Drug Information: Indications, Side Effects, Warnings
Category: Â Cancer
Generic Gleevec interferes with the growth of some cancer cells; is used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer, or certain tumors of the stomach and digestive system.
If you want to buy Generic Gleevec (Imatinib), contact your doctor for a prescription. You can buy Generic Gleevec online. Use coupon or discount card — buy Generic Gleevec cheaper!
Antineoplastic agent — a protein tyrosine kinase inhibitor [Antineoplastic — protein kinase inhibitors]
Nosological classification (ICD-10):
C26 Malignant neoplasm of other and ill-defined digestive organs
C44.9 Malignant neoplasm of skin of unspecified region
C78.8 Secondary malignant neoplasm of other and unspecified digestive organs
C79.2 Secondary malignant neoplasm of skin
C91 Lymphoid leukemia [lymphocytic leukemia]
C91.0 Acute lymphoblastic leukemia
C92.1 Chronic myeloid leukemia
C96.2 Malignant mast cell tumor
D46 Myelodysplastic Syndromes
D47.1 Chronic myeloproliferative disease
Capsules 100 mg, 1 capsule Active ingredient: 50 mg of imatinib; 100 mg
(corresponding to 119.50 mg or 59.75 mg of imatinib mesylate)
Excipients: MCC — 46 mg / 92 mg; crospovidone 7.5 mg / 15 mg; Colloidal silicon dioxide 1 mg / 2 mg; Magnesium stearate 0 75 mg / 1.5 mg; titanium dioxide 0.38 mg / 0.6 mg; gelatin 47.51 mg / 74.81 mg; dye yellow iron oxide 0.11 mg / 0.03 mg; iron oxide red dye (for caps. 100 mg) — 0.56 mg
The composition of the ink: dye iron oxide red (E172); shellac; soy lecithin
Description of the dosage form:
Capsules, 50 mg: opaque, size â„–3, light yellow or orange-yellow, marked Â«NVR SHÂ» red ink.
Capsules 100 mg: opaque, size â„–1, orange or orange with a grayish tint, labeled Â«NVR SIÂ» red ink.
Contents of capsules: powder white and yellow.
Characteristics of the product:
Anticancer agent, an inhibitor of protein tyrosine kinase.
— Imatinib has a selective inhibitory effect on the enzyme Vcr-Abl-tyrosine
— This enzyme forming the fusion gene region Bcr (breakpoint cluster region) and proto-Abl (Abelson)
— Effect on the cellular level is
— The drug selectively inhibits proliferation and induces apoptosis in cell lines expressing Vcr-Abl-tyrosine (including immature leukemic cells)
— Imatinib selectively inhibits WASH-Abl-positive colonies (derived from blood cells of patients with chronic myeloid leukemia)
— Imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumor (expressing a mutant tyrosine kinase c-Kit receptor).
After oral administration, the bioavailability of the drug is 98% on average. The coefficient of variation for the index AUC is 40-60%.
Distribution of matter:
About 95% of the imatinib binds to plasma proteins (mainly — with albumin and alpha-acid glycoprotein, to a minor extent — lipoproteins).
Metabolism: Imatinib is metabolized primarily in the liver (with the formation of the main metabolite (N-demethylated derivative piperazinovooe) circulating in the bloodstream).
Indications for use:
— Newly diagnosed Philadelphia chromosome positive (Ph +) chronic myeloid leukemia (CML) in children and adults;
— Use at: Ph + CML in chronic phase at the failure of previous treatment with interferon alpha or in accelerated phase or blast crisis in children and adults;
— When newly diagnosed Philadelphia chromosome positive (Ph +) acute lymphoblastic leukemia (ALL) in adults in combination with chemotherapy;
— If the patient has relapsed or refractory Ph + ALL in adult patients as monotherapy;
— Used for the treatment of myelodysplastic / myeloproliferative diseases associated with gene rearrangement platelet-derived growth factor receptor, in adults;
— Drug affects systemic mastocytosis adult patients with no c-Kit D816V mutation of unknown or c-Kit mutation status;
— Hypereosinophilic syndrome and / or chronic eosinophilic leukemia in adults with a positive or negative abnormal FIP1L1-PDGRF alpha tyrosine kinase;
— Used for unresectable and / or metastatic malignant gastrointestinal stromal tumors positive for c-Kit (CD 117) adult patients;
— Adjuvant treatment of gastrointestinal stromal tumors positive for c-Kit (CD 117) in adult patients;
— Patient has inoperable, recurrent and / or metastatic dermatofibrosarcoma protuberans in adult patients.
— Tell your doctor if you have hypersensitivity to imatinib and other ingredients;
— You should not take the medication during lactation (breastfeeding);
— Children under 2 years of age (efficacy and safety has not yet been established).
