(pim e KROE li mus)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Elidel: 1% (30 g, 60 g, 100 g) [contains benzyl alcohol, cetyl alcohol, propylene glycol]
Brand Names: U.S.
- Calcineurin Inhibitor
- Immunosuppressant Agent
- Topical Skin Product
Penetrates inflamed epidermis to inhibit T cell activation by blocking transcription of proinflammatory cytokine genes such as interleukin-2, interferon gamma (Th1-type), interleukin-4, and interleukin-10 (Th2-type). Pimecrolimus binds to the intracellular protein FKBP-12, inhibiting calcineurin, which blocks cytokine transcription and inhibits T-cell activation. Prevents release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.
Topical: Low systemic absorption; blood concentration of pimecrolimus was routinely <2 ng/mL with treatment of atopic dermatitis in adult patients (13% to 62% BSA involvement); blood concentration of pimecrolimus was <3 ng/mL in 26 pediatric patients 2 to 14 years of age with atopic dermatitis (20% to 69% BSA involvement). Detectable blood levels were observed in a higher proportion of children as compared to adults and may be due to the larger surface area to body mass ratio seen in pediatric patients (Menter 2009).
Hepatic via cytochrome (CYP) P450 3A4
Feces (78.4% as metabolites; <1% as unchanged drug)
Onset of Action
Time to significant improvement: 8 days (Wellington 2001)
Time to Peak
Serum: Topical: 2 to 6 hours
Terminal: Oral: 30 to 40 hours
99.5%, primarily to various lipoproteins
Use: Labeled Indications
Atopic dermatitis: Second-line therapy for short-term and noncontinuous long-term treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients 2 years and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
Off Label Uses
Intertriginous and facial psoriasis
Data from a double-blind, randomized, vehicle-controlled study supports the use of pimecrolimus in the treatment of inverse psoriasis [Gribetz 2004]. In patients with this condition, pimecrolimus was effective, safe, and well-tolerated.
Based on the American Academy of Dermatology Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis; Sec. 3, Management and Treatment of Psoriasis with Topical Therapies, pimecrolimus given for the treatment of intertriginous and facial psoriasis is effective and recommended in the management of this condition.
Oral lichen planus
Data from short-term controlled trials demonstrate that topical pimecrolimus is effective in improving clinical symptoms of oral lichen planus and may be considered an alternative therapy for patients who do not respond to topical steroids. Additional data may be necessary to further define the role of pimecrolimus in this condition.
According to guidelines, topical calcineurin inhibitors, including pimecrolimus, are considered first-line therapy for children and adults with vitiligo; use should be limited to the head and neck regions. While guidelines endorse the use of calcineurin inhibitor monotherapy, there are few well-designed randomized controlled trials evaluating pimecrolimus monotherapy for vitiligo. Long-term safety and efficacy data are unavailable.
Hypersensitivity to pimecrolimus or any component of the formulation
Atopic dermatitis (mild to moderate): Topical: Apply thin layer to affected area twice daily. Note: Limit application to involved areas. Discontinue use when symptoms have resolved; re-evaluate if symptoms persist >6 weeks.
Oral lichen planus (off-label use): Topical: Apply twice daily for 1 month (Passeron 2007; Swift 2005; Volz 2008)
Psoriasis (off-label use): Topical: Apply twice daily (Gribetz 2004; Menter 2009)
Vitiligo (off-label use): Topical: Apply twice daily for 6 months. Treatment beyond 12 months may be useful; long-term safety has not been established. (Esfandiarpour 2009; Stinco 2009; Taieb 2013)
Refer to adult dosing.
Atopic dermatitis (mild-to-moderate): Children ≥2 years and Adolescents: Topical: Refer to adult dosing.
Apply a thin layer to affected skin. Limit application to areas of involvement. Do not use with occlusive dressings. Burning at the application site is most common in first few days; improves as atopic dermatitis improves. Discontinue use when symptoms have resolved; re-evaluate if symptoms persist >6 weeks. Moisturizers may be applied after use of pimecrolimus cream. Wash hands before and after use.
Oral lichen planus (off-label use): Apply to affected oral mucosa, cover with a thin layer of gauze to delay dilution with saliva (Volz 2008). Eating, drinking, or chewing gum was not allowed for 30 minutes after application (Passeron 2007).
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze.
