Redivek (imatinib) hard capsules 400 mg. №30


For the treatment of adults and children with newly diagnosed Ph-positive (with the presence of the Philadelphia chromosome (bcr-abl)) chronic myeloid leukemia (Ph + CML), for whom bone marrow transplantation cannot be considered a first-line therapy; for the treatment of adults and children With pH + CML in the chronic phase when interferon alpha therapy is ineffective, or in the acceleration phase, or in the blast crisis phase; as part of chemotherapy for the treatment of adults and children with newly diagnosed Ph-positive (with the presence of the Philadelphia chromosome) acute lymphoblastic leukemia (Ph + ALL) monotherapy of adult patients with relapsed or refractory acute lymphoblastic leukemia (Ph + ALL) for the treatment of adult patients with Myelodysplastic / myeloproliferative diseases (MDS / MPZ) associated with rearrangement of the platelet growth factor receptor (TFR) gene) for the treatment of adult patients with late-stage hyperosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (HEL) with FIP 1 l 1-Pdgfra rearrangement; for the treatment of adult patients with Kit (CD 117) – positive inoperable and / or metastatic malignant Gastrointestinal stromal tumors (GISP) adjuvant therapy of adult patients with a significant risk of relapse after resection of Kit (CD117)-positive GISP. Patients with a low or very low risk of relapse are prescribed adjuvant therapy; for the treatment of adult patients with inoperable exploding dermatofibrosarcoma (vdfso) and adult patients with recurrent and / or metastatic vdfso that cannot be surgically removed.



Composition Redivek
Main active ingredient: imatinib.
Excipients included in the preparation: crospovidone, sodium stearyl fumarate, gelatin, water, sodium lauryl sulfate, etc.

Release form
Available in capsule form, 400 mg imatinib.

Pharmacological properties Redivek
This pharmaceutical product belongs to the drug group of antineoplastic agents, protein kinase inhibitors, and is used in the treatment of various oncological diseases.
The main active ingredient is imatinib, an antineopolastic agent with the ability to inhibit protein kinase. A subclass of enzymes, protein kinases, has the ability to modify proteins (the position of proteins inside the cell, their interaction with other proteins).
Due to the ability of imatinib to suppress (inhibit) enzymes involved in the metabolism of cell lines, including cells affected by leukemia, myeloid leukemia, acute lymphoid leukemia.
It has antitumor activity against malignant neoplasms when used as a monotherapeutic agent. It also has the ability to inhibit (inhibit) receptors that promote cell growth, to activate kit mutations.
It is highly effective due to the overall response rate of the hematological and cytogenetic systems of the body, especially in patients suffering from acute lymphoblastic leukemia, as well as in patients diagnosed with malignant gastrointestinal stromal tumors.

This drug Redivek is used to treat certain cancers in both adults and children.
In particular, they apply:

  • in the treatment of chronic myeloid leukemia (CML), if bone marrow transplantation is not expected, or after unsuccessful treatment with interferons, other forms of this type of cancer;
  • with chemotherapy for newly diagnosed acute lymphoblastic leukemia;
  • as monotherapy for acute lymphoblastic leukemia;
  • for the treatment of certain types of myelodysplastic / myeloproliferative diseases;
  • treating hypereosinophilic syndrome and / or chronic eosinophilic leukemia;
  • treatment of metastatic malignant gastrointestinal stromal tumors;
  • dermatofibrosarcoma treatment.

The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
In pediatrics, it can be used from 2 years of age.

Application during pregnancy and lactation
This drug is not used in the treatment of pregnant women.
If it is necessary to take the drug during breastfeeding, then during treatment, lactation should be suspended.

Method of administration and dosage
The drug Redivek is taken orally.
The treatment regimen is determined by an experienced oncologist, it is highly individual and depends on many factors – the type of disease, the course of the disease, the patient’s body condition, response to treatment, and others.
The drug is taken with food, and washed down with a significant amount of water to reduce the risk of side effects from the digestive system.
If the doctor has prescribed a daily dosage of 400 or 600 mg, the drug is taken once a day.
If a dosage of 800 mg is prescribed, the intake of this daily dose is divided into 2 doses per day.
The duration of the course of treatment depends on the reaction of the body to the treatment, it can last from 3 to 30 months or more.
Pediatric dosage is calculated based on the patient’s body area, from 340 to 570 mg per 1 square meter of the patient’s body surface.

Overdose cases are extremely rare.
An overdose of 1200 mg per day for more than 10 days can cause:

  • nausea, vomiting, diarrhea, rash;
  • thrombocytopenia, milagia, pancytopenia;
  • headaches, decreased appetite, facial swelling.

These symptoms are reversible. In this case, symptomatic therapy is recommended.

Side effects
Possible side effects:

  • nausea, vomiting, muscle cramps, swelling of the extremities;
  • increased transaminase levels, hyperbilirubinemia;
  • herpes, nasopharyngitis, infections and inflammation of the upper respiratory tract, urinary tract, gastroenteritis, sepsis, mycoses;
  • tumor lysis syndrome, tumor hemorrhage / necrosis;
  • neutropenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, eosinophilia, lymphadenopathy;
  • anorexia, hypokalemia, dehydration, gout, hyperuricemia, hypercalcemia, hyperglycemia, hyponatremia, hyperkalemia, hypomagnesemia;
  • depression, anxiety, dizziness;
  • eyelid edema, conjunctivitis, blepharitis, cataract, glaucoma, cerebral edema, hearing loss;
  • disruption of the CVS;
  • disruption of the digestive tract, possible bleeding in the digestive tract;
  • skin reactions – dermatitis, rash;
  • myalgia, arthralgia, myopathy, growth retardation in children.

Storage conditions and periods
The shelf life is up to 2 years.
Storage temperature – no more than 25 ° С.