pimecrolimus
Regulatory sources consulted
Approved indications
- Mild-to-moderate atopic dermatitis from 3 months of age when topical corticosteroids are unsuitable, ineffective, or not tolerated, including the face and neck.
Contraindications
Absolute
- Hypersensitivity to pimecrolimus, other macrolactams, or excipients.
Clinical warnings
- Major warning · Do not use in immunodeficiency, immunosuppression, malignant or premalignant lesions, or acute viral skin infection. Treat infections before starting and stop on the affected area for herpes. — CIMA/AEMPS, ficha técnica 65029
- Major warning · Avoid excessive sunlight or UV exposure, PUVA, UVA, and UVB; do not use under occlusion. Investigate lymphadenopathy and stop if no clear cause exists or mononucleosis is present. — CIMA/AEMPS, ficha técnica 65029
- Major warning · It is not recommended in Netherton syndrome or erythroderma. Extensive inflammation or severe skin damage may increase systemic pimecrolimus concentrations. — CIMA/AEMPS, ficha técnica 65029
- Major warning · Malignancies, including cutaneous and other lymphomas and skin cancer, have been reported during topical pimecrolimus use; a causal relationship has not been established. — CIMA/AEMPS, ficha técnica 65029
Drug interactions
- HighUV phototherapy, PUVA, or other immunosuppressants for eczema
Mechanism: Experience is insufficient and immunosuppression or UV risk may increase.
Recommendation: Avoid the combination.
CIMA/AEMPS, ficha técnica 65029https://cima.aemps.es/cima/dochtml/ft/65029/FT_65029.html
- LowAlcohol
Mechanism: Flushing, rash, burning, itching, or swelling has rarely occurred after intake.
Recommendation: Warn about this reaction and stop intake if it occurs.
CIMA/AEMPS, ficha técnica 65029https://cima.aemps.es/cima/dochtml/ft/65029/FT_65029.html
Adverse events
Common (≥1%)
Application-site burning · Local irritation, itching, or erythema · Folliculitis
Rare but serious
Severe anaphylactic reaction · Angioedema
Pregnancy and lactation
Do not use during pregnancy. During breastfeeding, it may be used cautiously but must not be applied to the breasts.
Recent literature (PubMed)
Lichen sclerosus (LS) is an underdiagnosed inflammatory mucocutaneous condition affecting the anogenital areas. Postmenopausal women are predominantly affected and, to a lesser extent, men, prepubertal children, and adolescents. The etiology of LS is still unknown. Hormonal status, frequent trauma and autoimmune diseases are well-known associations for LS, yet infections do not seem to be clear risk factors. LS pathogenesis involves factors such as a genetic predisposition and an immune-mediated Th1-specific IFNγ-induced phenotype. Furthermore, there is a distinct expression of tissue remodeling associated genes as well as microRNAs. Oxidative stress with lipid and DNA peroxidation provides an enabling microenvironment to autoimmunity and carcinogenesis. Circulating IgG autoantibodies against the extracellular matrix protein 1 and hemidesmosome may contribute to the progression of LS or simply represent an epiphenomenon. The typical clinical picture includes chronic whitish atrophic patches along with itching and soreness in the vulvar, perianal and penile regions. In addition to genital scarring, and sexual and urinary dysfunction, LS may also lead to squamous cell carcinoma. Disseminated extragenital LS and oral LS are also reported. The diagnosis is usually clinical; however, a skin biopsy should be performed in case of an unclear clinical picture, treatment failure or suspicion of a neoplasm. The gold-standard therapy is the long-term application of ultrapotent or potent topical corticosteroids and, alternatively, topical calcineurin inhibitors such as pimecrolimus or tacrolimus. Collectively, LS is a common dermatological disease with a so far incompletely understood pathogenesis and only limited treatment options. To foster translational research in LS, we provide here an update on its clinical features, pathogenesis, diagnosis and (emerging) treatment options.
