Active Ingredient: Upadacitinib
Upadacitinib 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).
Upadacitinib is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 15 milligrams upadacitinib, once daily.
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.
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.
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 the following table.
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 |
There are limited data in patients 75 years of age and older.
Upadacitinib is to be taken orally once daily with or without food and may be taken at any time of the day.
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