OLUMIANT FILM-COATED TABLET 4MG [SIN15505P]

Product Info

OLUMIANT FILM-COATED TABLET 4MG

[SIN15505P]

4.1 Therapeutic indications
Rheumatoid arthritis
Baricitinib 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. Baricitinib 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Atopic dermatitis
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Alopecia areata
Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
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 4mg once daily. A dose of 2mg 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 2mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4mg once daily and are eligible for dose tapering (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Atopic dermatitis
The recommended dose of baricitinib is 2mg once daily. A dose of 4 mg once daily may be considered for patients who have not achieved sustained control of disease activity with 2 mg once daily. Dose tapering to a dose of 2mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4mg once daily and are eligible for dose tapering (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 with 4mg.

Alopecia areata
The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily may be appropriate for patients such as those aged ≥ 65 years and 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Treatment initiation
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 10⁹ cells/L, an absolute neutrophil count (ANC) less than 1 x 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Special Populations
Renal impairment
The recommended dose is 2mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Baricitinib is not recommended for use in patients with creatinine clearance < 30 mL/min (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

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

Paediatric population
The safety and efficacy of baricitinib in children and adolescents aged 0 to 18 years 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.

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