With careful preparation can be appointed to persons:
— Patients with severe hepatic impairment, severe renal impairment. The physician should to adjust the dose.
— In patients with cardiovascular disease.
— In the presence of risk factors for heart failure
— During regular hemodialysis.
If you have one of these diseases before taking this medication should always consult with a physician.
Neutropenia, thrombocytopenia, anemia, headache, indigestion, swelling, weight gain, nausea, vomiting, diarrhea, myalgia, muscle cramps, rash, weakness, pain in the abdomen. Most of these adverse events were mild or moderate.
Infectious and parasitic diseases: rarely occurs herpes simplex, herpes zoster, nasopharyngitis, pnevmoniya1, sinusitis, an inflammation of the subcutaneous tissue, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, septicemia; rare — the patient gets mycoses.
Sometimes it: benign, malignant and unspecified neoplasms (including cysts and polyps): rarely — tumor lysis syndrome.
The drug causes blood disorders and lymphatic system: very often — neutropenia, thrombocytopenia, and anemia; often — pancytopenia, febrile neutropenia; infrequently — thrombocythemia, lymphopenia, inhibition of bone marrow hematopoiesis, eosinophilia, lymphadenopathy; rarely — hemolytic anemia. Tell your doctor about side effects.
Violations by metabolism and nutrition: often — anorexia; rarely — hypokalemia, increased or decreased appetite, hypophosphataemia, dehydration, hyperuricemia, gout, hypercalcemia, hyperglycemia, hyponatremia; rarely — hyperkalemia, hypomagnesemia. Dosage is adjustment.
The drug can cause mental disorders: often — insomnia; rarely — depression, anxiety, decreased libido; rarely — confusion.
Disorders of the nervous system: very often — headache; often — dizziness, paresthesia, taste disturbance, hypoesthesia. Infrequently, patients talk about migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, hemorrhagic stroke; rarely — increased intracranial pressure, convulsions, optic neuritis.
Sometimes the drug causes Violations of the organ of vision: often — swelling of the eyelids, increased lacrimation, conjunctival haemorrhage, conjunctivitis, dry eye syndrome, blurred (blurred vision); infrequently — eye irritation, eye pain, orbital edema, hemorrhage in the sclera of the eye, retinal hemorrhage, blepharitis, macular edema; rarely — cataract, papilledema, glaucoma.
There were cases Violations by the organ of hearing and labyrinth disorders: rarely — vertigo, tinnitus, hearing loss.
Heart problems: Infrequent — palpitations, hronicheskaya3 heart failure, pulmonary edema, tachycardia, prilivy4; rarely — arrhythmias, atrial fibrillation, sudden cardiac arrest; myocardial infarction, angina pectoris, pericardial effusion, increased blood pressure, hematoma.
Irregularities were detected by the vessels: rare — bleeding; rarely — bruising, cold extremities, lower blood pressure, Raynaud’s syndrome.
Irregularities were detected by the respiratory system of the chest, mediastinum: often — nosebleeds, shortness of breath, cough; infrequently — pleural vypot5, pain in the throat or larynx, throat; rarely — pleuritic chest pain, pulmonary fibrosis, pulmonary hypertension, pulmonary hemorrhage.
More often than not there is a violation of the digestive system: very often — nausea, vomiting, diarrhea, indigestion, pain in zhivote6; often — bloating, flatulence, constipation, gastroesophageal reflux disease, xerostomia, gastritis; rarely patients have stomatitis, ulceration of the mucous membranes of the mouth, gastrointestinal bleeding, belching, melena, esophagitis, ascites, gastric ulcer, vomiting blood, cheilitis, dysphagia, pancreatitis; rarely — colitis, paralytic / obstructive ileus, intestinal inflammation.
There are cases of violations of the liver and biliary tract: often elevated liver enzymes, rarely — jaundice, hepatitis, hyperbilirubinemia, rarely — liver failure, necrosis pecheni9.
Patients have Dermatological reactions, such as: — swelling, dermatitis, eczema, skin rash; often — swelling of the face, itching, dry skin, erythema, alopecia, night sweats, photosensitivity reactions; infrequently — pustular rash, petechiae, increased sweating, rash, ecchymosis, increased susceptibility to bruise, hypotrichosis, hyperpigmentation / hypopigmentation of the skin, exfoliative dermatitis, nail damage, folliculitis, petechiae, psoriasis, purpura, bullous eruption; rarely — acute febrile neutrophilic dermatosis (Sweet’s syndrome), discoloration of nails, angioedema, erythema multiforme, leykoplastichesky vasculitis, Stevens-Johnson syndrome, acute generalized pustular rash.
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