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Antifungals, Topical Antifungals, Topical Therapeutic Class Review (TCR) November 17, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. November 2020 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Tinea Tinea Tinea Tinea Cutaneous Drug Other pedis cruris versicolor corporis candidiasis butenafine Relief of itching, burning, and X X -- X -- (Lotrimin Ultra® [OTC])1 cracking butenafine X X X X -- -- (Mentax®)2 ciclopirox 0.77% X X X X X -- (Ciclodan® cream,3 ciclopirox 0.77% Seborrheic scalp dermatitis (Loprox®/cream/gel/ X X X X X (Loprox 1% shampoo only) suspension) 4,5,6,7 ciclopirox 8% Topical treatment in (Ciclodan solution; immunocompetent patients with Ciclodan)8 -- -- -- -- -- mild to moderate onychomycosis of fingernails and toenails due to Trichophyton rubrum ciclopirox 8% / Topical treatment in triamcinolone acetonide* immunocompetent patients with (Trilociclo™)9 -- -- -- -- -- mild to moderate onychomycosis of fingernails and toenails due to Trichophyton rubrum clotrimazole For discomfort, scaly skin between (Alevazol [OTC], solution)10 X X X the toes or burning feet -- -- (RX only) Relief of itching, burning, and cracking clotrimazole Relief of itching, burning, and (Lotrimin® AF cream X X -- X -- cracking [OTC])11 clotrimazole / Caused by the organism betamethasone cream Trichophyton rubrum, Trichophyton X X -- X -- (DermacinRx Therazole mentagrophytes, and Pak)12,13 Epidermophyton floccosum clotrimazole / X X -- X -- -- betamethasone lotion14 econazole cream15 X X X X X -- econazole foam X -- -- -- -- -- (Ecoza®)16 econazole / triamcinolone acetonide* X X X X X -- (Triamazole™)17 * Contains an antifungal agent co-packaged with topical corticosteroid triamcinolone 0.1% ointment, which is indicated for the relief of inflammatory and pruritic manifestations of corticosteroids responsive dermatosis. Antifungals, Topical Review – November 2020 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Tinea Tinea Tinea Tinea Cutaneous Drug Other pedis cruris versicolor corporis candidiasis efinaconazole Topical treatment of 18 onychomycosis of the toenails due (Jublia®) -- -- -- -- -- to Trichophyton rubrum and Trichophyton mentagrophytes ketoconazole19 X X X X X Seborrheic dermatitis ketoconazole -- -- -- -- -- Seborrheic dermatitis (Extina®, Ketodan®)20,21 ketoconazole 2% shampoo22 -- -- X -- -- -- ketoconazole (Nizoral® A-D 1% shampoo -- -- -- -- -- Seborrheic dermatitis [OTC])23 ketoconazole (Xolegel®)24 -- -- -- -- -- Seborrheic dermatitis luliconazole Caused by the organism (Luzu™)25 X X -- X -- Trichophyton rubrum and Epidermophyton floccosum miconazole (Desenex® [OTC])26 X -- -- -- -- -- miconazole X -- -- X -- -- (Azolen™ [OTC])27 miconazole X -- -- X -- -- (Fungoid® [OTC])28 miconazole X X X X X -- (Lotrimin® AF spray [OTC])29 miconazole X X -- X -- -- (Mycozyl AP™ [OTC])30 miconazole X X -- -- -- -- (Zeasorb AF® [OTC])31 miconazole/zinc oxide/ Diaper dermatitis (adjunctive -- -- -- -- -- white petrolatum (Vusion®)32 treatment) 33 naftifine (Naftin®) X X -- X -- -- nystatin34 -- -- -- -- X -- nystatin/triamcinolone35 -- -- -- -- X -- oxiconazole X (cream X X X -- -- (Oxistat®)36 only) sertaconazole (Ertaczo®)37 X -- -- -- -- -- sulconazole X X X X -- -- (Exelderm®)38 tavaborole Topical treatment of 39 onychomycosis of the toenails due (Kerydin®) -- -- -- -- -- to Trichophyton rubrum or Trichophyton mentagrophytes Antifungals, Topical Review – November 2020 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Tinea Tinea Tinea Tinea Cutaneous Drug Other pedis cruris versicolor corporis candidiasis terbinafine X X X X -- -- (Lamisil® [OTC])40 terbinafine X X - X - -- (Lamisil® AT [OTC])41 tolnaftate X -- -- -- -- -- (Fungoid-D™ [OTC])42 tolnaftate X X X X -- -- (Tinactin® [OTC])43 tolnaftate X -- -- X -- -- (Lamisil AF Defense OTC])44 undecylenic acid -- X X -- X -- (Hongo Cura)45 undecylenic acid (Sponix® Anti-Fungal X X -- -- -- -- OTC])46 undecylenic acid/ Relief of itching, burning, and chloroxylenol X -- -- X -- cracking (Gordochom [OTC])47 Treatment of tinea versicolor requires a legend topical product while the treatment of tinea pedis, tinea cruris, or tinea corporis may be treated with an over-the-counter (OTC) topical agent. Manufacturer Listing Drug Manufacturer butenafine (Mentax) Mylan butenafine OTC (Lotrimin Ultra OTC) generic, Schering-Plough/Bayer ciclopirox (Ciclodan) Medimetriks ciclopirox (Loprox) generic, Medimetriks/Valeant ciclopirox generic ciclopirox/triamcinolone acetonide (Trilociclo) Puretek clotrimazole OTC (Lotrimin AF) generic; Schering-Plough/Bayer clotrimazole OTC (Alevazol) generic, Capital clotrimazole/betamethasone (Dermacinrx Therazole Pak) Puretek clotrimazole/betamethasone generic econazole generic econazole (Ecoza) Exeltis/Glenmark Antifungals, Topical Review – November 2020 Page 4 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. Manufacturer Listing (continued) Drug Manufacturer econazole /triamcinolone acetonide (Triamazole) Puretek efinaconazole (Jublia) Valeant ketoconazole generic ketoconazole (Extina, Ketodan) Mylan, Medimetriks ketoconazole 2% shampoo generic ketoconazole (Nizoral A-D 1% Shampoo [OTC]) Johnson & Johnson Consumer/Kramer ketoconazole (Xolegel) Aqua/Almirall luliconazole (Luzu) Oceanside, Valeant miconazole OTC generic miconazole (Azolen) OTC Stratus miconazole (Desenex) OTC GlaxoSmithKline Consumer miconazole (Fungoid) OTC Valeant/Pedinol miconazole (Lotrimin AF) OTC Schering-Plough/Bayer/MDS Consumer miconazole (Mycozyl AP) OTC Puretek miconazole (Zeasorb AF) OTC Crown miconazole/zinc oxide/white petrolatum (Vusion) Prestium/Mylan naftifine generic naftifine (Naftin) Sebela nystatin generic nystatin/triamcinolone generic oxiconazole generic oxiconazole (Oxistat) Sandoz sertaconazole (Ertaczo) Valeant sulconazole (Exelderm) generic; Sun/Journey tavaborole (Kerydin)48 generic, Pharmaderm/Sandoz terbinafine (Lamisil AT) OTC generic; Novartis/GSK tolnaftate (Fungoid-D) OTC Valeant tolnaftate (Tinactin) OTC Schering-Plough/Bayer tolnaftate (Lamisil AF) OTC Novartis/GSK tolnaftate OTC generic undecylenic acid (Hongo Cura) solution OTC Kramer undecylenic acid (Sponix Anti-Fungal) solution OTC BioRx undecylenic acid/chloroxylenol (Gordochom) solution OTC Gordon Products that are available as convenience kits are not included in this Therapeutic Class Review. Antifungals, Topical Review – November 2020 Page 5 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. OVERVIEW Tinea cruris, corporis, and pedis, named for the body sites involved, are superficial fungal infections (dermatophytosis) caused by 3 genera of dermatophytes: Trichophyton, Microsporum, and Epidermophyton.49 These dermatophytes are a homogenous group of fungi that live on the keratin of the stratum corneum, nails, and hair. The estimated lifetime risk of acquiring tinea infections is between 10% and 20%.50 Dryness of the skin’s outer layer discourages colonization by microorganisms and shedding of epidermal cells keeps many microbes from establishing residence.51 With inhibition or failure of the skin’s protective mechanisms, cutaneous infection may occur with subsequent pruritus, redness, and scaling. Since dermatophytes require keratin for growth, they are restricted to hair, nails, and superficial skin; therefore, most can be treated with topical antifungal medications. Tinea pedis (athlete’s foot) is 1 of the most common superficial fungal infections of the skin and is most often caused by the dermatophytes Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.52 Affected skin
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