CDA Essentials 2015 • Volume 2 • Issue 6 - page 36

PRESCRIBEXERESE TM ANDHELP
ST PCOLD SORES FROMULCERATING
42%ofXERESETM patientsdidnot developanulcerative lesionvs. acyclovir 5% cream
(35%, p=0.014) andvs. vehicle (26%, p<0.0001)1,2†
• Apredefined level of significance ( p<0.001) for the comparisonbetweenXERESETM andacyclovirwas not achieved
XERESETM is theonly topical prescription treatment indicated to reduce
cold soreprogression:1*
• Indicated for the treatment of early signs and symptoms of recurrent herpes labialis to reduce
theprogressionof cold soreepisodes toulcerative lesions in immunocompetent adults and
adolescents ≥12 years
valeantcanada.com
CLINICALUSE:
• Safety and efficacy in patients>65 years have not been determined conclusively
• Safety and effectiveness in children<12 years have not been established
CONTRAINDICATIONS:
• Patientswith known or suspected history of hypersensitivity to valacyclovir
RELEVANTWARNINGSANDPRECAUTIONS:
• Use only cutaneously for recurrent herpes labialis on the lips and around themouth
and nowhere else
• Not recommended for application tomucousmembrane: not to be used in or near
the eyes, inside themouth or nose, on the genitals, or rectal area
• Seekmedical advice if no improvement is notedwith2weeks of treatment of orofacial
lesions (e.g. bacterial and fungal infection) not distinguishable from a cold sore
• Possibility of significant acyclovir viral resistance
• Caution in patientswith stasis dermatitis and other skin diseases associated
with impaired circulation
• Caution inpregnant women: it is not knownwhether XERESETM can cause fetal harm
or affect reproductive capacity
• Caution innursingwomen: potential for serious adverse reactions innursing infants
• Manifestations of Cushing’s syndrome and reversible HPA axis suppression
• Hypersensitivity reactions
• May increase the risk of skin infections
• Should not be used in severely immunocompromised patients
FORMORE INFORMATION:
Please see Product Monograph at webprod5.hc-sc.gc.ca/dpd-bdpp/
index-eng.jsp for important information relating to adverse reactions,
drug interactions and dosing information which have not been
discussed in this piece. The Product Monograph is also available
by calling 1-800-361-4261.
* Comparative clinical significance not established.
†Randomized, double-blind, active- and vehicle-controlled, subject-initiated 5-day
trial of 1443 immunocompetent adults ≥18 yearswith ≥3 herpes labialis episodes
in the previous year, prodromal symptoms in ≥50% of episodes and ulcerative
lesions in ≥75% of episodes. XERESETM n=601, acyclovir n=610, vehicle n=232.
REFERENCES: 1. XERESE TM Product Monograph, March 2013
2. Hull CM, Harmenberg J et al. Early treatment of cold soreswith topical ME-609
decreases the frequency of ulcerative lesions: A randomized, double-blind,
placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol 2011;
Vol. 64, Issue 4, 696.e1-696.e11.
HELPSSTOPCOLDSORES
FROMULCERATING
XERESETM is a trademark of Meda Pharma SARL used under license.
Valeant Canada LP, 2150St-Elzéar Blvd.West, Laval, Quebec H7L 4A8
© 2015 Valeant Canada LP. All rights reserved.
FORPATIENTSWHO
DEVELOPCOLDSORES
XERESETM