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OMJJARA▼ (momelotinib) Safety Profile

Summary of the safety profile

Refer to the OMJJARA summary of product characteristics (SmPC) for more information.1

Among patients treated with Omjjara in the randomized 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%).1

Dose modifications should be considered for haematologic and non-haematologic toxicities as outlined in table 3.1

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Safety profile summary of Omjjara is presented in the table below.1

Table 1: Adverse events

The following 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

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 Thrombocytopenia* Very Common
Neutropenia** Common
Metabolism and nutrition disorders Vitamin B1 deficiency Common
Nervous system disorders Dizziness, headache Very common
Syncope, peripheral neuropathy†,
paraesthesia		 Common
Eye disorders Blurred vision Common
Ear and labyrinth disorders Vertigo Common
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 Rash‡ Common
Musculoskeletal and connective tissue disorders Arthralgia, pain in extremity Common
General disorders and administrative 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

*Thrombocytopenia includes platelet count decreased
**Neutropenia includes neutrophil count decreased
†Peripheral neuropathy includes peripheral sensory neuropathy, peripheral motor neuropathy, neuropathy peripheral, peripheral sensorimotor neuropathy, neuralgia and polyneuropathy
‡Rash includes rash maculo-papular, rash erythematous, drug eruption, rash follicular, rash macular, and rash pustular

Infections

In the 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. Fatal infections were reported in 2.2% (10/448) of patients (most frequently reported COVID-19 and COVID-19 pneumonia). The proportion of patients discontinuing treatment due to an infection was 2% (9/448).

Thrombocytopenia

In the 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 most common adverse reaction leading to discontinuation of Omjjara was thrombocytopenia (2.5%). The most common adverse reaction requiring dosage reduction and/or treatment interruption was thrombocytopenia (7%).

Peripheral neuropathy

In the clinical trials, 8.7% (39/448) of patients treated with Omjjara experienced peripheral neuropathy. 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 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.

Please refer to the SmPC for further information before prescribing

Dosing

OMJJARA is available in 3 dosage strengths1: 200 mg, 150 mg and 100 mg

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For your eligible adult Hb <10 g/dL patients with MF: once-daily, oral OMJJARA

Before starting OMJJARA

  • Contraindications: In patients with hypersensitivity to the active substance or to any of the excipients (please see SmPC for list); in patients who are breastfeeding or who are, or may be pregnant.1
  • Not to be initiated in patients with: Active infections, rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption (OMJJARA contains lactose monohydrate).1
  • Interactions: Please refer to SmPC for full list and check drug-drug interactions before initiating OMJJARA.1
  • The recommended dosage of OMJJARA is 200 mg orally, once daily.1
  • For patients with severe hepatic impairment Child-Pugh Class C, the recommended starting dosage of OMJJARA is 150 mg orally, once daily.1
  • OMJJARA can be taken with or without food. If a dose of OMJJARA is missed, the next scheduled dose should be taken the following day. Two doses should not be taken at the same time to make up for the missed dose.1
  • Complete the following assessments prior to starting treatment with OMJJARA:1
    • Complete blood count (including platelets)
    • Liver function tests
  • OMJJARA should not be used in combination with other JAK inhibitors.1
  • Prior to initiating therapy with OMJJARA, the benefits and risks for the individual patient should be considered particularly in patients 65 years of age and older, patients who are current or past long-time smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors.1
  • In the SIMPLIFY-1 clinical trial, patients transitioning from ruxolitinib to OMJJARA in the open-label phase were immediately administered OMJJARA without ruxolitinib tapering.1


For more information please refer to the SmPC
JAK, Janus-associated kinase; MF, myelofibrosis

Treatment to be initiated and monitored by physicians experienced in the use of anti-cancer medicinal products1

