IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Prescribe the topical that treats inflammatory lesions of rosacea. Help your patients get clearer faster and longer.1-3

Tube of cream.
Explore the Proposed Dual MOA of Ivermectin4-7
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See the Superior Efficacy vs METROCREAM® (Metronidazole) Topical Cream, 0.75%8,9
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Learn about the Highly Tolerable Safety Profile8,9
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aA phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily with METROCREAM (metronidazole) Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (Investigator’s Global Assessment [IGA] score of 3 or 4) over a 16-week treatment period (Part A). A total of 757 successfully treated subjects, rated clear or almost clear (IGA score of 0 or 1), continued to the 36-week extension evaluating relapse after a treatment-free period (Part B).1,2

In Part B, subjects were followed every 4 weeks for up to 36 additional weeks (Weeks 16-52). If relapse (defined as IGA score of ≥2 [mild, moderate, or severe]) occurred, subjects were re-treated with the same treatment they had received during the initial 16-week study (Part A). Re-treatment was stopped when subject(s) achieved an IGA of ≤1 (clear or almost clear), with a maximum duration of re-treatment of 16 consecutive weeks to mimic the Part A treatment duration. Several re-treatment periods were permitted.2

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.

Indication: METROCREAM® (metronidazole) Topical Cream,0.75% is indicated for topical application in the treatment of the inflammatory papules and pustules of rosacea. Adverse Events: In controlled clinical trials, the most commonly reported adverse events (<3%) included skin discomfort (burning/stinging), erythema, skin irritation, pruritus, and worsening of rosacea. Warnings/Precautions: Avoid contact of METROCREAM Topical Cream with the eyes as it may cause tearing. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. METROCREAM Topical Cream should be used with caution in patients with evidence of or a history of blood dyscrasia.

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. Taieb A, et al. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172:1103–1110. 2. Taieb A, et al. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study. J Eur Acad Dermatol Venereol. 2015;829–836. 3. Dall’Oglio F, et al. Clinical and erythema-directed imaging evaluation of papulo-pustular rosacea with topical ivermectin: a 32 weeks duration study. J Derm Treat. 2019: https://doi.org/10.1080/09546634.2019.1572860 4. 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 lmmunol lmmunopathol. 1995;44(3-4):347-358. 5. Labro MT. Anti-inflammatory activity of macrolides: a new therapeutic potential? J Antimicrob Chemother. 1998;41(suppl B):37-46. 6. Ci X, Li H, Yu Q, et al. Avermectin exerts anti-inflammatory effect by downregulating the nuclear transcription factor kappa-8 and mitogen-activated protein kinase activation pathway. Fundam Clin Pharmacol. 2009;23(4):449-455. 7. 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. 8. Taieb A, Ortonne JP, Ruzicka T, et al; lvermectin Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol.M 2015;172(4):1103-1110. 9. Taieb A, Khemis A, Ruzicka T, et al; lvermectin Phase III Study Group. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study. J Eur Acad Dermatol Venereal. 2016;30(5):829-836.

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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