Ulcerative colitis

Active Ingredient: Guselkumab

Indication for Guselkumab

Population group: only adults (18 years old or older)

Therapeutic intent: Curative procedure

Guselkumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

200 mg at Week 0, 4 and 8, and thereafter 100 mg at Week 16 and every 8 weeks or 200 mg at Week 12 and every 4 weeks

For:

Dosage regimens

Regimen A: Intravenous, 200 milligrams guselkumab, once every 4 weeks, 3 doses in total, over the duration of 16 weeks. Afterwards, intravenous, 100 milligrams guselkumab, once every 8 weeks.

Regimen B: Intravenous, 200 milligrams guselkumab, once every 4 weeks.

Detailed description

Induction

The recommended induction dosage is 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8.

Maintenance

The recommended maintenance dosage of guselkumab is:

100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.

Use the lowest effective recommended dosage to maintain therapeutic response.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Dosage considerations

Do not infuse guselkumab concomitantly in the same intravenous line with other medicinal products.

Active ingredient

Guselkumab
Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity. IL-23 is a cytokine that is involved in inflammatory and immune responses. By blocking IL-23 from binding to its receptor, guselkumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines. Read more about Guselkumab

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