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Unit 2E Stollery Children's Hospital

8440 112 St NW, Edmonton, AB T6G 2B7

pedsibd@ualberta.ca

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Biologics

OVERVIEW: The term biologics refers to medications that are made from cells in the lab. Typically, they are more sophisticated and expensive but are tailored to effectively change a biological response in the body. Antibodies made against TNF-alpha (a major mediator of inflammation in IBD; also known as anti-TNF antibodies) are the only biologics currently licenced for use in children but we expect others to be available soon. These block the action of TNF in the body, which helps to suppress your immune system helping to reduce the inflammation within your body. Two brands of drug are mostly used in children: Remicade and Humira

WHEN DO WE USE IT: Biologics are used for treating both Crohn Disease and Ulcerative Colitis.

DURATION OF TREATMENT: Biologics are used long term. 

 

NOTE: ALTHOUGH HERE WE ONLY DISCUSS INFLIXIMAB AND HUMIRA, THERE ARE OTHER BIOLOGICS TESTED IN ADULTS THAT MAY BE USED IN PEDIATRIC IBD PATIENTS IF NEEDED. YOUR DOCTOR CAN TELL YOU MORE ABOUT THEM.

Remicade (Infliximab)

HOW IT'S USED:

  • Given intravenously

  • Initially get 3 doses called “loading doses”: given at 0, 2 and 6 weeks

  • Maintenance doses are given every 8 weeks.

  • Some patients require that their doses be given earlier than 8 weeks.  Some patients require infusions every 4 weeks. This is determined by recurrence of symptoms and/or therapeutic drug monitoring results (drug levels).

 

WHERE DO I GET MY TREATMENT: Infusions given at 2D Stollery Clinic, Campus Towers Infusion Clinic (for patients 14 years and older) or at rural infusion centres

Humira (Adalimumab)
 

HOW IT'S USED:

  • Given as a subcutaneous injection (in the fat of the stomach or thigh)

  • Loading doses: usually 160 mg (4 injections) then 2 weeks later 80 mg (2 injections)

  • Maintenance dose: usually 40 mg (1 injection every 2 weeks), dose/frequency may change

 

WHERE DO I GET MY TREATMENT

  • First dose is given with your IBD nurse

  • IBD nurse will teach patient and caregiver how to give the injection from home

  • Support can be provided in the home with the injections through “Abbvie Care”, a third party patient support program. More information can be provided from your health care team

SIDE EFFECTS OF REMICADE AND HUMIRA

 

Most patients tolerate their treatments very well.  Some documented side effects that have occurred (but not commonly) are :

  • Abdominal pain, nausea, vomiting & diarrhea

  • Back pain, aching joints

  • Rash, flushing, dizziness

  • Headaches

  • Upper respiratory tract infections

  • Increased risk of infection: any infection or fever should be taken very seriously and reviewed by your doctor

  • Injection site reactions

  • Rare side effects

  • Allergic reactions: usually becomes apparent during the infusion, but some reports have indicated that allergic reactions can occur up to 12 days later.  Symptoms may include hives, difficulty breathing and swallowing, chest pain, headaches or lightheadedness

  • Nervous System: there have been rare reports of some patients developing disorders that affect the nervous system (changes in vision, weakness in arms and/or leg and numbness or tingling)

  • Heart: inform your doctor if you have congestive heart failure

  • Malignancy: very small increased risk of developing cancer, in particular lymphoma.

 

Support Programs Available to help remember when your infusion or injection is:

  • Humira App available for free on ITunes

  • Infliximab: IBD support App available for free on Itunes

References

1. www.remicade.com

2. Humira Product Monograph: July 10, 2012

3. Crohn’s and Colitis Foundation of Canada: Prescriptions for Health: October 2008