Table 2: Information for use

Whilst on OMJJARA Assessments: Complete blood cell count (including platelets) and liver function tests periodically during treatment, and as clinically indicated1
Infections: Observe patients for signs and symptoms of infection and initiate appropriate treatment promptly1
Hepatitis B reactivation: Chronic HBV infection should be treated and monitored according to clinical HBV guidelines1
MACE / Thrombosis: The benefits and risks of OMJJARA should be considered particularly in patients who are ≥65 years of age, current or past long-term smokers, or who have a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors. Symptoms of thrombosis should be promptly evaluated and treated appropriately1
Women of childbearing potential: The effectiveness of systemically acting hormonal contraceptives co-administered with OMJJARA may be reduced.1 Women using systemically acting hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of OMJJARA.1
Ability to drive and use machines: Patients who experience dizziness or blurred vision after taking OMJJARA should observe caution when driving or using machines1
Dose modifications In line with the SmPC, dose modifications/discontinuations should be considered for haematologic and non‑haematologic toxicities.1
Treatment with OMJJARA should be discontinued in patients unable to tolerate 100 mg once daily1
Refer to SmPC for detailed dosing information

HBV, hepatitis B virus; MACE, Major adverse cardiovascular events

Posology and special populations

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Hepatic impairment

For patients with severe hepatic impairment Child-Pugh Class C, the recommended starting dosage of OMJJARA is 150 mg orally once daily1

No dose adjustment is recommended for patients with mild to moderate hepatic impairment1

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Elderly

No dose adjustment is required for patients who are aged 65 years and older1

NA

Renal impairment

No dose adjustment is required for patients with renal impairment (>15 mL/min). OMJJARA has not been studied in patients with end-stage renal disease1

Refer to the OMJJARA SmPC for more information

Dose Modifications

Dose modification should be considered for haematologic and non-haematologic toxicities (refer to SmPC).1
Treatment with OMJJARA should be discontinued in patients unable to tolerate 100 mg once daily.1

Table 3: Dose modifications/ discontinuations for haematologic and non-haematologic toxicities1

Thrombocytopenia Dose modification*
Baseline platelet count Platelet count
≥100x109/L 20x109/L to <50x109/L
 Reduce daily dose by 50 mg from the last given dose
<20x109/L Interrupt treatment until platelets recover to 50x109/L
Restart OMJJARA at a daily dose of 50 mg below the last given dose**
≥50x109/L to
<100x109/L <20x109/L Interrupt treatment until platelets recover to 50x109/L
Restart OMJJARA at a daily dose of 50 mg below the last given dose**
<50x109/L <20x109/L Interrupt treatment until platelets recover to baseline
Restart OMJJARA at a daily dose of 50 mg below the last given dose**
Neutropenia Dose modification*
ANC <0.5x109/L Interrupt treatment until ANC ≥0.75x109/L
Restart OMJJARA at a daily dose of 50 mg below the last given dose**
Hepatotoxicity (unless other apparent causes) Dose modification*
ALT and/or AST >5 × ULN (or >5 × baseline, if baseline is abnormal) and/or total bilirubin >2 × ULN (or >2 × baseline, if baseline is abnormal)
  • Interrupt treatment until AST and ALT ≤2 × ULN or baseline and total bilirubin ≤1.5 × ULN or baseline
  • Restart OMJJARA at a daily dose of 50 mg below the last given dose**
  • If ALT or AST elevations >5 × ULN reoccur, permanently discontinue OMJJARA
Other non-haematologic Dose modification*
Grade 3 or higher†
Grade 2 or higher† bleeding		 Interrupt treatment until the toxicity resolves to Grade 1 or lower (or baseline)
Restart OMJJARA at a daily dose of 50 mg below the last given dose**
 

*Reinitiate or escalate treatment up to starting dosage as clinically appropriate.

**May reinitiate treatment at 100 mg if previously dosed at 100 mg.
†Graded using the National Cancer Institute CTCAE.

ANC, absolute neutrophil count. ALT, alanine transaminase; AST, aspartate transaminase; CTCAE, Common Terminology Criteria for Adverse Events; ULN, upper limit of normal

Please refer to the SmPC before prescribing.

INDICATION

Omjjara ▼ (momelotinib) is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis (MF), post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.1

Reference

  1. Omjjara UK SmPC

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@gsk.com

May 2026 | PM-GB-MML-WCNT-250008 (v1.0)