OMJJARA FILM-COATED TABLET 100 MG [SIN17131P]

Product Info

OMJJARA FILM-COATED TABLET 100 MG

[SIN17131P]

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

Treatment should be initiated and monitored by physicians experienced in the use of anti-cancer medicinal products.

Posology

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose modifications
Dose modifications should be considered for haematologic and non-haematologic toxicities (Table 1).

Treatment with Omjjara should be discontinued in patients unable to tolerate 100 mg once daily.

Duration of use
Treatment may be continued for as long as the benefit-risk remains positive for patients, as assessed by the treating physician.

Missed dose
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.

Special populations

Elderly
No dose adjustment is required for patients who are aged 65 years and older (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 disease.

Hepatic impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The safety and efficacy of Omjjara in children and adolescents less than 18 years of age have not been established. No data are available.

Method of administration

Omjjara is for oral use only and can be taken with or without meals (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Pregnancy and breast-feeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).