demonstrated in treating nail low incidence of fungus ... · subject a subject b baseline 40% week...

Subject A Subject B Baseline 40% Week 24 15% Week 52 0% Baseline 45% Week 24 10% Week 52 5% THE #1 DISPENSED NAIL FUNGUS TREATMENT IN CANADA * Demonstrated low incidence of adverse reactions † • Total number of patients who reported a treatment-emergent adverse reaction was 6.1% JUBLIA TM , 3.5% vehicle • The only treatment-emergent adverse reactions reported by ≥ 1% of patients were application site dermatitis (2.0% JUBLIA TM , 0.2% vehicle) and application site vesicles (1.4% JUBLIA TM , 0.0% vehicle) Indicated for the topical treatment of mild to moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and Trichophyton mentagrophytes in immunocompetent adult patients. Demonstrated results in treating nail fungus topically † Almost complete cure § (secondary endpoint) Complete cure ‡ (primary endpoint) JUBLIA TM is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Canada LP, 2150 St-Elzéar Blvd. West Laval, Quebec H7L 4A8 © 2017 Valeant Canada LP. All rights reserved. valeantcanada.com CLINICAL USE: Safety and efficacy in patients under 18 or over 75 have not been studied. Greater sensitivity of some older individuals ( ≥65) cannot be ruled out. CONTRAINDICATIONS: • Hypersensitivity to efinaconazole or any excipients of JUBLIA TM or container component RELEVANT WARNINGS AND PRECAUTIONS: • Patients with a history or clinical signs of immunosuppression, HIV infection, uncontrolled diabetes, other toenail infection except Candida, toenail infection to the matrix, only lateral toenail disease, severe plantar tinea pedis • Concomitant use of other antifungal therapy and daily use of JUBLIA TM for more than 48 weeks • For topical use only, and only on toenails and immediately adjacent skin • Flammable – keep away from heat or flame • Sensitivity reaction or severe irritation • Pregnant and nursing women FOR MORE INFORMATION: Please see Product Monograph on the Health Canada website (http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp) for important information on adverse reactions, drug interactions and dosing. Product Monograph is also available by calling 1-800-361-4261. * Source: IMS Brogan CompuScript Audit, January 2017. † Two identical 48-week, randomized, double-blind, vehicle-controlled trials with 4-week post follow-up in 1,601 patients (1,198 JUBLIA TM , 403 vehicle) with 20-50% clinical involvement of area of target great toenail, without dermatophytomas or lunula (matrix) involvement. Patients not excluded for concomitant Candida infection. ‡ Defined as 0% clinical involvement of target toenail plus mycologic cure. § Defined as ≤5% clinical involvement of target toenail plus mycologic cure. REFERENCES: 1. JUBLIA TM Product Monograph, October 2013. 2. Elewski BE, Rich P, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies. J Am Acad Dermatol 2013;Vol 68, No 4:600-608. Representative clinical photographs of two patients with moderate onychomycosis. Patient counselling tips • Use JUBLIA TM for the full treatment period recommended by the doctor • Stopping JUBLIA TM too soon may cause the infection to restart • Treatment may take several months to work so don’t expect the infection to clear up quickly • Apply one drop to affected toenail(s) and two drops to affected big toenail(s) once daily, preferably at bedtime • Fungal infections like onychomycosis can be difficult to clear up. Even when treated it can take 12 to 18 months for the infected nail to grow out • Avoid nail polish, cosmetic nail products, or pedicures from a non-healthcare professional while using JUBLIA TM • It is important to refill your prescription on time, so you don’t miss any applications NEW FORMAT 33% MORE

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Subject A Subject B

Baseline

40%

Week 24

15%

Week 52

Baseline

45%

Week 24

10%

Week 52

THE #1 DISPENSED NAIL FUNGUS TREATMENT IN CANADA*

Demonstratedlow incidence of adverse reactions†

• Total number of patients who reported a treatment-emergent adverse reaction was 6.1% JUBLIATM, 3.5% vehicle

• The only treatment-emergent adverse reactions reported by ≥1% of patients wereapplication site dermatitis (2.0% JUBLIATM, 0.2% vehicle) and application site vesicles(1.4% JUBLIATM, 0.0% vehicle)

Indicated for the topical treatment of mild to moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and Trichophyton mentagrophytes in immunocompetent adult patients.

Demonstrated resultsin treating nailfungus topically†

Almostcomplete cure§

(secondary endpoint)

Completecure‡

(primary endpoint)

JUBLIATM is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

Valeant Canada LP, 2150 St-Elzéar Blvd. WestLaval, Quebec H7L 4A8

valeantcanada.com

CLINICAL USE:Safety and effi cacy in patients under 18 or over 75 havenot been studied. Greater sensitivity of some older individuals (≥65) cannot be ruled out.

CONTRAINDICATIONS:• Hypersensitivity to efi naconazole or any excipients of

JUBLIATM or container component

RELEVANT WARNINGS AND PRECAUTIONS:• Patients with a history or clinical signs of immunosuppression,

HIV infection, uncontrolled diabetes, other toenail infection except Candida, toenail infection to the matrix, only lateral toenail disease, severe plantar tinea pedis

• Concomitant use of other antifungal therapy and daily useof JUBLIATM for more than 48 weeks

• For topical use only, and only on toenails and immediately adjacent skin

• Flammable – keep away from heat or fl ame• Sensitivity reaction or severe irritation• Pregnant and nursing women

FOR MORE INFORMATION:Please see Product Monograph on the Health Canada website (http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp) for important information on adverse reactions, drug interactions and dosing. Product Monograph is also available by calling 1-800-361-4261.

* Source: IMS Brogan CompuScript Audit, January 2017.

† Two identical 48-week, randomized, double-blind, vehicle-controlled trials with 4-week post follow-up in 1,601 patients (1,198 JUBLIATM, 403 vehicle) with 20-50% clinical involvement of area of target great toenail, without dermatophytomas or lunula (matrix) involvement. Patients not excludedfor concomitant Candida infection.

‡ Defi ned as 0% clinical involvement of target toenail plus mycologic cure.

§ Defi ned as ≤5% clinical involvement of target toenail plus mycologic cure.

REFERENCES: 1. JUBLIATM Product Monograph, October 2013.2. Elewski BE, Rich P, et al. Efi naconazole 10% solution in the treatmentof toenail onychomycosis: Two phase III multicenter, randomized,double-blind studies. J Am Acad Dermatol 2013;Vol 68, No 4:600-608.

Representative clinical photographs of two patients with moderate onychomycosis.

Patient counselling tips• Use JUBLIATM for the full treatment period

recommended by the doctor

• Stopping JUBLIATM too soon may causethe infection to restart

• Treatment may take several months towork so don’t expect the infection toclear up quickly

• Apply one drop to affected toenail(s) andtwo drops to affected big toenail(s) once daily, preferably at bedtime

• Fungal infections like onychomycosis canbe diffi cult to clear up. Even when treatedit can take 12 to 18 months for the infected nail to grow out

• Avoid nail polish, cosmetic nail products,or pedicures from a non-healthcare professional while using JUBLIATM

• It is important to refi ll your prescriptionon time, so you don’t miss any applications

NEWFORMAT

33% MORE

toe nail fungus treatment