SIMPONI® recommended dosage for pediatric UC1
The recommended SIMPONI® subcutaneous dosage for pediatric patients weighing at least 15 kg with moderately to severely active UC is
based on body weight as shown in the table below:
| Pediatric Weight | Week 0 | Week 2 | Week 6 and every 4 weeks thereafter |
|---|---|---|---|
| 40 kg and greater | 200 mg | 100 mg | 100 mg |
| At least 15 kg to less than 40 kg | 100 mg | 50 mg | 50 mg |
- For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL)
Prior to initiating SIMPONI®, evaluate patients for active tuberculosis and test for latent infection, test patients for hepatitis B viral infection; and if possible, complete all age-appropriate vaccinations according to current immunization guidelines.
SIMPONI® is intended for use under the guidance and supervision of a healthcare provider. Pediatric patients 12 years of age and older may self-inject with SIMPONI® prefilled syringe, if a physician determines that it is appropriate, and after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use. Use of the SmartJect® autoinjector for pediatric self-administration has not been evaluated.
SIMPONI® requires nearly half the injections compared with
Humira® (adalimumab) (per first year of treatment)1,2
SIMPONI®*
INDUCTION
Week 0
1 or 2 injections
depending on
patient’s
body
weight
Week 2
MAINTENANCE
1 injection at Week 6 and every 4 weeks thereafter
14 OR 15
TOTAL INJECTIONS
PER FIRST YEAR†¶
Humira®*‡
INDUCTION
Day 1
1 or 2 injections
depending
on
patient’s body weight
Day 8
Day 15
MAINTENANCE
Starting on Day 29, 1 injection every
2 weeks
28 OR 29
TOTAL INJECTIONS
PER FIRST YEAR§II¶
OR
INDUCTION
Day 1
1 or 2 injections
depending
on
patient’s body weight
Day 8
Day 15
MAINTENANCE
Starting on Day 29, 1 injection every
week
52 OR 53
TOTAL INJECTIONS PER
FIRST YEAR§II¶
This presentation is not intended to compare the safety, efficacy, or indications of these treatments. While these factors are important, there are additional considerations for selecting a treatment. Please refer to each product’s Prescribing Information for additional information, including recommended dosing and administration.
SIMPONI® is administered by subcutaneous (SC) injection. The recommended dosage for pediatric patients weighing at least 15 kg with ulcerative colitis is based on body weight. For pediatric patients weighing 40 kg and greater, the recommended dosage is 200 mg at Week 0, 100 mg at Week 2, and 100 mg at Week 6 and every 4 weeks thereafter. For pediatric patients weighing at least 15 kg to less than 40 kg, the recommended dosage is 100 mg at Week 0, 50 mg at Week 2, and 50 mg at Week 6 and every 4 weeks thereafter.
Humira® is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Humira® is administered by SC injection and is based on patient's weight. For children weighing between 20 kg (44 lbs) to less than 40 kg (88 lbs), the recommended Day 1 dosage is 80 mg, the Day 8 dosage is 40 mg, the Day 15 dosage is 40 mg, and beginning on Day 29 the dosage is 20 mg every week or 40 mg every other week. For children weighing 40 kg (88 lbs) or greater, the recommended Day 1 dosage is 160 mg, the Day 8 dosage is 80 mg, the Day 15 dosage is 80 mg, and beginning on Day 29 the dosage is 40 mg every week or 80 mg every other week.
Humira is a registered trademark of AbbVie Inc.
*Trademarks are the property of their respective owners.
†
Calculations for total number of injections for the first year of treatment with SIMPONI® for pediatric patients with moderately to severely active ulcerative colitis are based on 1 to 2 injections (depending on the patient’s body weight) at Week 0 and 1 injection at Week 2 for the induction phase. Additionally, 1 injection at Week 6, followed by a maintenance dosing regimen of 1 injection every 4 weeks through 52 weeks of therapy equals a total of 14 or 15 injections for the first year of treatment.1
‡Humira® is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
§
Calculations for the total number of injections for the first year of treatment with Humira® for pediatric patients with moderately to severely active ulcerative colitis are based on recommended dosing for pediatric patients weighing between 20 kg (44 lbs) to less than 40 kg (88 lbs). For the induction phase, the recommended Day 1 dosage is 80 mg, the Day 8 dosage is 40 mg, the Day 15 dosage is 40 mg, and beginning on Day 29 the maintenance therapy is 20 mg every week or 40 mg every other week. For pediatric patients weighing 40 kg (88 lbs) or greater, the recommended Day 1 dosage is 160 mg, the Day 8 dosage is 80 mg, the Day 15 dosage is 80 mg, and beginning on Day 29, the maintenance therapy is 40 mg every week or 80 mg every other week. The total number of injections (including both induction and maintenance) during the first year of treatment for patients receiving 1 maintenance injection every 2 weeks is 28 or 29 injections. The total number of injections (including both induction and maintenance) during the first year of treatment for patients receiving 1 maintenance injection every week is 52 or 53 injections.2
||Number of Humira® induction injections calculated using 80-mg, 40-mg, and 20-mg formulations.
¶"Per first year" refers to Weeks 0 to 52.