Active Ingredient: Golimumab
Golimumab is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient weight is ≥ 80 kg :
Subcutaneous, 200 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 100 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 100 milligrams golimumab, once every 4 weeks.
Regimen B, in the case that patient weight is ≥ 40 kg and patient weight is < 80 kg :
Subcutaneous, 200 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 100 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 100 milligrams golimumab, once every 4 weeks, over the duration of 52 weeks. Afterwards, subcutaneous, between 50 milligrams golimumab and 100 milligrams golimumab, once every 4 weeks.
Regimen C, in the case that patient weight is ≥ 15 kg and patient weight is < 40 kg :
Subcutaneous, 100 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 50 milligrams golimumab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 50 milligrams golimumab, once every 4 weeks, over the duration of 52 weeks. Afterwards, subcutaneous, between 25 milligrams golimumab and 50 milligrams golimumab, once every 4 weeks.
The recommended dose of golimumab for patients from 2 to 17 years of age with ulcerative colitis is based on body weight. Golimumab is administered via subcutaneous injection.
Golimumab dose for paediatric patients with ulcerative colitis:
| Patient weight | Induction Dose | Maintenance Dose Starting at Week 6 | Optional Maintenance Dose reduction* |
| ≥80 kg | • 200 mg at week 0 and • 100 mg at week 2 | • 100 mg every four weeks | Not applicable |
| ≥40 kg to <80 kg | • 200 mg at week 0 and • 100 mg at week 2 | • 100 mg every four weeks | • 50 mg every four weeks |
| ≥15 kg to <40 kg | • 100 mg at week 0 and • 50 mg at week 2 | • 50 mg every four weeks | • 25 mg every four weeks |
* The physician may consider decreasing the maintenance dose for patients who are in remission at or after week 54.
Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
If a patient forgets to inject golimumab on the planned date, the forgotten dose should be injected as soon as the patient remembers. Patients should be instructed not to inject a double dose to make up for the forgotten dose.
The next dose should be administered based on the following guidance:
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