Omjjara Special Precautions

Infections: Infections, including serious and fatal bacterial and viral infections (including COVID-19), have occurred in patients treated with Omjjara (see Adverse Reactions). Omjjara should not be initiated in patients with active infections. Physicians should carefully observe patients receiving Omjjara for signs and symptoms of infection (including but not limited to fever, cough, diarrhoea, vomiting, nausea, and pain upon urination) and initiate appropriate treatment promptly.
Hepatitis B reactivation: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine transaminase (ALT) or aspartate transaminase (AST), have been reported in patients with chronic hepatitis B virus (HBV) infection taking JAK inhibitors, including Omjjara. The effect of Omjjara on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection who receive Omjjara should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.
Thrombocytopenia and neutropenia: New onset of severe (Grade ≥3) thrombocytopenia and neutropenia was observed in patients treated with Omjjara (see Adverse Reactions). A complete blood count including platelet count should be obtained before initiating treatment with Omjjara, periodically during treatment, and as clinically indicated.
Dose interruption or reduction may be required (see Dosage & Administration).
Hepatic monitoring: Liver function tests should be obtained before initiating treatment with Omjjara, periodically during treatment, and as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, dose interruption or reduction may be required (see Dosage & Administration).
Major adverse cardiovascular events (MACE): In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of MACE, defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors.
Events of MACE have been reported in patients receiving Omjjara, however, a causal relationship has not been established. Prior to initiating or continuing 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.
Thrombosis: In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of venous thromboembolic events (VTE) including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
Events of DVT and PE have been reported in patients receiving Omjjara. However, a causal association has not been established. In patients with myelofibrosis treated with Omjjara in clinical trials, the rates of thromboembolic events were similar in Omjjara and control-treated patients. Prior to initiating or continuing therapy with Omjjara, the benefits and risks for the individual patient should be considered particularly in patients with cardiovascular risk factors (see also Major adverse cardiovascular events [MACE] as previously mentioned).
Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.
Second primary malignancies: In a large randomised active controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors.
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including Omjjara. However, a causal association has not been established.
Interactions: Based on the potential of Omjjara to increase the plasma concentrations of certain medicinal products (e.g., sensitive breast cancer resistance protein [BCRP] substrates, such as rosuvastatin and sulfasalazine), patients should be monitored for adverse reactions with co-administration (see Interactions).
Co-administration of strong cytochrome P450 (CYP) 3A4 inducers may lead to decreased exposure of Omjjara and consequently a risk for reduced efficacy. Therefore, additional monitoring of the clinical signs and symptoms of myelofibrosis is recommended with concomitant use of Omjjara and strong CYP3A4 inducers (including but not limited to carbamazepine, phenobarbital, phenytoin, and St John's wort [Hypericum perforatum]) (see Interactions).
Women of childbearing potential: Given uncertainties whether Omjjara may reduce the effectiveness of hormonal contraceptives, women using oral hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose of Omjjara (see Interactions and Use in Pregnancy & Lactation).
Excipients with known effect: Omjjara contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Omjjara may have a minor influence on the ability to drive and use machines, dizziness or blurred vision may occur. Patients who experience dizziness or blurred vision after taking Omjjara should observe caution when driving or using machines (see Adverse Reactions).