Trade name : Glivec
Active component : Glivec 400mg
Strength : Imatinib
Manufactured by : Novartis India Ltd
Pack : 28 tablets in a container
Glivec 400mg is a antineoplastic agents and used by alone regimen or together with other medicines for the treatment of different types of cancer or bone marrow conditions, the main ingredient which is used as imatinib . Glivec 400mg will prevents the development of cancer cells in the body.
Chronic myeloid leukaemia
• Chronic phase:
The patients with Chronic phase the drug administrated 400 mg per day, given up to 600 mg/day or 400 mg bid if needed. The patients with Blast crisis or accelerated phase administrated 600 mg per day, up to 400 mg bid if required. Acute lymphoblastic leukaemia :Dose of 600 mg per day with induction, consolidation or maintenance therapy ; Monotherapy in relapsed or refractory acute lymphoblastic leukaemia 400 mg per day up to 400 mg bid is administrated for Unresectable, metastatic GI stromal tumours 400 mg/day. starting with100 mg/day in patients w/ith FIP1L1-PDGF-α fusion kinase is given for Hypereosinophilic syndrome Myelodysplastic disease: 400 mg per day. Mastocytosis 400 mg per day. starting with100 mg/day if there is analog eosinophilia. Dermatofibrosarcoma protuberans: 400 mg bid. Glivec 400mg should administer with food through oral route.
MECHANISM OF ACTION
Imatinib is a protein-tyrosine kinase inhibitor which inhibits the Bcr-Abl tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in chronic myeloid leukemia (CML).
Glivec 400mg is a group of anti cancer drug which prevents the development of cancer cells and bone marrow condition. Glivec 400mg is also known as tyrosine kinase inhibitor which interferes with the BCR-ABL tyrosine kinase produced by the Philadelphia chromosome abnormality in chronic myeloid (blood cancer) leukaemia(CML). It stops the multiplication and induces suppress in BCR-ABL positive cell lines, thereby leukaemic cells from Philadelphia chromosome positive CML. The drug which also prohibits the receptor kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-kit, PDGF- and SCF-mediated cellular effects..
rapid and complete absorbed from the GI tract. Bioavailability of Glivec 400mg is Approx 98%. Duration of peak plasma concentration: 2-4 hr.
The bounding of human serum protein of Glivec 400mg is Approx 95%.
Glivec 400mg metabolized in CYP3A4 isoenzyme and to a lesser extent through CYP1A2, CYP2D6, CYP2C9 and CYP2C19 isoenzymes.active metabolite of Glivec 400mg is N-demethylated piperazine derivative.
excreted via faeces (68%) and urine (13%) within 7 days; excreted mainly as metabolites, with 25% as unchanged drug. The half-life: 18 hr Glivec 400mg and approx 40 hr (N-demethylated piperazine derivative).
BEFORE USE OF GLIVEC 400MG
CARE TO BE TAKEN
Inform your doctor about previously taking medicine involved in prescription and non prescription, over the counter, vitamins, herbal, nutritional supplements before taking treatment with drug Glivec 400mg Do not consume the aspirin, or products containing aspirin until doctor specifically permit may decrease the effectiveness of this medication. Acetominophen (Tylenol®) may not be recommended. Inform your doctor Before starting this treatment.discuss with health care professional if you are pregnant or chance of to be pregnant Both of the men and women: avoid conceive a child (get pregnant) while on treatment with Glivec 400mg. Impediment way of contraception, such as condoms, are recommended. Inform the consultants , it will be safe to become pregnant or conceive a child after treatment. Avoid breast feed while on medication therapy.
Glivec 400mg+ CYP3A4 inhibitor( azole antifungal, macrolide) → increased serum levels
Glivec 400mg + CYP3A4 inducers → reduced serum concentration
Food interaction: with grape fruit Glivec 400mg reduce serum levels.
Hypersensitivity and lactation contraindicated with Glivec 400mg
if a single dose is missed, have the drug probably soon Next dose time reaches then leave the missed dose and continue the regular schedule Please consult with the doctor.
Glivec 400mg store below 30℃. Place the drug in tight container, protected from sunlight, moisture and freezing Keep out of the children’s Discard the drug after the expiry date. Dispose the unused drug by asking to the Pharmacist.
Some Glivec 400mg side effects of occurring in >30% for patients :
Low RBC,WBC and platelets: May increased risk for infection, anemia or bleeding; Nausea and vomiting; Swelling of the face, feet, hands (edema) ; Muscle cramps and bone pain; Diarrhea; bleeding problem; Skin rash; Fever.
Less common side effects of Glivec 400mg :
Dyspnea; fatigue; athralagia; stomach cramping; heartburn; cold; decreased appetite; constipation, night sweat; weakness; problems in fertility.