Pimecrolimus

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Definition
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Lipophilic, immunosuppressive macrolactam derivative of ascomycin from the group of calcineurin inhibitors (see also Ciclosporin A, Tacrolimus).

Pharmacodynamics (Effect)
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Anti-inflammatory effect. Cell-selective inhibitor of the production and release of pro-inflammatory cytokines. Inhibition of the calcium-dependent phosphatase calcineurin. Blocking of transcription factors for the production of pro-inflammatory cytokines such as Interleukin 2, 4 and 10 as well as Interferon gamma. Furthermore, inhibition of the release of tumor necrosis factor by the mast cells.

Indication
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Short-term and intermittent long-term treatment of mild to moderate atopic eczema. Approved for patients from the age of 2 years.

Pregnancy/nursing period
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Insufficient data on use in pregnancy. In animal studies no evidence of damage to embryonic cells when used externally. Should not be prescribed during pregnancy. During lactation use only under reserve and not in the breast area.

Dosage and method of use
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Apply 2 times/day to the affected area.

Undesirable effects
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Especially at the beginning of the treatment, weak to moderate irritation can occur in the area of the application site. Occasionally bacterial or viral infections are described, especially impetigo, boils, herpes simplex.

Contraindication
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Hypersensitivity to Pimecrolimus, other macrolactams or auxiliary substances of the preparation (Elidel). Infected skin areas (herpes, varicella, pyoderma) must not be treated.

Preparations
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Elidel; Douglan

Note(s)
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  • Cave! Although Pimecrolimus is not genotoxic up to now, an FDA warning letter was published in March 2005: In animal experimental studies in mice it was shown that the topical application of Pimecrolimus can potentially lead to a reduction of the local immune response. Further studies ("repeat dose studies") in mice showed a dose- and therapy-dependent development of lymphomas. Dose-dependent carcinogenicity studies with perorally applied Pimecrolimus showed a dose- and therapy-dependent development of lymphomas and benign thymomas. Since 2006 the US-American product information carries a particularly emphasized warning notice (black box) in which the lack of knowledge about the long-term safety of the products regarding the development of skin cancer and lymphomas is explicitly pointed out.

  • It is recommended:
    • Use Pimecrolimus only according to the authorization in case of atopical eczema.
    • Use Pimecrolimus as second-line therapy in case of ineffectiveness or intolerance of first-line therapies.
    • Do not use Pimecrolimus in children < 2 years.
    • Use Pimecrolimus only for a short time (as short as possible) and intermittently but not as a permanent therapy.
    • Do not use Pimecrolimus in combination with UV-therapies.
  • After market introduction of the drugs, the occurrence of lymphomas was observed in patients who were treated topically with calcineurin inhibitors and steroids. However, this could not be confirmed in a subsequent study.
  • In the case of psoriasis inversa, clinical improvements after topical application of Pimecrolimus ( off-label-use) (see calcineurin inhibitors) showed in individual cases.

Literature
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  1. Arellano FM et al (2006) Risk of Lymphoma Following Exposure to Calcineurin Inhibitors and Topical Steroids in Patients with Atopic Dermatitis. J Invest Dermatol (epub)
  2. Eichenfield LF et al (2003) Elidel (pimecrolimus) cream 1%: a nonsteroidal topical agent for the treatment of atopic dermatitis. J Allergy Clin Immunol 111: 1153-1168
  3. Ortiz-Urda S, Rappersberger K (2003) New immunosuppressive agents for treating psoriasis. dermatologist 54: 230-236
  4. Rappersberger K (2002) Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol 119: 876-887
  5. Ständer S et al (2003) Antipruritic effects of pimecrolimus and tacrolimus. dermatologist 54: 413-417
  6. Williams H (2002) New treatments for atopic dermatitis. BMY 324: 1533-1534
  7. Wohlrab J (2006) Calcineurin inhibitors for the topical therapy of psoriasis. dermatologist 57: 685-689
  8. Zabawski E (2002) Treatment of cutaneous lupus with Elidel. Dermatol Online J 8: 25

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Last updated on: 29.10.2020