Neopax is an antineoplastic agent.
Neopax is indicated for the treatment of:
adults and children with Ph+ CML in chronic phase after failure of alpha interferon therapy or in accelerated phase or blast crisis; adults and children with newly diagnosed acute lymphoblastic leukemia (Ph+ ALL), with a positive Philadelphia chromosome, as part of chemotherapy; adult patients with relapsed or refractory Ph+ ALL, as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (TGF) gene rearrangements.
Warehouse
1 film-coated tablet contains 100 mg of imatinib (as imatinib mesylate); excipients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate; film-coating composition: white opadry (contains polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc), yellow iron oxide (E 172), red iron oxide (E 172).
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Method of application
Dosage for adult patients with CML
The recommended dose of Neopax is 400 mg/day for adult patients with chronic phase CML. Chronic phase CML is defined as the presence of the following criteria: < 15% blasts in blood and bone marrow, < 20% basophils in peripheral blood, platelets > 100 * 109/L.
For adult patients in the acceleration phase, the recommended dose of Neopax is 600 mg per day.
Accelerated phase is defined by the presence of any of the following blasts: blasts ≥15% but <30% in blood or bone marrow, blasts and promyelocytes ≥30% in blood or bone marrow (provided blasts <30%), peripheral blood basophils ≥20%, platelets 100*109/L, not related to therapy.
Application features
Concomitant use of imatinib with other medicinal products may result in drug interactions. Caution should be exercised when imatinib is administered with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (such as cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives.
Pregnant women
Imatinib should not be used during pregnancy unless clearly necessary.
Children
There is no experience with the use of Neopax in children with CML under 2 years of age, as well as in children with Ph+ ALL under 1 year of age.
Experience in children with MDS/MPD, VDFS, GISP and HES/CEL is very limited.
The safety and efficacy of imatinib in children with MDS/MPZ, DFSP, GISP, and HES/CEL (under 18 years of age) have not been established in clinical trials. Published data are available, but no dosing recommendations can be made.
Drivers
Patients should be warned that they may experience adverse effects such as dizziness, blurred vision, or drowsiness during treatment with imatinib. Therefore, caution should be exercised when driving or operating machinery.
Overdose
Experience with doses higher than the recommended therapeutic dose is limited. Isolated reports of overdose with imatinib have been spontaneous or published. In the event of overdose, the patient should be monitored and appropriate symptomatic treatment should be given. In general, the outcome of such cases has been reported as “improvement” or “recovery”.
Side effects
Infections and infestations: herpes zoster, herpes simplex, nasopharyngitis, pneumonia, sinusitis, cellulitis, upper respiratory tract infections, influenza, urinary tract infections, gastroenteritis, sepsis.
Immunological disorders: anaphylactic shock.
From the hematopoietic and lymphatic system: neutropenia, thrombocytopenia, anemia.
Metabolism and absorption disorders: hypokalemia, increased appetite, hypophosphatemia, decreased appetite, dehydration, gout, hyperuricemia, hypercalcemia, hyperglycemia, hyponatremia.
Storage conditions
This medicinal product does not require any special storage conditions.
Keep out of reach of children.
