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Soolantra prescribing summary card_Index image

This prescribing summary card was developed from content provided by Galderma UK Ltd in a format developed by Guidelines. See below for full disclaimer.

Information intended for healthcare professionals only.

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Indications1

  • Soolantra® is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients

Dose1

  • One gram of cream contains 10 mg of ivermectin
  • One application a day for up to 4 months. Soolantra® should be applied daily over the treatment course. The treatment course may be repeated. It can be applied as monotherapy or as part of combination treatment
  • In case of no improvement after 3 months, the treatment should be discontinued.

Method of administration1

  • Cutaneous use only
  • Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa
  • Soolantra should be applied only to the face
  • Hands should be washed after applying the medicinal product
  • Cosmetics may be applied after the medicinal product has dried.

Mode of action1

  • Ivermectin is a member of the avermectin class. Avermectin has anti-inflammatory effects by inhibiting lipopolysaccharide-induced production of inflammatory cytokines
  • Ivermectin also causes death of parasites, primarily through binding selectively and with high affinity to glutamate-gated chloride channels, which occur in invertebrate nerve and muscle cells
  • The mechanism of action of Soolantra® in treating the inflammatory lesions of rosacea is not known but may be linked to anti-inflammatory effects of ivermectin as well as causing the death of Demodex mites that have been reported to be a factor in inflammation of the skin.

Warnings and precautions1

  • Patients may experience transient aggravation of rosacea, which usually resolves within 1 week under continuation of the treatment as might be expected due to a reaction to the dying Demodex mites
  • In case of severe worsening with a strong dermal reaction, the treatment should be discontinued
  • Soolantra has not been studied in patients with renal or hepatic impairment
  • The medicinal product contains:
    • cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)
    • methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed)
    • and propylene glycol which may cause skin irritation.

Undesirable effects1

  • The most commonly reported adverse reactions are skin burning sensation, skin irritation, pruritus and dry skin, all occurring in 1% or less of patients treated with the medicinal product in clinical trials
    • they are typically mild-to-moderate in severity, and usually decrease when treatment is continued.

Guideline recommendations

  • Primary Care Dermatology Society (PCDS)2
    • has a high strength of recommendation for ivermectin in the treatment of inflammatory papules and pustules of rosacea
  • All Wales Medicines Strategy Group (AWMSG) advice3
    • Ivermectin (Soolantra®) is recommended as an option for use within NHS Wales for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients.
  • Scottish Medicines Consortium (SMC) advice4
    • following a full submission, ivermectin (Soolantra®) is accepted for restricted use within NHS Scotland
    • indication under review: Topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients
    • SMC restriction: the treatment of moderate to severe inflammatory lesions of rosacea where a topical treatment is considered appropriate.
  • NICE Clinical Knowledge Summaries5
    • Invermectin is recommended topically as first-line treatment for mild-to-moderate papules and/or pustules of rosacea.

Clinical evidence

  • Soolantra® is more effective versus metronidazole 0.75% cream in reducing inflammatory lesions (83% reduction versus 73.7%, p<0.001 at week 16, n=962)6
  • Soolantra® gives more time clear (Investigator Global Assessment (IGA) 0[A]) from rosacea7
  • Soolantra® extends median time to relapse versus metronidazole 0.75% cream (115 days versus 85 days, p=0.0365)7
  • ‘Clear’ (IGA 0) improved quality of like 50% versus ‘almost clear’ (IBA 1) across all 6 aspects covered by the Dermatology Life Quality Index (DLQI) including social life and personal relationships (mean reduction from baseline; 6.1 versus 4.0, p<0.001).8

References

  1. Galderma UK Ltd. Soolantra 10mg/g Cream—summary of product characteristics. www.medicines.org.uk/emc/ (accessed August 2021)
  2. Primary Care Dermatology Society.Concise guidance: National Primary Care Treatment and Referral Guidelines for Common Skin Conditions—Rosacea. PCDS, 2021. Available at: www.pcds.org.uk/desktop-treatment-guide#10-rosacea (accessed August 2021)
  3. All Wales Medicines Strategy Group. ivermectin (Soolantra®). AWMSG, 2016 (last reviewed March 2019). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/ivermectin-soolantra/
  4. Scottish Medicines Consortium. ivermectin (Soolantra®). SMC, 2015. Available at: www.scottishmedicines.org.uk/medicines-advice/ivermectin-soolantra-fullsubmission-110415/
  5. NICE Clinical Knowledge Summaries. Rosacea: Scenario: Rosacea. NICE, last revised January 2021. Available at: https://cks.nice.org.uk/topics/rosacea/management/rosacea/ (accessed August 2021)
  6. 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
  7. 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 Venereo, 2015; 30: 829–36
  8. Webster G et al. Defining treatment success in rosacea as ‘clear’ may provide multiple patient benefits: results of a pooled analysis. J Dermatolog Treat, 2017; 28: 469–474

[A] The severity of rosacea is measured using a 5-point IGA scale in order to define the success of treatment, A final score of IGA 0 is ‘clear’ of rosacea lesions and erythema. 

This prescribing summary card was developed from content provided by Galderma UK Ltd in a format developed by GuidelinesGalderma UK Ltd commissioned the development of the prescribing card and carried out full medical approval to ensure compliance with regulations. No part of this publication may be reproduced in any form without the permission of the publisher.

UKI-SOC-2100030

Date of preparation: September 2021