Elidel^®

Abbreviated Malaysian Prescribing Information¹

Indication: Elidel^® 1% cream is indicated for the treatment of patients 3 months of age and older with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible, this may include: Intolerance to topical corticosteroids. Lack of effect of topical corticosteroids. Use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate. Pack size: Elidel^® 1% cream is available in a tube of 15 g. Dosage and administration: Elidel^® 1% cream should be applied thinly to the affected areas twice daily. Elidel^® 1% cream may be used on all skin areas, including the head and face, neck and intertriginous areas, except on mucous membranes. Elidel^® 1% cream should not be applied under occlusion. For infants (3–23 months), children (2–11 years) and adolescents (12–17 years) the posology and method of administration are the same as for adults. Contraindications: Known hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients. Special warnings and precautions: Elidel^® 1% cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression. Elidel^® 1% cream should not be applied to (1) potentially malignant or pre-malignant skin lesions; and (2) areas affected by acute cutaneous viral infections (herpes simplex, chicken pox). Adverse reactions: Common reactions are application site burning, application site reactions (irritation, pruritus and erythema) and folliculitis. Uncommon to very rare reactions are impetigo, aggravated condition, herpes simplex dermatitis, molluscum contagiosum, rash, pain, paraesthesia, desquamation, dryness, oedema, skin papilloma, furuncle, alcohol intolerance, allergic reactions and skin discolouration. Interactions: Due to the minimal absorption of Elidel^® 1% cream, a potential systemic interaction with vaccination is unlikely to occur. Pregnancy and lactation: Based on the minimal extent of Elidel^® 1% cream absorption after topical application, the potential risk for humans is considered limited. However, Elidel^® 1% cream should not be used during pregnancy. Caution should be exercised when Elidel^® 1% cream is administered to breastfeeding women. There are no clinical data on the effects of Elidel^® 1% cream on male or female fertility. Storage: Do not store above 30°C. Do not freeze.

API-ELIDEL-0424

Reference: 1. Elidel^® Malaysia Prescribing Information dated on 1 April 2024.