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▼OMJJARA has a novel MOA combination that inhibits JAK1/JAK2* and ACVR11,2

JAK-STAT and ACVR1 pathway diagram JAK-STAT and ACVR1 pathway diagram
  • MF is a myeloproliferative neoplasm (MPN) known to be associated with constitutive activation and dysregulated JAK signalling
  • JAK1 and JAK2 recruit and activate STAT proteins that control gene transcription impacting inflammation, haematopoiesis, and immune regulation
  • ▼OMJJARA inhibits the ACVR1 signalling pathway, suppressing hepcidin levels and resulting in restoration of haematopoiesis

*▼OMJJARA is a small-molecule inhibitor of wild-type Janus kinase 1 and 2 (JAK1/JAK2) and mutant JAK2V617F.

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MOMENTUM Efficacy (JAKi-Experienced)

Safety Profile

Dosing and Administration

Safety info:

Contraindications:
- Hypersensitivity to the active substance or to any of the excipients.
- Pregnancy and breast-feeding.

Undesirable side effects:
Very common: Thrombocytopenia, dizziness, headache, cough, diarrhoea, abdominal pain, nausea, asthenia and fatigue.
Common: 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, neutropenia, vitamin B1 deficiency, syncope, peripheral neuropathy, paraesthesia, blurred vision, vertigo, hypotension, haematoma, flushing, vomiting, constipation, arthralgia, pain in extremity, pyrexia, alanine transaminase(ALT) increased, aspartate transaminase (AST) increased and contusion.

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.

Abbreviations

ACVR1=activin A receptor type 1; BMP=bone morphogenetic protein; EPOR=erythropoietin receptor; JAK=Janus kinase; MF=myelofibrosis; MOA=mechanism of action; MPL=myeloproliferative leukaemia virus; P=phosphorylation; SMAD=mothers against decapentaplegic homolog; STAT=signal transducer and activator of transcription.

References

  1. ▼OMJJARA Summary of Product Characteristics.
  2. Chifotides HT, et al. J Hematol Oncol. 2022;15(1):7.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
 Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: https://moh.gov.om/en/

 دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
https://moh.gov.om/en/ : الموقع االكتروني

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PM-RCH-MML-WCNT-250001 | Date of preparation: September 2025