Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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.
Treatment should be initiated and monitored by physicians experienced in the use of anti-cancer medicinal products.
Omjjara should not be used in combination with other JAK inhibitors.
The recommended dose is 200 mg once daily.
Complete blood cell count and liver function tests must be performed before initiating treatment, periodically during treatment, and as clinically indicated (see section 4.4).
Dose modifications should be considered for haematologic and non-haematologic toxicities (table 1).
Table 1. Dose modifications for adverse reactions:
| Haematologic toxicities | ||
| Thrombocytopenia | Dose modificationa | |
| Baseline platelet count | Platelet count | |
| ≥100 × 109/L | 20 × 109/L to <50 × 109/L | Reduce daily dose by 50 mg from the last given dose. |
| <20 × 109/L | Interrupt treatment until platelets recover to 50 × 109/L Restart Omjjara at a daily dose of 50 mg below the last given doseb. | |
| ≥50 × 109/L to <100 × 109/L | <20 × 109/L | Interrupt treatment until platelets recover to 50 × 109/L. Restart Omjjara at a daily dose of 50 mg below the last given doseb. |
| <50 × 109/L | <20 × 109/L | Interrupt treatment until platelets recover to baseline. Restart Omjjara at a daily dose of 50 mg below the last given doseb. |
| Neutropenia | Dose modificationa | |
| ANC <0.5 × 109/L | Interrupt treatment until ANC ≥0.75 × 109/L. Restart Omjjara at a daily dose of 50 mg below the last given doseb. | |
| Non-haematologic toxicities | ||
| Hepatotoxicity (unless other apparent causes) | Dose modificationa | |
| 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 doseb If reoccurrence of ALT or AST elevations >5 × ULN, permanently discontinue Omjjara | |
| Other non-haematologic | Dose modificationa | |
| Grade 3 or higherc Grade 2 or higherc 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 doseb | |
ANC = absolute neutrophil count; ALT = alanine transaminase; AST = aspartate transaminase; ULN = upper limit of normal.
a Reinitiate or escalate treatment up to starting dosage as clinically appropriate.
b May reinitiate treatment at 100 mg if previously dosed at 100 mg.
c Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events per (CTCAE).
Treatment with Omjjara should be discontinued in patients unable to tolerate 100 mg once daily.
Treatment may be continued for as long as the benefit-risk remains positive for patients, as assessed by the treating physician.
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.
No dose adjustment is required for patients who are aged 65 years and older (see section 5.2).
No dose adjustment is required for patients with renal impairment (>15 mL/min).
Omjjara has not been studied in patients with end-stage renal disease.
No dose adjustment is recommended for patients with mild or moderate hepatic impairment (see section 4.4). The recommended starting dose of Omjjara is 150 mg once daily in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
The safety and efficacy of Omjjara in children and adolescents less than 18 years of age have not been established. No data are available.
Omjjara is for oral use only and can be taken with or without meals (see section 5.2).
If overdose is suspected, the patient should be monitored for any signs or symptoms of adverse reactions or effects, and appropriate standard of care measures should be instituted immediately. Further management should be as clinically indicated. Haemodialysis is not expected to enhance the elimination of momelotinib.
3 years.
Store in the original bottle in order to protect from moisture. Do not remove the desiccant. Do not swallow the desiccant. This medicinal product does not require any special temperature storage conditions.
Each carton contains one white, high-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap and induction-sealed, aluminium faced liner. Each bottle contains 30 film-coated tablets, a silica gel desiccant, and polyester coil.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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