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of Pimecrolimus. Exceptions: Grapefruit Juice. Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of Pimecrolimus. Monitor therapy
Immunosuppressants: Pimecrolimus may enhance the adverse/toxic effect of Immunosuppressants. Exceptions: Cytarabine (Liposomal). Avoid combination
Central nervous system: Headache (children and adolescents 11% to 25%; adults 7%), fever (children and adolescents 13%; adults 1%)
Infection: Influenza (3% to 13%)
Local: Local burning (adults 26%; children and adolescents 2% to 8%; tends to resolve/improve as lesions resolve), application site reaction (adults 15%; children and adolescents 2%)
Respiratory: Nasopharyngitis (infants, children, and adolescents 10% to 27%; adults 8%), upper respiratory tract infection (children and adolescents 14% to 19%; adults 4%), cough (children and adolescents 9% to 16%; adults 2%), bronchitis (children and adolescents ≤11%; adults ≤2%)
1% to 10%:
Dermatologic: Folliculitis (adults 6%; children and adolescents 1%), skin infection (5% to 6%), impetigo (4%), warts (children and adolescents ≤3%), acne vulgaris (≤2%), herpes simplex dermatitis (≤2%), molluscum contagiosum (children and adolescents ≤2%), urticaria (≤1%)
Gastrointestinal: Diarrhea (children and adolescents 1% to 8%; adults ≤2%), gastroenteritis (children and adolescents ≤7%; adults 2%), vomiting (1% to 4%), constipation (children and adolescents ≤4%), abdominal pain (≤3%), toothache (≤3%), nausea (1% to 2%)
Genitourinary: Dysmenorrhea (1% to 2%)
Hypersensitivity: Hypersensitivity (3% to 5%)
Infection: Viral infection (children and adolescents ≤7%), herpes simplex infection (≤4%), bacterial infection (1% to 2%), staphylococcal infection (1% to 2%), varicella (≤1%)
Local: Local irritation (adults ≤6%; children and adolescents ≤1%), local pruritus (1% to 6%), localized erythema (≤2%)
Neuromuscular & skeletal: Arthralgia (≤2%), back pain (≤2%)
Ocular: Conjunctivitis (≤2% to 3%), eye infection (≤1%)
Otic: Otic infection (1% to 6%), otitis media (1% to 3%)
Respiratory: Sore throat (4% to 8%), pharyngitis (children and adolescents 1% to 8%; adults 1%), tonsillitis (children and adolescents ≤6%; adults <1%), asthma (3% to 4%), asthma aggravated (children and adolescents ≤4%), streptococcal pharyngitis (children and adolescents 3%), nasal congestion (1% to 3%), sinusitis (1% to 3%), epistaxis (≤3%), dyspnea (≤2%), flu-like symptoms (≤2%), pneumonia (≤2%), rhinitis (≤2%), rhinorrhea (children and adolescents ≤2%), viral upper respiratory tract infection (≤2%), wheezing (children and adolescents ≤1%)
Miscellaneous: Laceration (children and adolescents ≤2%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, eczema (herpeticum), eye irritation (following application near eyes), facial edema, flushing (ethanol-associated), lymphadenopathy, malignant neoplasm (basal cell carcinoma, squamous cell carcinoma, malignant melanoma, malignant lymphoma), skin discoloration
Concerns related to adverse effects:
• Infection: Patients with atopic dermatitis are predisposed to skin infections; therapy has been associated with an increased risk of developing eczema herpeticum, varicella zoster, and herpes simplex. Do not apply to areas of active bacterial or viral infection; local infections at the treatment site should be resolved prior to therapy.
• Local symptoms: May cause local symptoms (eg, burning, pruritus, soreness, stinging) during first few days of treatment; usually self-resolving as atopic dermatitis lesions heal.
• Lymphadenopathy: May be associated with development of lymphadenopathy; possible infectious causes should be investigated. Discontinue use in patients with unknown cause of lymphadenopathy or acute infectious mononucleosis.
• Malignancy: [US Boxed Warning]: Topical calcineurin inhibitors (including pimecrolimus) have been associated with rare cases of lymphoma and skin malignancy; avoid use on malignant or premalignant skin conditions (eg, cutaneous T-cell lymphoma).
• Skin papilloma: Skin papilloma (warts) have been observed with use; discontinue use if there is worsening of skin papillomas or they do not respond to conventional treatment.
• Atopic dermatitis: Diagnosis should be reconfirmed if sign/symptoms do not improve within 6 weeks of treatment.
• Erythroderma: Safety not established in patients with generalized erythroderma.
• Skin diseases which may increase systemic absorption: Not recommended for use in patients with Netherton's syndrome or skin conditions which may increase the potential for systemic absorption.
• Immunocompromised patients: Should not be used in immunocompromised patients, including patients on concomitant systemic immunosuppressive therapy.
• Pediatric: [US Boxed Warning]: Use of pimecrolimus in children <2 years of age is not recommended, particularly since the effect on immune system development is unknown.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
• Appropriate use: [US Boxed Warning]: Continuous long-term use of calcineurin inhibitors (including pimecrolimus) should be avoided and application of cream should be limited to areas of involvement with atopic dermatitis. Safety of intermittent use for >1 year has not been established.
• Sun exposure: Avoid artificial or natural sunlight exposure, even when pimecrolimus is not on the skin.
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies following topical application.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience flu-like symptoms, sensation of warmth, stinging, headache, cough, rhinorrhea, rhinitis, or pharyngitis. Have patient report immediately to prescriber enlarged lymph nodes, warts, cold sores, severe burning, severe skin irritation, skin infection, skin ulcers, skin growths, or mole changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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- Drug class: miscellaneous topical agents
Other brands: Elidel