Active Ingredient: Upadacitinib
Upadacitinib 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that there is very good treatment response, oral, 45 milligrams upadacitinib, once daily, over the duration of 8 weeks. Afterwards, in case that there is very good treatment response, oral, 15 milligrams upadacitinib, once daily.
Regimen B: In case that there is very good treatment response, oral, 45 milligrams upadacitinib, once daily, over the duration of 8 weeks. Afterwards, in case that there is poor response to treatment, oral, 30 milligrams upadacitinib, once daily.
Regimen C: In case that there is poor response to treatment, oral, 45 milligrams upadacitinib, once daily, over the duration of 8 to 16 weeks. Afterwards, in case that there is poor response to treatment, oral, 15 milligrams upadacitinib, once daily.
Regimen D: In case that there is poor response to treatment, oral, 45 milligrams upadacitinib, once daily, over the duration of 8 to 16 weeks. Afterwards, in case that there is poor response to treatment, oral, 30 milligrams upadacitinib, once daily.
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. 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:
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 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.
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 |
Upadacitinib is to be taken orally once daily with or without food and may be taken at any time of the day.
For:
Oral, 45 milligrams upadacitinib, once daily, over the duration of 8 to 16 weeks. Afterwards, oral, 15 milligrams upadacitinib, once daily.
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. Upadacitinib should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
For patients 65 years of age and older, the recommended dose is 15 mg once daily. The safety and efficacy of upadacitinib in patients 75 years of age and older have not yet been established.
In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
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 |
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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