Gleevec capsules 100 mg 120 pcs
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Description
Glivec capsules - a Swiss drug used in the treatment of tumor processes. The active ingredient imatinib blocks enzymatic processes at the level of growth and development of cancer cells. Thus, the process of self-destruction of a malignant neoplasm is included.
Active ingredients
Imatinib
Release form
Capsules
Composition
Imatinib mesilate, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, yellow iron oxide dye, red iron oxide dye. Ink: dye iron oxide red (E172), shellac, soy lecithin.
Pharmacological effect
Imatinib has a selective inhibitory effect on the Bcr-Abl-tyrosine kinase enzyme, which is formed by the fusion of a portion of the Bcr gene (breakpoint center region) and the Abl (Abelson) proto-oncogene, at the cellular level, selectively suppresses proliferation and causes apoptosis of cell lines expressing Bcr-Abl-tyrosine-tyrosine-tyrosine-tyrosine-tyrosine expressing cell proliferation. , including immature leukemic cells, which are formed in patients with positive, but Philadelphian chromosome, chronic myeloid leukemia and acute lymphoblastic leukemia. Imatinib selectively inhibits Vg-Abl-positive colonies obtained from the blood cells of patients with chronic myeloid leukemia. Imatinib inhibits proliferation and induces apoptosis of stromal tumor cells of the gastrointestinal tract expressing a tyrosine kinase with a mutation of the c-Kit receptor.
Pharmacokinetics
Bioavailability of the drug is on average 98%. When taking the drug with a diet high in fat compared to fasting, there is a slight decrease in the degree of absorption (decrease in Cmax of imatinib in blood plasma by 11%, AUC - by 7.4%) and a slowdown in the rate of absorption (increase in Tmax of imatinib in blood plasma 1.5 h) Imatinib binding to plasma proteins is about 95% (mainly with albumin and acid α-glycoproteins, to a small extent with lipoproteins). After taking a single dose, the drug is excreted from the body within 7 days, mainly in the form of metabolites (68% with feces and 13% with urine). About 25% of the dose is excreted unchanged (20% with feces and 5% with urine). T1 / 2 imatinib is about 18 hours.
Indications
Philadelphia chromosome (Ph +) positive chronic myeloid leukemia (CML), first detected in children and adults,Ph + CML in the chronic phase in case of failure of previous interferon alpha therapy or in the acceleration phase or blast crisis in children and adults, first diagnosed positive for Philadelphia chromosome (Ph +) acute lymphoblastic leukemia (ALL) in adult patients in combination with chemotherapy, recurrent or refractory Ph + ALL in adult patients as monotherapy, Myelodysplastic / myeloproliferative diseases associated with gene rearrangements of platelet growth factor receptor, in adult patients, Syst Multiple mastocytosis in adult patients with no D816V c-Kit mutation or with unknown c-Kit mutational status, Hyper-eosinophilic syndrome and / or chronic eosinophilic leukemia in adults with positive or negative abnormal FIP1L1-PDGRF alpha tyrosine kinase, Inoperable reason and / or metastasis, and I-metastasis; c-Kit positive stromal tumors (CD 117) in adult patients, Adjuvant therapy of c-Kit positive gastrointestinal stromal tumors (CD 117) in adult patients, Inoperable, recurrent and / and whether metastatic bulging dermatofibrosarcoma in adult patients.
Contraindications
Hypersensitivity to the drug.
Precautionary measures
Caution should be given to Hlivec patients with severe hepatic insufficiency, severe renal impairment, cardiovascular diseases or in the presence of risk factors for heart failure, as well as during regular hemodialysis.
Use during pregnancy and lactation
Contraindicated
Dosage and administration
The drug should be taken with meals with a full glass of water to reduce the risk of gastrointestinal disorders. Patients who do not have the ability to swallow the capsule whole, the drug can be taken in diluted form. The contents of the capsules are placed in a glass, filled with water or apple juice (50 ml of liquid for pills of 100 mg and 100 ml for pills of 400 mg), stirred, the resulting suspension should be taken orally immediately after preparation. The dose and period of therapy are determined by the doctor on the basis of clinical indications . Doses of 400 mg and 600 mg / day should be taken in 1 reception, the daily dose of 800 mg should be divided into 2 doses - 400 mg in the morning and evening.
Side effects
Neutropenia, thrombocytopenia, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, diarrhea, myalgia, muscle cramps, rash, weakness, abdominal pain.
Overdose
Symptoms: nausea, vomiting, diarrhea, rash, erythema, edema, swelling (mostly persons), fatigue, muscle spasms, thrombocytopenia, pancytopenia, gastrointestinal pain, headache, loss of appetite, Treatment: recommended medical observation and symptomatic therapy . The antidote to Gleevec is unknown.
Interaction with other drugs
With simultaneous use of Glivec with drugs inhibiting CYP3A4 isoenzyme (including ketoconazole, itraconazole, erythromycin, clarithromycin), imatinib metabolism may be slowed down and its plasma concentration will increase. On the contrary, the simultaneous use of drugs which are inducers isoenzyme CYP3A4 (e.g., dexamethasone, phenytoin, fosphenytoin, rifampin, phenobarbital or preparations Hypericum perforatum, carbamazepine, oxcarbazepine, primidone), may lead to increased imatinib metabolism and reduce its concentration in the simultaneous application plazme.Pri Imatinib and simvastatin showed an increase in Cmax and AUC of simvastatin by 2 and 3.5 times, respectively, which is a consequence of inhibition of the CYP3A4 isoenzyme with imatinib.
special instructions
When handling the drug, avoid contact with the skin and eyes, as well as inhalation of the drug powder. Treatment with Gleevec should be carried out only under the supervision of a physician with experience in working with anticancer drugs. When applying Glivec, it is recommended to conduct regular clinical studies of peripheral blood and monitoring liver function (transaminases, bilirubin, alkaline phosphatase). Care should be taken to monitor patients with heart disease.
Storage conditions
At a temperature not higher than 30 ° C.
Keep out of the reach of children.