IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Soolantra®

(ivermectin) Cream, 1%

Not an actual patient
 

Combat inflammatory lesions of rosacea

SOOLANTRA Cream combats inflammatory lesions of rosacea with a formulation designed for tolerability, utilizing CETAPHIL® Moisturizing Cream as the basis for the vehicle.1

Proposed dual MOA of ivermectin2-5,a

Anti-Inflammatory.
Anti-Inflammatory
  • Decreases cellular and humoral immune responses
  • Parent compound avermectin has been shown to significantly regulate TNF-α, IL-1β, and IL-10 in lipopolysaccharide-induced inflammation in in vitro studies
Antiparasitic.
Antiparasitic6
  • Vermicide
  • Demodex
    • Published clinical case series

aThe mechanism of action (MOA) of SOOLANTRA (ivermectin) Cream, 1% in treating rosacea lesions is unknown.

Interview with Dr. Linda Stein Gold, SOOLANTRA Cream Clinical Investigator

Knowing there is an innovative treatment available to keep my rosacea bumps and blemishes under control is really encouraging and exciting*

Woman with rosacea.

Not an actual patient

*Individual results may vary

SOOLANTRA Cream application instructions

Instruct patients to:

Apply SOOLANTRA Cream to the affected areas of the face once a day. Use a pea-sized amount of SOOLANTRA Cream for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer across the affected areas of the face, avoiding the eyes and lips.

  • Hands should be washed after applying SOOLANTRA Cream
  • Cosmetics may be applied after SOOLANTRA Cream has dried
  • SOOLANTRA Cream is not for oral, ophthalmic, or intravaginal use
Tube of Soolantra cream.

Important Safety Information

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Not for oral, ophthalmic or intravaginal use. Adverse Events: In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.


References: 1. Data on file. Galderma Laboratories, L.P. 2. Stankiewicz M, Cabaj W, Jonas WE, Moore LG, Millar K, Ng Chie W. Influence of ivermectin on cellular and humoral immune responses of lambs. Vet Immunol and Immunopathol. 1995;44:347-358. 3. Labro MT. Anti-inflammatory activity of macrolides: a new therapeutic potential? J Antimicrob Chemother. 1998;41(suppl B):37-46. 4. Ci X, Li H, Yu Q, et al. Avermectin exerts anti-inflammatory effect by downregulating the nuclear transcription factor kappa-B and mitogen-activated protein kinase activation pathway. Fundam Clin Pharmacol. 2009;23:449-455. 5. Del Rosso JQ, Gallo RL, Kircik L, Thiboutot D, Baldwin HE, Cohen D. Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune response in rosacea-prone skin. J Drugs Dermatol. 2012;11(6):694-700. 6. Schaller M, et al. Dual anti-inflammatory and anti-parasitic action of topical ivermectin 1 % in papulopustular rosacea. J Eur Acad Dermatol Venereal. 2017;31:7907-1911.

See Important Safety Information

IMPORTANT SAFETY INFORMATION

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.
Warnings / Precautions: Not for oral, ophthalmic or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.

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