Pimecrolimus

ELIDEL

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Pronunciation: pim-e-KROE-li-mus (EL-ee-del)

Pimecrolimus ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Pimecrolimus ballicule

What it isTopical calcineurin inhibitor; mild-to-moderate atopic dermatitis.

Why this oneIts cream vehicle suits mild facial or flexural eczema; it is weaker than tacrolimus ointment but avoids steroid atrophy.

What limits itEarly application burning can stop treatment; photoprotection is advised, and long-term safety remains uncertain.

Pimecrolimus molecular structure (skeletal formula) — Molecular structure: Pimecrolimus

FDA-approved for

mild-to-moderate atopic dermatitis (2001)

Off-label

vitiligo
oral and genital lichen planus

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Long-term safety of topical calcineurin inhibitors not established; rare malignancy (skin, lymphoma) reports; avoid continuous long-term use; not for children <2 yr.

FDA dosing	Population	Start	Target	Max
Atopic dermatitis (second-line, short-term & intermittent)	Adults & children ≥2 yr	Apply thin layer BID	BID

Renal Undefined

Hepatic Undefined

Instructions

Apply a thin layer to affected skin twice daily; stop when signs/symptoms resolve
Re-examine if disease persists beyond 6 wk
Avoid continuous long-term use; limit to areas of involvement
Avoid occlusive dressings
Minimize/avoid natural or artificial sunlight

Available strengths

cream 1 %

Cautions

Not for immunocompromised adults/children or those on systemic immunosuppressants
Avoid on malignant or pre-malignant skin conditions (e.g., cutaneous T-cell lymphoma)
Not for Netherton's syndrome or conditions with increased systemic absorption
Resolve bacterial/viral skin infections before use
Investigate etiology of lymphadenopathy if it develops

Adverse reactions

Application site burning
Headache
Nasopharyngitis
Cough
Influenza
Pyrexia
Viral infection

Pregnancy Category C; no adequate studies; use only if benefit justifies risk.

Lactation Unknown whether excreted in human milk; decide whether to discontinue nursing or drug.

Cost

Pimecrolimus (ELIDEL)

Strength		#/mo	generic $/unit	CostPlus
1 %	cream	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Pimecrolimus is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2018

⚠ BOXED WARNING

Long-term safety not established; rare malignancy reported

Principal riskBurning on application; less potent than tacrolimus

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.

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