- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The median steady state exposure in children aged 6-17 yrs was 20% lower than in adults. In children aged 2-6, it was as much as 40% lower [SmPC]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Inflammatory bowel disease (IBD), sarcoid-related uveitis, juvenile Idiopathic arthritis (JIA), hereditary autoinflammatory conditions including Blau syndrome |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
General: infusion reactions, antibodies against infliximab, infections.
In Crohn's disease: anaemia, blood in the faeces, leukopenia, flushing, viral/bacterial infections, neutropenia and allergic reactions of the airways have been reported more often in children.In the study, bone fractures were reported more frequently in children, but a causal link with the use of infliximab has not been established.
In ulcerative colitis: upper respiratory tract infections, pharyngitis, abdominal pain, fever and headache are commonest in children.
(SmPC Remicade)
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
The risk of malignancies or hepatosplenic T-cell lymphoma developing in children and adolescents who have been treated with TNF blockers cannot be excluded.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Selective immunosuppressants | ||
|---|---|---|
| L04AA24 | ||
| L04AA32 | ||
| L04AA13 | ||
| L04AA02 | ||
| L04AA06 | ||
| L04AA31 | ||
| L04AA04 | ||
| L04AA44 | ||
| Other immunosuppressants | ||
|---|---|---|
| L04AX01 | ||
| L04AX03 | ||
| Tumor necrosis factor alpha (TNF-alpha) inhibitors | ||
|---|---|---|
| L04AB04 | ||
| L04AB01 | ||
| L04AB06 | ||
| Interleukin inhibitors | ||
|---|---|---|
| L04AC03 | ||
| L04AC02 | ||
| L04AC08 | ||
| L04AC13 | ||
| L04AC19 | ||
| L04AC10 | ||
| L04AC22 | ||
| L04AC07 | ||
| L04AC05 | ||
| Calcineurin inhibitors | ||
|---|---|---|
| L04AD01 | ||
| L04AD02 | ||
| Sphingosine-1-phosphate (S1P) receptor modulators | ||
|---|---|---|
| L04AE01 | ||
| Janus-associated kinase (JAK) inhibitors | ||
|---|---|---|
| L04AF02 | ||
| L04AF02 | ||
| L04AF08 | ||
| L04AF01 | ||
| Monoclonal antibodies | ||
|---|---|---|
| L04AG04 | ||
| Mammalian target of rapamycin (mTOR) kinase inhibitors | ||
|---|---|---|
| L04AH02 | ||
| L04AH01 | ||
| Complement inhibitors | ||
|---|---|---|
| L04AJ01 | ||
| L04AJ02 | ||
| Dihydroorotate dehydrogenase (DHODH) inhibitors | ||
|---|---|---|
| L04AK02 | ||
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References
- Centocor BV, SPC Remicade (EU/1/99/116/001-005) 12-12-2018, www.ema.europa.eu
- Nederlandse Vereniging voor Kindergeneeskunde, CBO Richtlijn Diagnostiek en behandeling van Inflammatoire darmziekten bij Kinderen,, 2008, 111-116
- Beresford MW et al., New advances in the management of juvenile idiopathic arthritis--2: the era of biologicals., Arch Dis Child Educ Pract Ed., 2009, Oct;94(5), 151-6
- Kahn P et al., Favorable response to high-dose infliximab for refractory childhood uveitis., Ophthalmology., 2006, May;113(5):, 860-4.e2
- Lahdenne P et al., Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: an open label study., Ann Rheum Dis., 2003, Mar;62(3), 245-7
- Levälampi T et al., Effects of infliximab on cytokines, myeloperoxidase, and soluble adhesion molecules in patients with juvenile idiopathic arthritis., Scand J Rheumatol., 2007, May-Jun;36(3), 189-93
- Milman N et al. , Favourable effect of TNF-alpha inhibitor (infliximab) on Blau syndrome in monozygotic twins with a de novo CARD15 mutation. , APMIS. , 2006 , Dec;114(12), 912-9
- Petiti Martin G et al., Misdiagnosed childhood sarcoidosis as non-Langerhans' cell histiocytosis treated with tumor necrosis factors-? antagonists., An Pediatr (Barc)., 2012, Oct;77(4), 267-71
- Ruperto N et al., A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis., Arthritis Rheum., 2007, Sep;56(9), 3096-106
- Ruperto N et al. , Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension. , Ann Rheum Dis., 2010, Apr;69(4), 718-22
- Simonini G et al., Prevention of flare recurrences in childhood-refractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab., Arthritis Care Res (Hoboken)., 2011, Apr;63(4), 612-8
- Tynjälä P et al., Drug survival of the first and second course of anti-tumour necrosis factor agents in juvenile idiopathic arthritis., Ann Rheum Dis., 2009, Apr;68(4), 552-7
- Pfizer, SmPC Inflectra 100 mg Pulver zur Herstellung einer Infusionslösung (EU/1/13/854/001, EU/1/13/854/002,EU/1/13/854/003, EU/1/13/854/004, EU/1/13/854/005), 02/2018
- MSD, SmPC Remicade 100mg Pulver zur Herstellung einer Infusionslösung (EU/1/99/116/001;EU/1/99/116/002;EU/1/99/116/003;EU/1/99/116/004;EU/1/99/116/005), 03/2018
- DAZ.online, Individuell für Kinder, Accessed May 14, 2018
- Breitkreutz J and Boos J, Paediatric and geriatric drug delivery. - PubMed - NCBI, Accessed May 14, 2018
- Jongsma, M. M. E., et al., First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial., Gut, 2020, Online ahead of print
- van Rheenen, P. F., et al., The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update, J Crohns Colitis, 2020, Online ahead of print.
- Walters, T. D., et al., Increased effectiveness of early therapy with anti-tumor necrosis factor-α vs an immunomodulator in children with Crohn's disease, Gastroenterology, 2014, 146(2), 383-91
- Lee, Y. M., et al., Infliximab "Top-Down" Strategy is Superior to "Step-Up" in Maintaining Long-Term Remission in the Treatment of Pediatric Crohn Disease, J Pediatr Gastroenterol Nutr, 2015, 60(6), 737-43
- Kang, B., et al., Mucosal Healing in Paediatric Patients with Moderate-to-Severe Luminal Crohn's Disease Under Combined Immunosuppression: Escalation versus Early Treatment., J Crohns Coliti, 2016, s10 (11), 1279-1286
- Jongsma, M. M. E., et al., Infliximab in young paediatric IBD patients: it is all about the dosing, Eur J Pediatr, 2020, 179 (12), 1935-44
- Winter, D. A., et al., Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Infliximab in Pediatric Inflammatory Bowel Disease: A Systematic Review and Revised Dosing Considerations., J Pediatr Gastroenterol Nutr, 2020, 70(6), 763-776
- Milman N et al., Favourable effect of TNF-alpha inhibitor (infliximab) on Blau syndrome in monozygotic twins with a de novo CARD15 mutation., APMIS., 2006, Dec;114(12), 912-9
- MSD, SmPC Remicade 100mg Pulver zur Herstellung einer Infusionslösung (EU/1/99/116/001;EU/1/99/116/002;EU/1/99/116/003;EU/1/99/116/004;EU/1/99/116/005), 03/2018
- Ruperto N et al., Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension., Ann Rheum Dis., 2010, Apr;69(4), 718-22
- Centocor BV, SmPC Remicade (EU/1/99/116/001-005)Rev 68; 16-05-2025, www.ema.europa.eu
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Changes
Changes
