Active Ingredient: Guselkumab
Guselkumab 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 treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 200 milligrams guselkumab, once every 4 weeks, 3 doses in total, over the duration of 16 weeks. Afterwards, subcutaneous, 100 milligrams guselkumab, once every 8 weeks.
Regimen B: Intravenous, 200 milligrams guselkumab, once every 4 weeks, 3 doses in total, over the duration of 16 weeks. Afterwards, subcutaneous, 200 milligrams guselkumab, once every 4 weeks.
The recommended induction dose is 200 mg administered by intravenous infusion at Week 0, Week 4 and Week 8.
After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered.
Immunomodulators and/or corticosteroids may be continued during treatment with guselkumab. In patients who have responded to treatment with guselkumab, corticosteroids may be reduced or discontinued in accordance with standard of care.
Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit after 24 weeks of treatment.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
No dose adjustment is required.
There is limited information in patients aged ≥65 years and very limited information in patients aged ≥75 years.
Sites for subcutaneous injection include the abdomen, thigh and back of the upper arm. Guselkumab should not be injected into areas where the skin is tender, bruised, red, hard, thick or scaly. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.