Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
The recommended dose of Olumiant is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see section 5.1).
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 × 109 cells/L, an absolute neutrophil count (ANC) less than 1 × 109 cells/L, or who have a haemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above these limits (see section 4.4).
The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Olumiant is not recommended for use in patients with creatinine clearance <30 mL/min (see section 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. Olumiant is not recommended for use in patients with severe hepatic impairment (see section 5.2).
The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see section 4.5).
Clinical experience in patients ≥75 years is very limited and in these patients a starting dose of 2 mg is appropriate.
The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
Oral use.
Olumiant is to be taken once daily with or without food and may be taken at any time of the day.
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 24 hours. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Polyvinylchloride/aluminium/oriented polyamide – aluminium perforated unit dose blisters in cartons of 28 × 1 or 84 × 1 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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