ONCOLOGY
SUNITINIB-CHEMRAR
Capsules
Pharmacotherapy group:
antitumor agents; protein kinase inhibitors; other protein kinase inhibitors
INN:
Sunitinib
Dosages:
12.5 mg; 25 mg; 50 mg
Available on a doctor's
prescription
What is the drug SUNITINIB-CHEMRAR
The drug SUNITINIB-CHEMRAR
contains the active substance sunitinib (belongs to the so-called class of
protein kinase inhibitors). Sunitinib is used for the treatment of malignant
tumors due to its ability to inhibit the activity of a special group of
proteins involved in the growth and spread of cancer cells.
Dosage form and packaging
SUNITINIB-CHEMRAR, 12.5 mg,
capsules
Solid gelatin capsules No.4 with
a brown body and lid.
SUNITINIB-CHEMRAR, 25 mg,
capsules
Solid gelatin capsules No.3 with
a brown body and a light brown lid.
SUNITINIB-CHEMRAR, 50 mg,
capsules
Solid gelatin capsules No.2 with
a light brown body and lid.
The contents of the capsules are
yellow to orange powder.
7 capsules in a contour cell package (blister) made
of a combined material based on polyvinyl chloride/polychlorotrifluoroethylene and aluminum foil printed varnished.
4 contour cell packages (blisters) together with the
insert sheet are placed in a pack of cardboard for consumer packaging.
Indications for use
The drug SUNITINIB-CHEMRAR is indicated for use in adults over the age of 18years:
- Gastrointestinal stromal tumors (GIST) (a type of gastrointestinal tract tumor), if imatinib (another antitumor drug) is ineffective or intolerant.
- Advanced and / or metastatic renal cell carcinoma (mRCC) (a type of kidney cancer that has spread to other parts of the body) in patients who have not previously received specific treatment.
- Advanced and / or metastatic renal cell carcinoma with no effect from cytokine therapy.
- Unresectable (when the tumor is not subject to surgical treatment) or metastatic highly differentiated neuroendocrine pancreatic tumors (PNETs) in adults with progressive disease.
- Adjuvant therapy (additional drug therapy aimed at destroying latent metastases after radical removal of a malignant tumor) in patients at high risk of relapse of renal cell carcinoma (a form of kidney cancer) after nephrectomy (kidney removal surgery).
Efficacy and safety studies
In accordance with current legislation, the drug has proven its effectiveness, safety and quality during state registration. For registration purposes, a bioequivalence study was conducted with the original (reference) medicinal product.