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What is the drug TOFACITINIB-CHRMRAR

The drug TOFACITINIB-CHEMRAR contains the active substance tofacitinib, which belongs to the group of immunosuppressants (drugs that depress the immune system), inhibitors of the janus kinase family (enzymes involved in the transmission of signals to the cell of some small protein molecules – hormones and cytokines).

Dosage form and packaging

TOFACITINIB-CHEMRAR, 5 mg, film-coated tablets

Round biconvex tablets covered with a white film coating. On a cross-section, the tablet core is white or almost white in color.

TOFACITINIB-CHEMRAR, 10 mg, film-coated tablets

Round biconvex tablets, covered with a film-coated brown-red color. On a cross-section, the tablet core is white or almost white in color.

14 tablets in a contour cell package made of a combined material based on polyamide/aluminum foil/polyvinyl chloride (PA/Alu/PVC) and aluminum foil printed varnished.

4 contour cell packages together with a leaflet insert are placed in a pack of cardboard.

Indications for use

TOFACITINIB-CHEMRAR is indicated in adults over 18 years of age for the treatment of:

- moderate or severe active rheumatoid arthritis (a chronic disease that mainly causes joint pain and swelling) with an inadequate (inappropriate) response to one or more basic (standard) anti-inflammatory drugs;

- active psoriatic arthritis (an inflammatory joint disease often accompanied by psoriasis) with an inadequate response to one or more basic anti-inflammatory drugs;

- active ankylosing spondylitis (an inflammatory disease that mainly affects the spine) with an inadequate response to traditional therapy;

-  chronic plaque psoriasis of moderate or severe severity, when systemic therapy or phototherapy is indicated;

- ulcerative colitis: for induction (initial) and maintenance therapy of adult patients with moderate or severe active ulcerative colitis (chronic inflammatory disease of the colon mucosa) with insufficient response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitors;

- new coronavirus infection caused by COVID-19 in hospitalized adult patients with mild/moderate course and risk factors for severe course in the presence of pathological changes in the lungs corresponding to CT1-2, but not receiving invasive or non-invasive ventilation or extracorporeal membrane oxygenation (ECMO).

TOFACITINIB-CHEMRAR is indicated in patients aged 2 years and older for the treatment of:

- active polyarticular juvenile idiopathic arthritis (JIA). 

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.