Active Ingredient: Upadacitinib
Upadacitinib is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient weight is ≥ 30 kg :
Oral, 15 milligrams upadacitinib, once daily, over the duration of up to 24 weeks.
Regimen B, in the case that patient weight is ≥ 30 kg :
Oral, 30 milligrams upadacitinib, once daily, over the duration of up to 24 weeks.
For adults and adolescent patients 12 years of age and older weighing at least 30 kg, the recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.
Efficacy data are available for 24 weeks of treatment. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.
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.
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 x 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 x 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 |
For:
Oral, 15 milligrams upadacitinib, once daily.
For patients 65 years of age and older, the recommended dose is 15 mg once daily.
The safety and efficacy of upadacitinib in patients 65 years of age and older have not yet been established.
Efficacy data are available for 24 weeks of treatment. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.
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.
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 x 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 x 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 |
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