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New Drug Reviews

Ivermectin 1% Cream (Soolantra) for Inflammatory Lesions of Rosacea

 


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Am Fam Physician. 2016 Sep 15;94(6):512-513.

Ivermectin 1% cream (Soolantra) is a topical prescription medication labeled for the treatment of inflammatory lesions of rosacea. Its mechanism of action is unknown1 but may be due to a combination of its anti-inflammatory effects and its antiparasitic effects on the Demodex mite, which lives on the skin and may contribute to the symptoms of rosacea.2

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DrugDosageDose formCost*

Ivermectin 1% cream (Soolantra)

Apply a thin layer to the entire face once daily

Cream (each gram of cream contains 10 mg of ivermectin)

$320


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed August 1, 2016).

DrugDosageDose formCost*

Ivermectin 1% cream (Soolantra)

Apply a thin layer to the entire face once daily

Cream (each gram of cream contains 10 mg of ivermectin)

$320


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed August 1, 2016).

SAFETY

Studies have shown ivermectin cream to be safe with no serious adverse effects. In randomized trials, the rate of adverse effects was similar to those of vehicle, metronidazole gel, and azelaic acid (Azelex), and no systemic adverse effects occurred.35 Two trials that studied 707 patients for up to one year revealed no safety concerns.5 Ivermectin cream is a U.S. Food and Drug Administration pregnancy category C drug.

TOLERABILITY

Ivermectin cream is generally well tolerated. About one in 77 patients will stop using ivermectin cream by 16 weeks because of adverse effects.3,4 For patients using ivermectin cream for up to one year, one in 83 will discontinue treatment because of adverse effects.5 Pooled drop-out rates are similar for patients using vehicle, metronidazole cream, or azelaic acid.35 A small proportion of patients (less than 2%) will experience local adverse effects such as a burning skin sensation (1.3%), skin irritation (1%), pruritus (0.8%), and dry skin (0.7%).6 These effects are usually transient and will decrease over

Address correspondence to John D. Gazewood, MD, MSPH, at jdg3k@virginia.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. U.S. National Library of Medicine. DailyMed: Soolantra—ivermectin cream. Drug label information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1d5b166-ab06-4ab5-b0c6-31126238118a. Accessed February 19, 2016....

2. Ivermectin cream (Soolantra) for rosacea. Med Lett Drugs Ther. 2015;57(1466):51–52.

3. Taieb A, Ortonne JP, Ruzicka T, et al.; Ivermectin 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. 2015;172(4):1103–1110.

4. Stein L, Kircik L, Fowler J, et al. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316–323.

5. Stein Gold L, Kircik L, Fowler J, et al.; Ivermectin Phase 3 Study Group. Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea. J Drugs Dermatol. 2014;13(11):1380–1386.

6. Peace J, Williams HC. Inflammatory lesions of papulopustular rosacea: ivermectin 10 mg/g cream. NICE advice [ESNM68]. National Institute for Health and Care Excellence; January 2016:23.

7. Taieb A, Khemis A, Ruzicka T, et al.; Ivermectin Phase III Study Group. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream. J Eur Acad Dermatol Venereol. 2016;30(5):829–836.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.



 

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