administered with other medications, there is a potential for drug interactions. Caution should be used when taking TYROKIN with rifampicin or other strong CYP3A4 inducers, ketoconazole or other strong CYP3A4 inhibitors, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide) or CYP2C9 substrates with a narrow therapeutic window (e.g. warfarin and other coumarin derivatives).