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 below (table 2). 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 (12%). 5%). The most common adverse reaction requiring dosage reduction and/or treatment interruption was thrombocytopenia (7%). 1). 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 Table 2: Summary of adverse reactions reported in Phase 3 studies in adults with myelofibrosis System organ class (SOC) Adverse reaction Frequency category Infections and infestations Urinary tract infection, upper respiratory tract infection, pneumonia, nasopharyngitis, COVID-19, cystitis, bronchitis, oral herpes, sinusitis, herpes zoster, cellulitis, respiratory tract infection, sepsis, lower respiratory tract infection, oral candidiasis, skin infection, gastroenteritis Common COVID-19 pneumonia Uncommon Blood and lymphatic system disorders Thrombocytopeniaa Very common Neutropeniab Common Metabolism and nutrition disorders Vitamin B1 deficiency Common Nervous system disorders Dizziness, headache Very common Syncope, peripheral neuropathyc, paraesthesia Common Eye disorders Blurred vision Common Ear and labyrinth disorders Vertigo Common 10 System organ class (SOC) Adverse reaction Frequency category Vascular disorders Hypotension, haematoma, flushing Common Respiratory, thoracic and mediastinal disorders Cough Very common Gastrointestinal disorders Diarrhoea, abdominal pain, nausea Very common Vomiting, constipation Common Skin and subcutaneous tissue disorders Rashd Common Musculoskeletal and connective tissue disorders Arthralgia, pain in extremity Common General disorders and administration site conditions Asthenia, fatigue Very common Pyrexia Common Investigations Alanine transaminase (ALT) increased, aspartate transaminase (AST) increased Common Injury, poisoning and procedural complications Contusion Common a Thrombocytopenia includes platelet count decreased.
b Neutropenia includes neutrophil count decreased. c Peripheral neuropathy includes peripheral sensory neuropathy, peripheral motor neuropathy, neuropathy peripheral, peripheral sensorimotor neuropathy, neuralgia, and polyneuropathy.
d Rash includes rash maculo-papular, rash erythematous, drug eruption, rash follicular, rash macular, and rash pustular. 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). 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).
5% (11/448). 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). 7% (3/448). 2% (1/448) of patients, respectively.
Reversible drug-induced liver injury has been reported in patients with myelofibrosis treated with Omjjara in clinical trials. Rash Cases of rash (including a case of Toxic Epidermal Necrolysis [TEN]) requiring hospitalisation have been reported in the post-marketing setting.
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 via the national reporting system listed in Appendix V.