Redivek (imatinib) hard capsules 400 mg. №30

Description

Redivek (imatinib) hard capsules 400 mg. №30

Composition 

active substance: imatinib;

1 hard capsule contains imatinib mesylate equivalent to imatinib 100 mg or 400 mg;

excipients: crospovidone, sodium stearyl fumarate;

hard capsules of 100 mg each: gelatin, water, sodium lauryl sulfate, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172);

hard capsules of 400 mg each: gelatin, water, sodium lauryl sulfate, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172).

Medicinal form

Capsules are hard.

The main physical and chemical properties:

100 mg capsules: orange to grayish-orange size “1” hard gelatin opaque capsules with “RDY” on the cap and “100” on the body in red ink, containing an off-white to brownish-yellow granular powder ;

400 mg capsules: Very dark yellow to brownish-orange, size “00” hard gelatin opaque capsules with “RDY” on cap and “400” on body, printed in red ink, containing off-white to brownish-yellow color granulated powder.

Pharmacotherapeutic group

Antineoplastic agents. Other antineoplastic agents. Protein kinase inhibitors. Imatinib.
ATX code L01X E01.

Pharmacological properties

Imatinib is a small molecule protein tyrosine kinase inhibitor that potently inhibits the Bcr-Abl tyrosine kinase in vitro, at the cellular level and in vivo, as well as a number of receptor tyrosine kinases: Kit, stem cell factor receptor encoded by the c-Kit proto-oncogene, discoidin domain receptors (DDR1 and DDR2), colony-stimulating factor receptor (CSF-1R), and platelet-derived growth factor alpha and beta receptors (PDGFR-α and PDGFR-β). Imatinib can also inhibit cellular activity mediated by the activation of these receptor kinases.

The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl-positive cell lines and newly infected leukemic cells from patients with Ph-positive CML and acute lymphoblastic leukemia (ALL). In vivo, the compound exerts an antitumor effect with monotherapy in an animal model of Bcr-Abl-positive tumor cells. Imatinib is also an inhibitor of platelet-derived growth factor (TGF) and stem cell factor (SFC) receptor tyrosine kinases, c-Kit, and inhibits TGF- and FSC-mediated cellular changes. In vitro, imatinib inhibits proliferation and stimulates apoptosis in gastrointestinal stromal tumor (GISC) cells expressing activating mutations of the kit gene. Constitutive activation of the TGF receptor or protein tyrosine kinase Abl as a result of binding to various proteins or constitutive release of TGF are involved in the pathogenesis of MDS/MPZ (myelodysplastic/myeloproliferative tumors), HES/CHEL (hypereosinophilic syndrome/chronic eosinophilic leukemia) and VDFS (bulging dermatofibrosarcoma). Imatinib inhibits signaling and cell proliferation mediated by deregulated TGF receptor and Abl kinase activity.

Indications

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.

Contraindications

The drug Redivek 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 Redivek 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

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.