Rosacea is a chronic cutaneous disorder affecting primarily the face, characterized by erythema, transient or persistent, telangiectasia, and inflammatory lesions including papulo-pustules and swelling. The essential component of the disease is the persistent erythema of facial skin. Episodes of flushing (acute-subacute intermittent vasodilation) are common. Swelling and erythema of the nose along with dilatation of the pilosebaceous poral orifices, known as rhinophyma, can be noted in chronic cases. Rosacea affects up to 10% of the world population and is especially noted in fair-skinned individuals aged 35-50. Women are affected more often than men. Several treatment modalities including topical medications, systemic drugs, lasers, and light-based therapies have been used for the management of rosacea with variable results. Topical medications such as azelaic acid, metronidazole, and sulfacetamide/sulfur, oral antibiotics such as tetracyclines, and oral retinoids alone or, most commonly, in combination form the mainstay of treatment. Light therapies such as intense pulsed light and pulsed dye laser are best used for the erythemato-telangiectatic type. Topical brimonidine, oxymetazoline, ivermectin, tacrolimus, pimecrolimus, low-dose modified-release tetracyclines and botulinum toxin are the new additions to the therapeutic armamentarium. This article provides a comprehensive review of the various therapies used for rosacea.
Atopic dermatitis (AD) is a common skin condition with multiple topical treatment options, but uncertain comparative effects. We sought to systematically synthesize the benefits and harms of AD prescription topical treatments. For the 2023 American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters AD guidelines, we searched MEDLINE, EMBASE, CENTRAL, CINAHL, LILACS, ICTRP, and GREAT databases to September 5, 2022, for randomized trials addressing AD topical treatments. Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random-effects network meta-analyses addressed AD severity, itch, sleep, AD-related quality of life, flares, and harms. The Grading of Recommendations Assessment, Development and Evaluation approach informed certainty of evidence ratings. We classified topical corticosteroids (TCS) using 7 groups-group 1 being most potent. This review is registered in the Open Science Framework (https://osf.io/q5m6s). The 219 included trials (43,123 patients) evaluated 68 interventions. With high-certainty evidence, pimecrolimus improved 6 of 7 outcomes-among the best for 2; high-dose tacrolimus (0.1%) improved 5-among the best for 2; low-dose tacrolimus (0.03%) improved 5-among the best for 1. With moderate- to high-certainty evidence, group 5 TCS improved 6-among the best for 3; group 4 TCS and delgocitinib improved 4-among the best for 2; ruxolitinib improved 4-among the best for 1; group 1 TCS improved 3-among the best for 2. These interventions did not increase harm. Crisaborole and difamilast were intermediately effective, but with uncertain harm. Topical antibiotics alone or in combination may be among the least effective. To maintain AD control, group 5 TCS were among the most effective, followed by tacrolimus and pimecrolimus. For individuals with AD, pimecrolimus, tacrolimus, and moderate-potency TCS are among the most effective in im
Eczema (atopic dermatitis) is the most burdensome skin condition worldwide and cannot currently be prevented or cured. Topical anti-inflammatory treatments are used to control eczema symptoms, but there is uncertainty about the relative effectiveness and safety of different topical anti-inflammatory treatments. To compare and rank the efficacy and safety of topical anti-inflammatory treatments for people with eczema using a network meta-analysis. We searched the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries on 29 June 2023, and checked the reference lists of included studies. We included within-participant or between-participant randomised controlled trials (RCTs) in people of any age with eczema of any severity, but excluded trials in clinically infected eczema, seborrhoeic eczema, contact eczema, or hand eczema. We included topical anti-inflammatory treatments used for at least one week, compared with another anti-inflammatory treatment, no treatment, or vehicle/placebo. Vehicle is a 'carrier system' for an active pharmaceutical substance, which may also be used on its own as an emollient for dry skin. We excluded trials of topical antibiotics used alone, complementary therapies, emollients used alone, phototherapy, wet wraps, and systemic treatments. We used standard Cochrane methods. Primary outcomes were patient-reported eczema symptoms, clinician-reported eczema signs and investigator global assessment. Secondary outcomes were health-related quality of life, long-term control of eczema, withdrawal from treatment/study, and local adverse effects (application-site reactions, pigmentation changes and skin thinning/atrophy were identified as important concerns through patient and public involvement). We used CINeMA to quantify our confidence in the evidence for each outcome. We included 291 studies involving 45,846 participants with the full spectrum of eczema severity, mainly conducted in high-income countries in secondary care