OLUMIANT Film-coated tablets Ref.[6377] Active ingredients: Baricitinib

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands

Therapeutic indications

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).

Posology and method of administration

Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.

Posology

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).

Renal impairment

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).

Hepatic impairment

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).

Co-administration with OAT3 inhibitors

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).

Elderly

Clinical experience in patients ≥75 years is very limited and in these patients a starting dose of 2 mg is appropriate.

Paediatric population

The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Method of administration

Oral use.

Olumiant is to be taken once daily with or without food and may be taken at any time of the day.

Overdose

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

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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.

Special precautions for disposal and other handling

No special requirements for disposal.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.