Disease-related splenomegaly or symptoms in adults w/ moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis & who are Janus Kinase (JAK) inhibitor naïve or have been treated w/ ruxolitinib.
Discontinue treatment in patients unable to tolerate 100 mg once daily. Risk of infections, including serious & fatal bacterial & viral infections (including COVID-19). Do not initiate treatment in patients w/ active infections. Reports of increased HBV-DNA titer, w/ or w/o associated elevations in ALT or AST, in patients w/ chronic HBV infection taking JAK inhibitors, including Omjjara. Risk of new-onset severe (grade ≥3) thrombocytopenia & neutropenia. Perform CBC (including platelet count) & LFTs before initiating treatment, periodically during treatment, & as clinically indicated. Major adverse CV events, deep venous thrombosis, pulmonary embolism, & lymphoma & other malignancies have been reported, however, a causal relationship has not been established. Consider benefits & risks for the individual patient prior to initiating or continuing therapy, particularly in patients ≥65 yr, patients who are current or past long-time smokers, & patients w/ history of ASCVD or other CV risk factors. Do not use in combination w/ other JAK inhibitors. Monitor for adverse reactions w/ co-administration of certain medicinal products (eg, sensitive BCRP substrates). Additional monitoring of clinical signs & symptoms of myelofibrosis when concomitantly used w/ strong CYP3A4 inducers. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Has not been studied in patients w/ ESRD. May cause foetal harm. Women of childbearing potential should avoid becoming pregnant whilst receiving Omjjara. Women using systemically acting hormonal contraceptives should add a barrier method during treatment & for at least 1 wk after the last dose of Omjjara. Safety & efficacy in childn & adolescents <18 yr have not been established.
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