Imarem 400mg film-coated tablets

Manufacturer
Remedica Ltd.(CYPRUS)

Registraction Number
MAL20016151AZ

Content:
Imarem 400mg Film-Coated Tablets contain the active ingredient imatinib mesylate. Each tablet contains 400 mg of imatinib mesylate.
Indications:
Imarem is used for the treatment of:
-Chronic Myeloid Leukemia (CML): In adult and pediatric patients with newly diagnosed CML, as well as those in blast crisis, accelerated phase, or chronic phase after failure of interferon-alpha therapy.
-Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL): In adult and pediatric patients, integrated with chemotherapy.
-Myelodysplastic/Myeloproliferative Diseases (MDS/MPD): In adult patients associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
-Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL): In adult patients with FIP1L1-PDGFRα re-arrangement.
-Dermatofibrosarcoma Protuberans (DFSP): In adult patients with unresectable, recurrent, and/or metastatic DFSP.
-Aggressive Systemic Mastocytosis (ASM): In adult patients without the D816V c-Kit mutation or with c-Kit mutational status unknown.
Instructions:
Dosage:
CML or GIST: The usual starting dose is 400 mg once daily or 600 mg once daily.
Ph+ ALL: The starting dose is 600 mg once daily.
MDS/MPD: The starting dose is 400 mg once daily.
HES/CEL: The starting dose is 100 mg once daily, which may be increased to 400 mg once daily.
DFSP: The starting dose is 800 mg once daily.
ASM: The starting dose is 400 mg once daily.
Administration:
Take the tablet with a full glass of water.
It can be taken with or without food.
Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take extra medicine to make up the missed dose