- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
An oral dose of 1200 mg / m2 / day results in the same AUC values in children 2-18 years (n = 49) as an oral dose of 2 g / day in adults [SmPC Cellcept].
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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
| Prophylaxis for Graft versus Host Disease after allogenic stemcel transplant |
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| Atopic dermatitis |
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| Prophylaxis of rejection in heart and liver transplantation |
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| Prophylaxis for rejection of a transplanted kidney |
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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
In children (especially aged 2-6 years), the following are more common: diarrhoea, sepsis, leukopenia, anaemia and infection. In children 12-18 years of age anxiety and depressions are reported. (Arkin et al. 2016).
Certain side effects appear to occur more frequently in children younger than 6 years of age: lymphomas and other malignancies, particularly post-transplant lymphoproliferative disorders in heart transplant patients, disorders of the blood and lymphatic system, including anaemia and neutropenia in heart transplant patients, and gastrointestinal complaints.
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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
Monitoring in atopic eczema:
- Check creatinine, liver enzymes (ALT) and complete blood count at start of treatment.
- Monitor labvalues 1 month after start, 2 months after start and after each dose increase.
- Subsequently, at a stable dose, check every 3 months (if previous values were normal)
- The following recommendations apply for deviating lab values:
- Liver enzymes> 2x normal: reduce dose and monitor every 4-6 weeks. If> 3x normal value: temporarily stop and evaluate the lowest possible safe dosage on restart.
- For lymphocytes <1.0x109 / L and / or neutrophils <1.5x109 / L: reduce dose and consult a haematologist if necessary. Monitor weekly.
- Pay attention to vaccination advice during mycophenolic acid use.
- Pay attention to adequate contraception / desire to have children. Mycophenolic acid is contraindicated in pregnancy.
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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 | ||
| L04AA31 | ||
| L04AA04 | ||
| L04AA44 | ||
| Other immunosuppressants | ||
|---|---|---|
| L04AX01 | ||
| L04AX03 | ||
| Tumor necrosis factor alpha (TNF-alpha) inhibitors | ||
|---|---|---|
| L04AB04 | ||
| L04AB01 | ||
| L04AB06 | ||
| L04AB02 | ||
| 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
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Roche Registration Limited, SPC Cellcept (EU/1/96/005/001), www.ema.europa.eu, Geraadpleegd 10 juni 2010, http://www.ema.europa.eu/humandocs/PDFs/EPAR/Cellcept/emea-combined-h82nl.pdf
- 1A Pharma, SmPC Mycophenolat 250 mg Hartkapseln (67970.00.00), 12/2015
- Biomo, SmPC mycophenolatmofetil 250/500 mg Filmtabletten (80676.00.00 / 80677.00.00), 01/2018
- MMI, Online GL. Gelbe Liste Online, Accessed July 19, 2018
- Roche, SmPC CellCept® i.v. Infusionslösungskonzentrat (EU/1/96/005/005), 03/2018
- Roche, SmPC CellCept® orale Suspension (EU/1/96/005/006), 03/2018
- Roche, SmPC CellCept® 500 mg Filmtabletten (EU/1/96/005/002), 03/2018
- Roche, SmPC CellCept® 250 mg Kapseln (EU/1/96/005/001), 03/2018
- Arkin, L., et al, Mycophenolate Mofetil and Mood Changes in Children with Skin Disorders., Pediatr Dermatol, 2016, 33(3), e216-7
- Heller, M., et al, Mycophenolate mofetil for severe childhood atopic dermatitis: experience in 14 patients, Br J Dermatol, 2007, 157(1), 127-32
- Sidbury, R., et al, Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents, J Am Acad Dermatol, 2014, 71(2), 327-49
- Waxweiler, W. T., et al, Systemic treatment of pediatric atopic dermatitis with azathioprine and mycophenolate mofetil., Pediatr Dermatol, 2011, 28(6), 689-94
- Nederlandse Vereniging voor Dermatologie en Venerelogie, Richtlijn constitutioneel eczeem., https://nvdv.nl/professionals/richtlijnen-en-onderzoek/richtlijnen/richtlijn-constitutioneel-eczeem, 2019
- Roche, SmPC CellCept® orale Suspension (EU/1/96/005/006), 03/2018
- Roche Registration GmbH, SmPC Cellcept (EU/1/96/005/001) Rev 40; 17-02-2025, www.ema.europa.eu
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Changes
Changes
