RINVOQ EXTENDED-RELEASE TABLET 15MG [SIN15959P]

Product Info

RINVOQ EXTENDED-RELEASE TABLET 15MG

[SIN15959P]

4.1 Therapeutic indications

Rheumatoid Arthritis

RINVOQ 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). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic Arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Non-radiographic Axial Spondyloarthritis

RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing Spondylitis

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic Dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy and whose disease is not adequately controlled with topical medications or for whom topical treatments are otherwise medically inadvisable.

Ulcerative Colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Crohn’s Disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

4.2 Posology and method of administration

Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which upadacitinib is indicated.

Posology

Rheumatoid Arthritis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis

The recommended dose of upadacitinib is 15 mg once daily.

Atopic Dermatitis

Adults

The recommended dose of upadacitinib is 15 mg once daily for adults.

A dose of 30 mg once daily may be considered for patients with high disease burden or for patients with an inadequate response to 15 mg once daily, if clinically warranted and based on benefit-risk assessment.

The lowest effective dose for maintenance should be used.

For patients ≥ 65 years of age, the recommended dose of upadacitinib is 15 mg once daily.

Adolescents (from 12 to 17 years of age)

The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 30 kg.

Concomitant Topical Therapies

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

Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment.

Ulcerative Colitis

Induction

The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks. For patients who do not achieve adequate therapeutic benefit by Week 8, upadacitinib 45 mg once daily may be continued for an additional 8 weeks (see sections 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Upadacitinib should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.

Maintenance

The recommended maintenance dose of upadacitinib is 15 mg or 30mg once daily based on individual patient presentation:

• A dose of 30 mg once daily may be appropriate for some patients, such as those with high disease burden (e.g. severe disease, pancolitis) or requiring 16-week induction treatment.

• A dose of 30 mg once daily may be appropriate for patients who do not show adequate therapeutic benefit to 15 mg once daily.

• The lowest effective dose for maintenance should be used.

For patients ≥ 65 years of age, the recommended maintenance dose is 15 mg once daily.

In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

Crohn’s Disease

Induction

The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks. For patients who have not achieved adequate therapeutic benefit after the initial 12-week induction, prolonged induction for an additional 12 weeks with a dose of 30 mg once daily may be considered. For these patients, upadacitinib should be discontinued if there is no evidence of therapeutic benefit after 24 weeks of treatment.

Maintenance

The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation:

• A dose of 30 mg once daily may be appropriate for patients with high disease burden or who do not show adequate therapeutic benefit to 15 mg once daily.

• The lowest effective dose to maintain response should be used.

For patients 65 years of age and older, the recommended maintenance dose is 15 mg once daily.

In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

Interactions

For patients with ulcerative colitis and Crohn’s disease receiving strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole, clarithromycin), the recommended induction dose is 30 mg once daily and the recommended maintenance dose is 15 mg once daily (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose Initiation

Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 0.5 x 10⁹ cells/L, an absolute neutrophil count (ANC) that is < 1 x 10⁹ cells/L or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose Interruption

Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.

Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.

Special Populations

Elderly

For atopic dermatitis, doses higher than 15 mg once daily are not recommended in patients aged 65 years and older (see Section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For ulcerative colitis and Crohn's disease, doses higher than 15 mg once daily for maintenance therapy are not recommended in patients aged 65 years and older (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and efficacy of upadacitinib in patients aged 75 and older have not yet been established.

There are limited data in patients aged 75 years and older.

Renal Impairment

No dose adjustment is required in patients with mild or moderate renal impairment. There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Upadacitinib should be used with caution in patients with severe renal impairment (estimated glomerular filtration rate (eGFR) 15 to < 30 ml/min/1.73m²) as described in Table 2. The use of upadacitinib has not been studied in subjects with end stage renal disease.

Hepatic Impairment

No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Upadacitinib should not be used in patients with severe (Child Pugh-C) hepatic impairment (see section 4.3).

Paediatric Population

Atopic Dermatitis

The safety and efficacy of RINVOQ in children with atopic dermatitis below the age of 12 years have not been established. No data are available. No clinical exposure data are available in adolescents < 40 kg (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Rheumatoid Arthritis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn’s Disease

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

Method of Administration

RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the day. Tablets should be swallowed whole and should not be split, crushed, or chewed in order to ensure the entire dose is delivered correctly.

Missed Dose

If a dose of RINVOQ is missed and it is more than 10 hours from the next scheduled dose, advise the patient to take a dose as soon as possible and then to take the next dose at the usual time. If a dose is missed and it is less than 10 hours from the next scheduled dose, advise the patient to skip the missed dose and take only a single dose as usual the following day. Advise the patient not to double a dose to make up for a missed dose.

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.

• Active tuberculosis (TB) or active serious infections (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe hepatic impairment (see section 4.2).

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