Ulcerative colitis

Active Ingredient: Ustekinumab

Indication for Ustekinumab

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

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

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

260-520 mg initial intravenous dose once based on body weight, 90 mg subcutaneous dose at week 8 and thereafter every 8-12 weeks

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 55 kg, intravenous, 260 milligrams ustekinumab, one dose, over the duration of 8 weeks. Afterwards, in case that patient weight is ≤ 55 kg, subcutaneous, 90 milligrams ustekinumab, once every 8 to 12 weeks.

Regimen B: In case that patient weight is ≥ 55 kg and patient weight is ≤ 85 kg, intravenous, 390 milligrams ustekinumab, one dose, over the duration of 8 weeks. Afterwards, in case that patient weight is ≥ 55 kg and patient weight is ≤ 85 kg, subcutaneous, 90 milligrams ustekinumab, once every 8 to 12 weeks.

Regimen C: In case that patient weight is ≥ 85 kg, intravenous, 520 milligrams ustekinumab, one dose, over the duration of 8 weeks. Afterwards, in case that patient weight is ≥ 85 kg, intravenous, 90 milligrams ustekinumab, once every 8 to 12 weeks.

Detailed description

Ustekinumab treatment is to be initiated with a single intravenous dose based on body weight.

Initial intravenous dosing of ustekinumab:

Body weight of patient at the
time of dosing
Recommended dosea
≤55 kg 260 mg
>55 kg to ≤85 kg 390 mg
>85 kg 520 mg

a Approximately 6 mg/kg.

The first subcutaneous administration of 90 mg ustekinumab should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended.

Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time.

Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks.

Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment.

Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose.

Immunomodulators and/or corticosteroids may be continued during treatment with ustekinumab. In patients who have responded to treatment with ustekinumab, corticosteroids may be reduced or discontinued in accordance with standard of care.

In Crohn’s disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.

Active ingredient

Ustekinumab

Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Read more about Ustekinumab

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