OLUMIANT FILM-COATED TABLET 2MG [SIN15504P]

Product Info

OLUMIANT FILM-COATED TABLET 2MG

[SIN15504P]

Indication

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 (DMARDs). 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

Adults
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.

Children and adolescents (2 years of age and older)
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in paediatric patients 2 years of age and older whose disease is not adequately controlled with conventional topical and systemic 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).

Juvenile idiopathic arthritis

Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:

• Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),

• Enthesitis related arthritis, and

• Juvenile psoriatic arthritis.

Baricitinib may be used as monotherapy or in combination with methotrexate.

Dosing

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 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 2mg once daily should 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

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

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

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 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).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). An appropriate dose strength is not available for children weighing less than 30 kg taking OAT3 inhibitors or with moderate renal impairment. Do not exceed 1 mg once daily for these patients.

Special Populations
Renal impairment
The recommended dose is 2mg 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). An appropriate dose strength is not available for children weighing less than 30 kg taking OAT3 inhibitors or with moderate renal impairment. Do not exceed 1 mg once daily for these patients.

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

Contraindications

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).