Gleevec is an anti-tumor drug.
Release form and composition
Gleevec is available in the form of capsules and coated tablets, the main active ingredient of which is imatinib.
As excipients in the preparation used:
- Capsules - crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, dyes: yellow oxide and red;
- Tablets - microcrystalline cellulose, hypromellose, crospovidone, colloidal silicon dioxide, magnesium stearate, yellow iron oxide, talc, macrogol 4000, red iron oxide.
Capsules are available in 50 and 100 mg in blisters of 24, 30, 36, 48, 96, 120 and 210 pieces per pack; tablets - 100 and 400 mg in blisters of 10, 20, 30 and 60 pieces per pack.
Indications for use
According to the instructions, Gleevec is used when:
- Philadelphia chromosome-positive acute lymphoblastic leukemia was diagnosed for the first time simultaneously with chemotherapy in adult patients;
- Newly identified chronic myeloid leukemia positive for Philadelphia chromosome in adults and children;
- The chronic phase of chronic myeloid leukemia positive for Philadelphia chromosome after unsuccessful interferon alpha therapy, or in the blast crisis phase or acceleration in adults and children;
- Refractory or recurrent acute lymphoblastic leukemia positive for Philadelphia chromosome as monotherapy in adult patients;
- Systemic mastocytosis in adult patients;
Also Gleevec is shown when:
- Inoperable, recurrent or metastatic bulging dermatofibrosarcoma in adults;
- Myelodysplastic or myeloproliferative diseases in adulthood;
- Inoperable or metastatic malignant c-KIT positive (CD 117) gastrointestinal stromal tumors in adulthood;
- Hypereosinophilic syndrome or chronic eosinophilic leukemia in adulthood;
- Conducting adjuvant therapy for c-KIT positive (CD 117) gastrointestinal stromal tumors in adulthood.
According to the instructions, Gleevec is contraindicated for use:
- During pregnancy and breastfeeding;
- At the age of 2 years;
- If the patient has individual intolerance to the components of the drug.
According to the instructions, Gleevec cautiously used:
- In patients with severe disorders of the kidneys and liver;
- In case of cardiovascular diseases or the patient has risk factors for the development of heart failure;
- During the hemodialysis procedure.
Dosing and Administration
According to the instructions, Gleevec capsules and tablets for oral administration. It is taken during a meal with a glass of water.
When applying Glivec in childhood or when it is impossible to swallow a capsule or tablet, the entire contents of the capsule can be diluted with apple juice or water, and the tablets can be crushed and diluted.
- In chronic myeloid leukemia in the chronic phase - 400 mg per day once; with blastic crisis and in the acceleration phase - 600 mg per day once; children - 340 mg per square meter of body surface per day, while the daily dose should not be more than 600 mg;
- In acute lymphoblastic leukemia - 600 mg of Gleevec per day;
- For myelodysplastic and myeloproliferative diseases, 400 mg per day;
- In inoperable and metastatic malignant gastrointestinal stromal tumors - 400 mg per day;
- With adjuvant therapy of gastrointestinal stromal tumors - 400 mg per day. When recurrent, inoperable, metastatic protruding dermatofibrosarcoma - 800 mg per day;
- In case of systemic mastocytosis in the absence of D816V c-KIT mutations, 400 mg of Gleevec per day;
- In systemic mastocytosis caused by abnormal FIP1L1-PDGFR alpha tyrosine kinase - 100 mg per day;
- With hypereosinophilic syndrome and chronic eosinophilic leukemia - 400 mg per day. In hypereosinophilic syndrome and chronic eosinophilic leukemia caused by abnormal FIP1L1-PDGFR alpha tyrosine kinase, 100 mg per day, followed by dosage increase to 400 mg per day.
When using Gleevec, various adverse reactions often develop:
- Blood system: neutropenia, anemia; thrombocytopenia, pancytopenia, febrile neutropenia;
- Nervous system: headache, dizziness, taste disturbance, paresthesia, hypesthesia;
- Organ vision: eyelid edema, conjunctival hemorrhage, increased tearing, dry eye syndrome, conjunctivitis, blurred vision;
- Respiratory system: nosebleeds, cough, shortness of breath;
- The digestive system: nausea, diarrhea, vomiting, dyspepsia, bloating, constipation, flatulence, dry mouth, gastritis;
- Bile paths: increased activity of liver enzymes;
- Dermatological reactions: dermatitis, periorbital edema, skin rash, eczema, pruritus, erythema, dry skin, night sweats;
- General disorders: edema, increase or decrease in body weight, fatigue, fever, weakness, chills.
When applying Gleevec, it should be borne in mind that:
- The drug treatment is carried out only under strict medical supervision;
- During therapy, it is necessary to regularly perform clinical blood tests, monitor liver function, and body mass of patients;
- Patients who have undergone thyroidectomy and receive replacement therapy with levothyroxine sodium should regularly monitor the level of TSH;
- At the beginning of treatment, the condition of the digestive tract should be monitored in patients with metastatic malignant gastrointestinal stromal tumors.
Structural analogues of Glivec are such drugs as Genfatinib, Gemfatinib, Imatinib, Imaglib, Imatib, Histamel, Neopax, Filakhromin.
Terms and conditions of storage
Gleevec is stored at a temperature of not more than 30º in places with limited access of children not more than three years.