Active Ingredient: Ustekinumab
Ustekinumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
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, 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, subcutaneous, 90 milligrams ustekinumab, once every 8 to 12 weeks.
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.
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