Ulcerative colitis

Active Ingredient: Risankizumab

Indication for Risankizumab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

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

For this indication, competent medicine agencies globally authorize below treatments:

1,200 mg administered by intravenous infusion at week 0, week 4, and week 8, followed by 180 or 360 mg administered by subcutaneous injection at week 12, and every 8 weeks thereafter

For:

Dosage regimens

Regimen A: Intravenous, 1,200 milligrams risankizumab, once every 4 weeks, 3 doses in total, over the duration of 12 weeks. Afterwards, in case that there is very good treatment response, subcutaneous, 180 milligrams risankizumab, once every 8 weeks.

Regimen B: Intravenous, 1,200 milligrams risankizumab, once every 4 weeks, 3 doses in total, over the duration of 12 weeks. Afterwards, in case that there is poor response to treatment, subcutaneous, 360 milligrams risankizumab, once every 8 weeks.

Detailed description

The recommended induction dose is 1 200 mg administered by intravenous infusion at week 0, week 4, and week 8. Starting at week 12 and every 8 weeks thereafter, the recommended maintenance dose is based on individual patient presentation:

  • A dose of 180 mg administered by subcutaneous injection is recommended for patients with adequate improvement in disease activity after induction.
  • A dose of 360 mg administered by subcutaneous injection is recommended for patients with inadequate improvement in disease activity after induction.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.

Dosage considerations

Intravenous infusion: The 1 200 mg dose should be administered over at least two hours.

Subcutaneous injection: The injection should be administered in the thigh or abdomen. Risankizumab should not be injected into areas where the skin is tender, bruised, erythematous, indurated or damaged.

Active ingredient

Risankizumab

Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor complex. IL-23 is a cytokine that is involved in inflammatory and immune responses. By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.

Read more about Risankizumab

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