HUMIRA for Moderate to Severe Pediatric Ulcerative Colitis (UC)
HUMIRA for Moderate to Severe Pediatric Ulcerative Colitis (UC)
What is HUMIRA?
HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
HUMIRA Results for Pediatric Ulcerative Colitis
The goal of pediatric ulcerative colitis (UC) treatment is remission- few or no symptoms. With HUMIRA, remission is possible for children 5 years of age and older.
A majority of patients
ACHIEVED REMISSION
at 8 weeks
In a clinical study among pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis, a majority of patients on HUMIRA achieved remission after just 8 weeks.*
Many responding to treatment
WERE IN REMISSION
at 1 year
Many children who responded to treatment by week 8 were in remission at 1 year. Additionally, a majority of children responding by week 8 continued to have symptom relief at 1 year.*
*Individual results may vary.
A majority of patients
ACHIEVED REMISSION
at 8 weeks
Many responding to treatment
WERE IN REMISSION
at 1 year
In a clinical study among pediatric patients from 5 to 17 years of age with moderate to severe ulcerative colitis, a majority of patients on HUMIRA achieved remission after just 8 weeks.*
Many children who responded to treatment by week 8 were in remission at 1 year. Additionally, a majority of children responding by week 8 continued to have symptom relief at 1 year.*
*Individual results may vary.
Common side effects of HUMIRA
Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your child's doctor if your child has any side effect that bothers them or that does not go away.
Read about the Important Safety Information for HUMIRA.
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HUMIRA Dosing for Pediatric Ulcerative Colitis
Important: You must pay attention to your child’s starting dose—it is different from his or her maintenance dose and is a critical part of taking HUMIRA after as prescribed†. Dosing varies depending on your child's body weight. Always follow the doctor's instructions about when and how often your child should take HUMIRA.
Starting Dose
Administered on Day 1, Day 8, and Day 15
Maintenance Dose
Can be administered at home either every week or every other week starting on Day 29
Your child’s first dose of HUMIRA must be given under the supervision of a health care professional. Make sure you have been shown how to administer HUMIRA before you give the treatment to your child. Remember to keep your HUMIRA refrigerated in its original container until ready for use.
Getting started with HUMIRA dosing
Recommended dosing for pediatric UC patients 5 years of age and older varies depending on your child’s weight.† Always follow the doctor’s instructions about when and how often your child should take HUMIRA.
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 more, 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 given by an injection under the skin.
Your child should continue taking HUMIRA as directed by your child’s doctor. Remember, HUMIRA is a treatment, not a cure. Your child’s doctor can tell you if and when your child should stop taking HUMIRA.
For more information, refer to the Patient Instructions for Use and the Medication Guide located inside the HUMIRA carton, and within the Full Prescribing Information. If your child experiences any adverse reactions or discomfort when taking HUMIRA, discuss them with your child's doctor right away.
Pediatric patients who turn 18 years of age and are well-controlled on their HUMIRA regimen should continue their prescribed dose.
†Refer to the Patient Instructions for Use to learn about the HUMIRA Pen and prefilled syringe.
‡Can be given as a single dose in one day or split over 2 consecutive days.
How does HUMIRA work?
The protein TNF-alpha is believed to be part of your body’s natural processes involved in creating inflammation, and in some cases, excess inflammation. When used as prescribed, HUMIRA targets and blocks TNF-alpha, which can help reduce excess inflammation associated with pediatric ulcerative colitis.
Already prescribed HUMIRA?
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