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OMJJARA▼ (momelotinib) logo

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The Established OMJJARA▼ Safety Profile1,2

The safety of OMJJARA was evaluated on 3 randomised, active-controlled multicentre studies in adults with myelofibrosis (MOMENTUM, SIMPLIFY-1, and SIMPLIFY-2). Patients were treated with OMJJARA 200 mg daily in the randomised treatment period of the clinical trials (n=448).

Summary of Adverse Reactions

System Organ Class (SOC)1 Adverse Reaction1 Incidence, n (rate)2
Infections and infestations Infections 178 (39.7%)*
Blood and lymphatic system disorders Thrombocytopenia†
Neutropenia‡		 96 (21.4%)
27 (6%)
Metabolism and nutrition disorders Vitamin B1 deficiency 14 (3.1%)
Nervous system disorders Dizziness
Headache
Syncope
Peripheral neuropathy§
Paraesthesia		 58 (12.9%)
60 (13.4%)
8 (1.8%)
41 (9%)
31 (6.9%)
Eye disorders Blurred vision 12 (2.7%)
Ear and labyrinth disorders Vertigo 10 (2.2%)
Vascular disorders Hypotension
Haematoma
Flushing		 27 (6%)
10 (2.2%)
15 (3.3%)
Respiratory, thoracic, and mediastinal disorders Cough 45 (10%)
Gastrointestinal disorders Diarrhoea
Abdominal pain
Nausea
Vomiting
Constipation		 102 (22.8%)
48 (10.7%)
75 (16.7%)
36 (8%)
43 (9.6%)
Musculoskeletal and connective tissue disorders Arthralgia
Pain in extremity		 34 (7.6%)
24 (5.4%)
General disorders and administration site conditions Asthenia
Fatigue
Pyrexia		 49 (10.9%)
55 (12.3%)
41 (9.2%)
Investigations Alanine transaminase (ALT) increased
Aspartate transaminase (AST) increased		 21 (4.7%)
16 (3.6%)
Injury, poisoning and procedural complications Contusion 26 (5.8%)
  • The most common adverse reactions among patients treated with OMJJARA 200 mg daily were diarrhoea (23%), thrombocytopenia (21%), nausea (17%), headache (13%), fatigue (12%), asthenia (11%), abdominal pain (11%), and cough (10%).1
  • The most common severe adverse reaction (≥Grade 3) with OMJJARA was thrombocytopenia (12%).1
  • Thrombocytopenia was the most common adverse reaction leading to discontinuation (2%) and dosage reduction/treatment interruption (7%) of OMJJARA.1

Descriptions of Selected Adverse Reactions

Infections1

  • In the 3 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).

Thrombocytopenia1

  • In the 3 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 Neuropathy1

  • In the 3 randomised clinical trials, 8.7% (39/448) of patients treated with OMJJARA experienced peripheral neuropathy. The majority of cases were mild or moderate, while 1 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/AST1

  • In the 3 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.
  • Rash; Cases of rash (including a case of Toxic Epidermal Necrolysis [TEN]) requiring hospitalisation have been reported in the post-marketing setting.

Special warnings and precautions for use can be found in section 4.4 of the Summary of Product Characteristics.

Summary of product characteristics & Patient information leaflet for 100 mg, 150 mg and 200 mg film coated tablets

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INDICATION

OMJJARA is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Footnotes

*The pooled percentage reflects 178/448 patients receiving OMJJARA who reported at least 1 type of infection during the randomised treatment period of the clinical trials.2
†Thrombocytopenia includes platelet count decreased.1
‡Neutropenia includes neutrophil count decreased.1
§Peripheral neuropathy includes peripheral sensory neuropathy, peripheral motor neuropathy, neuropathy peripheral, peripheral sensorimotor neuropathy, neuralgia, and polyneuropathy.1

Abbreviations

ALT=alanine transaminase; AST=aspartate transaminase; MF=myelofibrosis.

References

  1. OMJJARA Summary of Product Characteristics (SPC), available on www.medicines.ie/medicines/omjjara-100-150-200-mg-film-coated-tablets-36329/spc. Last accessed: August 2025.
  2. Data on file, GlaxoSmithKline.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie.
Adverse events should also be reported to GlaxoSmithKline on 1800 244 255 or via online form https://gsk.public.reportum.com/.

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

Omjjara is a registered trademark of the GlaxoSmithKline group of companies.

August 2025 | PM-IE-MML-WCNT-250007