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

Treatment should be initiated by physicians experienced in the diagnosis and treatment of the conditions for which this medicinal product is indicated.

Posology

Rheumatoid arthritis

The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy, for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see section 4.4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. A dose of 2 mg once daily should 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).

Atopic dermatitis

Adults

The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at higher risk of VTE, MACE and malignancy, for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see section 4.4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. A dose of 2 mg once daily should 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).

Baricitinib can be used with or without topical corticosteroids. The efficacy of baricitinib can be enhanced when given with topical corticosteroids (see section 5.1). Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.

Children and adolescents (2 years of age and older)

The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily. A reduction to half the dose should be considered for patients who have achieved sustained control of disease activity with the recommended dose and are eligible for dose tapering.

Baricitinib can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.

Alopecia areata

The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is recommended for patients at higher risk of VTE, MACE and malignancy, for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see section 4.4). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. A dose of 2 mg once daily should 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).

Once a stable response has been achieved, it is recommended to continue treatment for at least several months, in order to avoid relapse. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 36 weeks of treatment.

Juvenile idiopathic arthritis (from 2 to less than 18 years of age)

The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 12 weeks of treatment.

Treatment initiation

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).

Dose reduction

In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors such as probenecid, or with creatinine clearance between 30 and 60 mL/min the recommended dose should be reduced by half for paediatric patients and the recommended dose is 2 mg for adult patients (see section 4.5).

Special populations

Renal impairment

The recommended dose is 2 mg once daily in adult patients with creatinine clearance between 30 and 60 mL/min. In paediatric patients with creatinine clearance between 30 and 60 mL/min, the recommended dose of baricitinib should be reduced by half. Baricitinib 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. Baricitinib is not recommended for use in patients with severe hepatic impairment (see section 5.2).

Elderly

Clinical experience in patients aged ≥75 years is very limited.

Paediatric population (less than 2 years)

The safety and efficacy of baricitinib in children less than 2 years have not yet been established. No data are available. See section 4.2 above for information on posology in children aged 2 years and older.

The safety and efficacy of baricitinib in children less than 18 years of age with alopecia areata have not yet been established. No data are available.

Method of administration

Oral use.

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

Alternative administration for children

For paediatric patients who are unable to swallow whole tablets, it may be considered to disperse the tablets in water. Only water should be used to disperse the tablet. Only the number of tablets needed for the dose should be dispersed.

If for any reason the entire suspension is not administered, do not disperse and administer another tablet but wait until the next scheduled dose.

For instructions on dispersion of the medicinal product before administration, see section 6.6.

Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered to adult patients in clinical trials without dose-limiting toxicity. 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.

3 years.

This medicinal product does not require any special storage conditions.

Olumiant 1 mg film-coated tablets:

Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium blisters in cartons of 14 or 28 film-coated tablets.

Polyvinylchloride/aluminium/oriented polyamide – aluminium perforated unit dose blisters in cartons of 28 × 1 film-coated tablets.

Olumiant 2 mg and 4 mg film-coated tablets:

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.

For paediatric patients who are unable to swallow whole tablets, it may be considered to disperse the tablets in water. Only water should be used to disperse the tablet. Only the number of tablets needed for the dose should be dispersed.

• Place whole tablet in a container with 5-10 mL of water at room temperature and gently swirl to disperse. It may take up to 10 minutes for the tablet to disperse into a cloudy pale pink suspension. Some settling may occur.
• After the tablet is dispersed, gently swirl again and administer the entire suspension immediately.
• Rinse the container with 5-10 mL of water at room temperature and administer the entire contents immediately.

The tablet dispersed in water is stable for up to 4 hours at room temperature. If for any reason the entire suspension is not administered, do not disperse and administer another tablet but wait until the next scheduled dose.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.