Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 7 BLISTER @ 4 KAPSUL
2022-06-04
TASIGNA ® (NILOTINIB) 200 mg hard capsules LEAFLET DISETUJUI OLEH BPOM: 22/03/2021 ID: EREG10000512000230 TRADENAME 200 MG HARD CAPSULES TASIGNA ® 200 mg hard capsules DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Hard capsules 200 MG HARD CAPSULES White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “NVR/TKI”. ACTIVE SUBSTANCE 200 MG HARD CAPSULES Each capsule contains 200 mg nilotinib base (as hydrochloride, monohydrate). EXCIPIENTS 200 MG HARD CAPSULES Capsule content: Lactose monohydrate; Crospovidone; Poloxamer 188; Silica colloidal, anhydrous/Colloidal silicon dioxide; Magnesium stearate. Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, yellow (E 172). Printing ink: Iron oxide, red (E 172). INDICATIONS TASIGNA hard capsule is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant to at least one prior therapy including imatinib. Ph+ CML patients in chronic phase, who have been previously treated with imatinib and whose treatment has been switched to TASIGNA for at least 3 years and have achieved a sustained deep molecular response may be eligible for treatment discontinuation (see sections Dosage regimen and administration and Clinical studies). DOSAGE REGIMEN AND ADMINISTRATION Therapy with TASIGNA should be initiated by a physician experienced in the treatment of patients with CML. DISETUJUI OLEH BPOM: 22/03/2021 ID: EREG10000512000230 TASIGNA may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated. TASIGNA may be given with hydroxyurea or anagrelide if clinically indicated. Monitoring of response to Tasigna therapy in Ph+ CML patients should be performed both routinely and when therapy is modified, to identify suboptimal response, loss of response to therapy, poor patient compliance, or possible drug-d Baca dokumen lengkap