Omjjara Adverse Reactions

Summary of the safety profile: The safety of Omjjara, evaluated in three randomised, active-controlled, multicentre studies in adults with myelofibrosis (MOMENTUM, SIMPLIFY-1, and SIMPLIFY-2), is presented as follows (Table 4). Among patients treated with Omjjara 200 mg daily in the randomised treatment period of the clinical trials (n=448), the most common adverse reactions were diarrhoea (23%), thrombocytopenia (21%), nausea (17%), headache (13%), dizziness (13%), fatigue (12%), asthenia (11%), abdominal pain (11%), and cough (10%).
The most common severe adverse reaction (≥ Grade 3) was thrombocytopenia (11%). The most common adverse reaction leading to discontinuation of Omjjara was thrombocytopenia (2%). The most common adverse reaction requiring dosage reduction and/or treatment interruption was thrombocytopenia (7%).
Tabulated list of adverse reactions: The following adverse reactions have been identified in 448 patients exposed to Omjjara during a median duration of 24 weeks during clinical trials (see Pharmacology: Pharmacodynamics under Actions). Adverse reactions are listed by MedDRA system organ classification (SOC) and by frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as: Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1 000 to <1/100; Rare: ≥1/10 000 to <1/1 000. (See Table 4.)

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Description of selected adverse reactions: Infections: In the three randomised clinical trials, the most common infections were urinary tract infection (6%), upper respiratory tract infection (4.9%), pneumonia (3.6%), nasopharyngitis (2.9%), COVID-19 (2.7%), cystitis (2.7%), bronchitis (2.5%), and oral herpes (2.5%). The majority of infections were mild or moderate; the most frequently reported severe (≥ Grade 3) infections were pneumonia, sepsis, urinary tract infection, cellulitis, COVID-19 pneumonia, COVID-19, herpes zoster, cystitis, and skin infection. The proportion of patients discontinuing treatment due to an infection was 2% (9/448). Fatal infections were reported in 2.2% (10/448) of patients (most frequently reported COVID-19 and COVID-19 pneumonia).
Thrombocytopenia: In the three randomised clinical trials, 21% (94/448) of patients treated with Omjjara experienced thrombocytopenia; 12% (54/448) of patients treated with Omjjara experienced severe thrombocytopenia (≥ Grade 3). The proportion of patients discontinuing treatment due to thrombocytopenia was 2.5% (11/448).
Peripheral neuropathy: In the three randomised clinical trials, 8.7% (39/448) of patients treated with Omjjara experienced peripheral neuropathy. The majority of cases were mild or moderate, while one of the 39 cases was severe (≥ Grade 3). The proportion of patients discontinuing treatment due to peripheral neuropathy was 0.7% (3/448).
Elevated ALT/AST: In the three randomised clinical trials, new or worsening elevations of ALT and AST (all grades) occurred in 20% (88/448) and 20% (90/448), respectively, of patients treated with Omjjara; Grade 3 and 4 transaminase elevations occurred in 1.1% (5/448) and 0.2% (1/448) of patients, respectively. Reversible drug-induced liver injury has been reported in patients with myelofibrosis treated with Omjjara in clinical trials.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.