Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
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.
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.
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients 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).
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
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.
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.
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.
Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which upadacitinib is indicated.
The recommended dose of upadacitinib is 15 mg once daily.
Consideration should be given to discontinuing treatment in patients with axial spondyloarthritis who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
The recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.
For patients 65 years of age and older, the recommended dose is 15 mg once daily (see section 4.4).
The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 30 kg.
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.
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). Upadacitinib should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation:
For patients 65 years of age and older, the recommended dose is 15 mg once daily (see section 4.4).
In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
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.
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation:
For patients 65 years of age and older, the recommended maintenance dose is 15 mg once daily (see section 4.4).
In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
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).
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is <0.5 × 109 cells/L, an absolute neutrophil count (ANC) that is <1 × 109 cells/L or who have haemoglobin (Hb) levels that are <8 g/dL (see sections 4.4 and 4.8).
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.
Table 1. Laboratory measures and monitoring guidance:
| Laboratory measure | Action | Monitoring guidance |
|---|---|---|
| Absolute Neutrophil Count (ANC) | Treatment should be interrupted if ANC is <1 × 109 cells/L and may be restarted once ANC returns above this value | Evaluate at baseline and then no later than 12 weeks after initiation of treatment. Thereafter evaluate according to individual patient management. |
| Absolute Lymphocyte Count (ALC) | Treatment should be interrupted if ALC is <0.5 × 109 cells/L and may be restarted once ALC returns above this value | |
| Haemoglobin (Hb) | Treatment should be interrupted if Hb is <8 g/dL and may be restarted once Hb returns above this value | |
| Hepatic transaminases | Treatment should be temporarily interrupted if drug- induced liver injury is suspected | Evaluate at baseline and thereafter according to routine patient management. |
| Lipids | Patients should be managed according to international clinical guidelines for hyperlipidaemia | Evaluate 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia |
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis:
There are limited data in patients 75 years of age and older.
Atopic dermatitis:
For atopic dermatitis, doses higher than 15 mg once daily are not recommended in patients 65 years of age and older (see section 4.8).
Ulcerative colitis and Crohn’s disease:
For ulcerative colitis and Crohn’s disease, doses higher than 15 mg once daily for maintenance therapy are not recommended in patients 65 years of age and older (see section 4.8). The safety and efficacy of upadacitinib in patients 75 years of age and older have not yet been established.
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). Upadacitinib should be used with caution in patients with severe renal impairment as described in Table 2. The use of upadacitinib has not been studied in subjects with end stage renal disease and is therefore not recommended for use in these patients.
Table 2. Recommended dose for severe renal impairmenta:
| Therapeutic indication | Recommended once daily dose |
|---|---|
| Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis | 15 mg |
| Ulcerative colitis, Crohn’s disease | Induction: 30 mg |
| Maintenance: 15 mg |
a estimated glomerular filtration rate (eGFR) 15 to <30 ml/min/1.73m²
No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment (see section 5.2). Upadacitinib should not be used in patients with severe (Child-Pugh C) hepatic impairment (see section 4.3).
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).
The safety and efficacy of RINVOQ in children and adolescents with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and Crohn’s disease, aged 0 to less than 18 years have not yet been established. No data are available.
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.
Upadacitinib was administered in clinical studies up to doses equivalent in daily AUC to 60 mg prolonged-release once daily. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). 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.
RINVOQ 15 mg prolonged-release tablets:
Prolonged-release tablets in blisters: 2 years.
Prolonged-release tablets in bottles: 3 years.
RINVOQ 30 mg prolonged-release tablets:
Prolonged-release tablets in blisters: 2 years.
Prolonged-release tablets in bottles: 3 years.
RINVOQ 45 mg prolonged-release tablets:
2 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original blister or bottle in order to protect from moisture. Keep the bottle tightly closed.
RINVOQ 15 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolonged- release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Not all pack sizes may be marketed.
RINVOQ 30 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Not all pack sizes may be marketed.
RINVOQ 45 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 prolonged-release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 28 prolonged-release tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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