Mabic-20 - Tablet Dasatinib - 20mg 1 Tablet(s) / Tablet Genvio Pharma Ltd. Introduction: Mabic-20 is used in the treatment of blood cancer (chronic myeloid leukaemia). It is used in patients whose disease could not be treated with other medications for leukaemia or who cannot take these medications because of side effects. Mabic-20 can be taken with or without food, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly... Uses of Mabic-20: Blood cancer (Chronic myeloid leukaemia) Side effects of Mabic-20: Abdominal painAnemia (low number of red blood cells)Breathing problemsFatigueFeverHeadacheInfectionLow blood plateletsMusculoskeletal (bone, muscle or joint) painNauseaRashVomiting How to use Mabic-20: 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. Mabic-20 may be taken with or without food, but it is better to take it at a fixed time. How Mabic-20 works: Mabic-20 is an anti-cancer medication. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. What if you forget to take Mabic-20?: If you miss a dose of Mabic-20, skip it and continue with your normal schedule. Do not double the dose. Indication: Chronic myeloid leukaemia Administration: May be taken with or without food. Swallow whole, do not break/crush/cut. Adult Dose: Oral Chronic myeloid leukaemia Adult: Chronic phase CML: Initially, 100 mg once daily, may increase up to 140 mg once daily. Accelerated, myeloid or lymphoid blast phase CML or Philadelphia chromosome-positive ALL: Initially, 140 mg once daily, may increase up to 180 mg once daily. Hepatic impairment: No dosage adjustment needed. Contraindication: Concomitant use w/ CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole or grapefruit juice); CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampicin or St John's wort); antacid. Pregnancy. Mode of Action: Dasatinib is an inhibitor of multiple tyrosine kinases. It is used for the treatment of all phases of chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukaemia (ALL) in adults who have resistance or intolerance to previous therapy, including imatinib. Precaution: Patients w/ predisposing factors for QT prolongation (e.g. congenital long QT syndrome, hypokalaemia, hypomagnesaemia, on antiarrhythmic therapy, or receiving cumulative high doses of anthracyclines). Hepatic impairment. Lactation. Monitoring Parameters Evaluate patients for manifestations of underlying cardiopulmonary disease prior to and during therapy. Measure full blood counts wkly for the 1st 2 mth and then mthly thereafter. Lactation: not known if excreted in breast milk; do not nurse Side Effect: >10% Fluid retention, incl CHF, pulm edema, pleural effusion (50%),Diarrhea (49%),Headache (40%),Hemorrhage (40%),Fatigue (39%),Pyrexia (39%),Skin rash (35%),Infection (34%),Nausea (34%),Dyspnea (32%),Cough (28%),Pain (26%),Abdominal pain (25%),Vomiting (22%),Anorexia (19%),Arthralgia (19%),Asthenia (19%),Constipation (14%),Dizziness (14%),Musculoskeletal pain (14%),Weight loss (14%),Chest pain (13%),Neuropathy (13%),Myalgia (12%),Abdominal distention (11%),Arrhythmia (11%),Chills (11%),Pneumonia (11%),Pruritus (11%),Weight gain (11%) 1-10% (selected) Anemia,Febrile neutropenia,Thrombocytopenia,Mucosal inflammation Vascular disorders: Thrombosis/embolism (including pulmonary embolism, deep vein thrombosis) Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, pulmonary arterial hypertension Dermatologic reactions: Stevens-Johnson syndrome, erythema multiforme Pregnancy Category Note: Pregnancy Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman; adverse pharmacologic effects (eg, hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia) have been reported with maternal exposure to dasatinib Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates; skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses; these findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib Advise a pregnant woman of the potential risk to a fetus Transplacental transfer of dasatinib has been... Interaction: Concomitant use w/ drugs that have narrow therapeutic index (e.g. alfentanil, cisapride, ciclosporin, fentanyl, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, ergot alkaloids) as it may increase the serum levels of these drugs. Increased risk of bleeding and thrombocytopenia w/ antiplatelet drugs, anticoagulants, and NSAIDs. Potentially Fatal: May reduce plasma levels w/ antacids, administer antacid 2 hr apart from the admin of dasatinib. May increase plasma levels w/ CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole). May reduce plasma levels w/ CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital or rifampicin).