ibakin 400 - Tablet Imatinib - 400mg 1 Tablet(s) / Tablet Genvio Pharma Ltd. Introduction: ibakin 400 belongs to the class of medicines known as tyrosine kinase inhibitors. It is used in the treatment of blood cancer (chronic myeloid leukaemia and Acute lymphocytic leukemia) and gastrointestinal stromal tumor. ibakin 400 should be taken with food, but better to have it same time every day to get the most benefit. You should continue to take it as long as your doctor advises for it. The duration of treatment varies according to your need and response to treatment. Taking it in the wrong way or taking too much can cause very serious side effects. It may take... Uses of ibakin 400: Blood cancer (Chronic myeloid leukaemia)Blood cancer (Acute lymphocytic leukemia)Gastrointestinal stromal tumour Side effects of ibakin 400: Abdominal painDiarrheaFatigueMuscle crampMusculoskeletal (bone, muscle or joint) painNauseaRashVomiting How to use ibakin 400: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. ibakin 400 is to be taken with food. How ibakin 400 works: ibakin 400 is an anti-cancer medication. A protein enzyme, bcr-abl tyrosine kinase, responsible for the growth of abnormal proliferation of cancer cells. This medicine inhibits the proliferation and induces apoptosis (planned cell death) in bcr-abl positive cells (cancer cells). This is how it works to stop or slow the spread of cancer. What if you forget to take ibakin 400?: If you miss a dose of ibakin 400, skip it and continue with your normal schedule. Do not double the dose. Indication: Chronic myeloid leukaemia, Acute lymphoblastic leukaemia, Myelodysplastic disease, Hypereosinophilic syndrome, Mastocytosis, Dermatofibrosarcoma protuberans, Malignant gastrointestinal stromal tumours Administration: Should be taken with food and large glass of water. Adult Dose: Acute Lymphoblastic Leukemia Indicated for adults with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) 600 mg PO qDay Myelodysplastic/Myeloproliferative Diseases Indicated in adults with myelodysplastic/ myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements as determined with an FDA-approved test 400 mg PO qDay Hypereosinophilic Syndrome/Eosinophilic Leukemia Indicated for adults with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR-alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR-alpha fusion kinase negative or unknown 400 mg PO qDay In patients with demonstrated... Child Dose: Chronic Myeloid Leukemia Indicated for newly diagnosed adult and pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase 1 year: 340 mg/m²/day PO; not to exceed 600 mg/day Acute Lymphoblastic Leukemia Indicated for treatment of newly diagnosed children with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) 1 year: 340 mg/m²/day PO; not to exceed 600 mg/day Contraindication: Hypersensitivity. Lactation. Mode of Action: Imatinib, is a tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase created by the Philadelphia chromosome abnormality in chronic myeloid leukaemia (CML). It blocks proliferation and induces apoptosis in BCR-ABL positive cell lines, as well as fresh leukaemic cells from Philadelphia chromosome positive CML. Imatinib also inhibits receptor kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-kit, PDGF- and SCF-mediated cellular events. Precaution: Cardiac disease or increased risk for CHF. Monitor for signs of severe fluid retention. Monitor CBC regularly. Renal and hepatic impairment. Monitor LFTs. Pregnancy. Lactation: Imatinib and its active metabolite are excreted into human milk; advise a lactating woman not to breastfeed during treatment and for 1 month after last dose Side Effect: >10% Edema (53%),Neutropenia (Grade 3: 7-27%; Grade 4: 3-48%),Nausea (43%),Muscle cramps (35%),Musculoskeletal pain (34%),Thrombocytopenia (Grade 3: 1-31%; Grade 4: 1-34%),Rash (32%),Fatigue (31%),Diarrhea (30%),Headache (29%),Arthralgia (27%),Abd pain (23%),Myalgia (21%),Nasopharyngitis (19%),Hemorrhage (19%),Vomiting (15%),Dyspepsia (15%),Cough (13%),Dizziness (13%),URT infection (13%),Fever (12%),Weight gain (12%),Hepatotoxicity (6-12%),Insomnia (11%) 1-10% Flushing,Palpitation,Dry skin,Erythema,Metabolic hyperglycemia,Stomatitis/mucositis,Lymphopenia <1% Aplastic anemia,Atrial fibrillation,Avascular necrosis,Cardiac failure,Cardiogenic shock,Embolism,Eosinophilia Potentially Fatal: Hepatotoxicity, cerebral oedema, increased intracranial pressure, papilloedema. Severe fluid retention resulting in pleural and pericardial effusion, pulmonary oedema and ascites. Rarely, GI perforation. Interaction: Increased serum levels w/ CYP3A4 inhibitors (e.g. azole antifungals, macrolide antibiotics). Reduced serum levels w/ CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin). May increase serum levels of substrates of CYP3A4 (e.g. ciclosporin, pimozide, triazolo-benzodiazepines, dihydropyridine Ca channel blockers, certain statins), CYP2C9 (e.g. warfarin) and CYP2D6.