Pharmacokinetics in children

The resorption of topical pimecrolimus is low, independently of body surface area (BSA) and duration of treatment (Staab et al. 2005, Lakhanpaul et al. 2006). Blood levels of 58 children (3 months to 14 years of age with affected BSA 10-92%) who were treated with topical pimecrolimus 1% cream twice daily were similar to those of adults with approximately 60% <0.5 ng/ml and 97% <2 ng/ml (max. 2 ng/ml). In infants (3 to 23 months), the highest measured blood level was 2.6 ng/ml (SmPC Elidel 10 mg/g Meda Pharma 10/2018, Lakhanpaul et al. 2006, Staab et al. 2005, Allen et al. 2003).

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

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

The major AEs were transient mild to moderate stinging sensation, dry skin and moderate pruritus at the application site (Allen et al. 2003, Wollenberg et al. 2020).
Unlike topical corticosteroids, long-term use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for treatment especially in sensitive skin areas (Luger et al. 2015).

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

In 2006, the FDA added a black-box warning to the Topical Calcineurin Inhibitors' labels that long-term use has not been established and warned about a theoretical increased risk of lymphoma and skin malignancies.
Based on the review of the current evidence (short-term and long-term studies) including >4000 infants (<2 years), these safety concerns are no longer valid. Studies indicate that pimecrolimus is a safe and effective alternative to topical corticosteroids in infants >3 months (Luger et al. 2021).
No marked increased rates of any lymphoma were found in children treated with pimecrolimus (Castellsague et al. 2018).

Interactions

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

References

1. Novartis Pharma BV, SPC Elidel RVG 28742, www.cbg-meb.nl, Geraadpleegd 02 juli 2010, http://db.cbg-meb.nl/IB-teksten/h28742.pdf
2. CBO, Richtlijn Constitutioneel Eczeem, www.cbo.nl, Maart 2015
3. MEDA Pharma GmbH & Co. KG, SmPC, Elidel® 10 mg/g Creme (54804.00.00), 11/21
4. Uptodate: UpToDate®, Pediatric Drug information: Pimecrolimus Lexicomp® Topic 12706 Version 90.0, accessed 01/19
5. Staab, D., et al., Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial. , Pediatr Allergy Immunol, 2005, 16(6), 527-33
6. Lakhanpaul, M., et al., Low systemic exposure in infants with atopic dermatitis in a 1-year pharmacokinetic study with pimecrolimus cream 1%*, Exp Dermatol, 2006, 15(2), 138-41
7. Schneider, L., et al., Study of the Atopic March: Development of Atopic Comorbidities. , Pediatr Dermatol, 2016, 33(4), 388-98
8. Wollenberg, A., et al., Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I., J Eur Acad Dermatol Venereol, 2018, 32(5), 657-682
9. Breuer, K., et al., Influence of pimecrolimus cream 1% on different morphological signs of eczema in infants with atopic dermatitis. , Dermatology, 2004, 209(4), 314-20
10. Staab, D., et al., Low systemic absorption and good tolerability of pimecrolimus, administered as 1% cream (Elidel) in infants with atopic dermatitis--a multicenter, 3-week, open-label study. , Pediatr Dermatol, 2005, 22(5), 465-71
11. Allen, B.R., et al., Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients., Arch Dis Child, 2003, 88(11), 969-73
12. Castellsague, J., et al., A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation - JOELLE study). , Clin Epidemiol, 2008, 10, 299-310
13. Luger, T., et al., Unmet medical needs in the treatment of atopic dermatitis in infants: An Expert consensus on safety and efficacy of pimecrolimus., Pediatr Allergy Immunol, 2021, 32(3), 414-424
14. Staab, D., et al., Treatment of infants with atopic eczema with pimecrolimus cream 1% improves parents' quality of life: a multicenter, randomized trial., Pediatr Allergy Immunol, 2005, 16(6), 527-33
15. Castellsague, J., et al., A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation - JOELLE study)., Clin Epidemiol, 2008, 10, 299-310
16. Mylan Healthcare B.V, SmPC Elidel (RVG 28742) 28-10-2021, www.geneesmiddelinformatiebank.nl
17. Breuer, K., et al., Influence of pimecrolimus cream 1% on different morphological signs of eczema in infants with atopic dermatitis., Dermatology, 2004, 209(4), 314-20
18. Schneider, L., et al., Study of the Atopic March: Development of Atopic Comorbidities., Pediatr Dermatol, 2016, 33(4), 388-98
19. Staab, D., et al., Low systemic absorption and good tolerability of pimecrolimus, administered as 1% cream (Elidel) in infants with atopic dermatitis--a multicenter, 3-week, open-label study., Pediatr Dermatol, 2005, 22(5), 465-71

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