Mycophenolate mofetil

Generic name
Mycophenolate mofetil
Brand name
ATC Code
L04AA06
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Mycophenolate mofetil

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].

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Prophylaxis for Graft versus Host Disease after allogenic stemcel transplant
  • Intravenous
    • 1 month up to 12 years
      • 45 mg/kg/day in 3 doses.

      • According to the SCT protocol of Duke University and the University of Minnesota (USA)

    • 12 years up to 18 years
      • 30 mg/kg/day in 2 doses.

      • According to the SCT protocol of Duke University and the University of Minnesota (USA)
Atopic dermatitis
  • Oral
    • 2 years up to 18 years
      • Initial dose: 20 - 40 mg/kg/day in 2 doses.
      • Maintenance dose: 30 - 50 mg/kg/day in 2 doses.
        • A starting dose at the upper end of the dose range is recommended in young children
        • If no improvement occurs within 3 months of treatment using the highest tolerated dose, discontinuation of mycophenolate mofetil should be considered.
        • Treatment by or after consultation with pediatrician or dermatologist experienced in the use of mycophenolate mofetil for this indication.
Prophylaxis of rejection in heart and liver transplantation
  • Oral
    • 1 year up to 18 years
      • Initial dose: 1.200 mg/m²/day in 2 doses. Max: 2 g/day.
      • Maintenance dose: 1.200 - 1.800 mg/m²/day in 2 doses. Max: 3 g/day.
Prophylaxis for rejection of a transplanted kidney
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: Only administer intravenously if oral administration is impossible: Approximately 6 hours before the transplant 600 mg/m²/dose, once only.
      • Maintenance dose: 1.200 mg/m²/day in 2 doses.

      • As per the protocol and under the supervision of a nephrologist

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.

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.

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOSUPPRESSANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. 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
  3. 1A Pharma, SmPC Mycophenolat 250 mg Hartkapseln (67970.00.00), 12/2015
  4. Biomo, SmPC mycophenolatmofetil 250/500 mg Filmtabletten (80676.00.00 / 80677.00.00), 01/2018
  5. MMI, Online GL. Gelbe Liste Online, Accessed July 19, 2018
  6. Roche, SmPC CellCept® i.v. Infusionslösungskonzentrat (EU/1/96/005/005), 03/2018
  7. Roche, SmPC CellCept® orale Suspension (EU/1/96/005/006), 03/2018
  8. Roche, SmPC CellCept® 500 mg Filmtabletten (EU/1/96/005/002), 03/2018
  9. Roche, SmPC CellCept® 250 mg Kapseln (EU/1/96/005/001), 03/2018
  10. Arkin, L., et al, Mycophenolate Mofetil and Mood Changes in Children with Skin Disorders., Pediatr Dermatol, 2016, 33(3), e216-7
  11. Heller, M., et al, Mycophenolate mofetil for severe childhood atopic dermatitis: experience in 14 patients, Br J Dermatol, 2007, 157(1), 127-32
  12. 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
  13. Waxweiler, W. T., et al, Systemic treatment of pediatric atopic dermatitis with azathioprine and mycophenolate mofetil., Pediatr Dermatol, 2011, 28(6), 689-94
  14. Nederlandse Vereniging voor Dermatologie en Venerelogie, Richtlijn constitutioneel eczeem., https://nvdv.nl/professionals/richtlijnen-en-onderzoek/richtlijnen/richtlijn-constitutioneel-eczeem, 2019
  15. Roche, SmPC CellCept® orale Suspension (EU/1/96/005/006), 03/2018
  16. Roche Registration GmbH, SmPC Cellcept (EU/1/96/005/001) Rev 40; 17-02-2025, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose