Qutenza® (capsaicin) 8% patch Rx Only
BRIEF SUMMARY OF PRESCRIBING INFORMATION
(For complete prescribing information please see package insert.)
DESCRIPTION
Qutenza (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. The
capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in
chili peppers.
INDICATIONS AND USAGE
Qutenza is indicated for the management of neuropathic pain associated with postherpetic
neuralgia.
WARNINGS AND PRECAUTIONS
Eye and Mucous Membrane Exposure: Do not apply Qutenza to the face or scalp to avoid risk
of exposure to the eyes or mucous membranes.
Aerosolization of Capsaicin: Aerosolization of capsaicin can occur upon rapid removal of
Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive
side inward. If irritation of eyes or airways occurs, remove the affected individual from the
vicinity of Qutenza. Flush eyes and mucous membranes with cool water. Inhalation of airborne
capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of
breath develops.
Unintended Skin Exposure: If skin not intended to be treated comes in contact with Qutenza,
apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has
been wiped off, wash the area with soap and water.
Application-Associated Pain: Even following use of a local anesthetic prior to administration
of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain
during and following the application procedure with local cooling (such as an ice pack) and/or
appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform
potentially hazardous activities such as driving or operating machinery.
Increase in Blood Pressure: In clinical trials, increases in blood pressure occurred during or
shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some
patients had greater increases and these changes lasted for approximately two hours after
patch removal. Increases in blood pressure were unrelated to the pretreatment blood pressure
but were related to treatment-related increases in pain. Monitor blood pressure during the
treatment and provide adequate support for treatment-related pain.
Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or
cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider
these factors prior to initiating Qutenza treatment.
ADVERSE REACTIONS
The following serious adverse reactions are discussed in Warnings and Precautions: Application-Associated Pain and Increase in Blood Pressure.
Clinical Trials Experience: Across all controlled and uncontrolled trials, more than 1,600
patients have received Qutenza. A total of 394 patients received more than one treatment
application and 274 patients were followed for 48 weeks or longer. In controlled clinical studies,
98% of patients completed ≥ 90% of the intended patch application duration. Among patients
treated with Qutenza, 1% discontinued prematurely due to an adverse event.
Controlled Clinical Studies: Common Adverse Reactions: adverse reactions occurring in
≥ 5% of patients in the Qutenza group and at an incidence greater than in the control
group were application-site erythema, application-site pain, application-site pruritus and
application-site papules.
Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients
with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in
the control group. The majority of application-site reactions were transient and self-limited.
Transient increases in pain were commonly observed on the day of treatment in patients treated
with Qutenza. Pain increases occurring during patch application usually began to resolve after
patch removal. On average, pain scores returned to baseline by the end of the treatment day
and then remained at or below baseline levels. A majority of Qutenza-treated patients in clinical
studies had adverse reactions with a maximum intensity of “mild” or “moderate.”
TABLE 1:
Treatment-emergent adverse reaction incidence (%) in controlled trials in
postherpetic neuralgia (events in ≥ 1% of Qutenza-treated patients and at least 1%
greater in the Qutenza group than in the control group)
Body System
Preferred Term
Qutenza
60 minutes
(N = 622)
%
Control
60 minutes
(N = 495)
%
GENERAL DISORDERS AND ADMINISTRA TION-SI TE CONDITIONS
Application-Site Erythema
Application-Site Pain
Application-Site Pruritus
Application-Site Papules
Application-Site Edema
Application-Site Swelling
Application-Site Dryness
Infections and Infestations
Nasopharyngitis
Bronchitis
Sinusitis
Gastrointestinal Disorders
Nausea
Vomiting
Skin and Subcutaneous Tissue Disorder
Pruritus
Vascular Disorders
Hypertension
63
42
6
6
4
2
2
54
21
4
3
1
1
1
4
2
3
2
1
1
5
3
2
1
2
< 1
2
1
Other Adverse Reactions Observed During the Clinical Studies of Qutenza: General
Disorders and Administration-Site Conditions: application-site urticaria, application-site
paresthesia, application-site dermatitis, application-site hyperesthesia, application-site
excoriation, application-site warmth, application-site anesthesia, application-site bruising,
application-site inflammation, application-site exfoliation, peripheral edema
Nervous System Disorders: headache, burning sensation, peripheral sensory neuropathy,
dizziness, dysgeusia, hyperesthesia, hypoesthesia
Respiratory, Thoracic, and Mediastinal Disorders: cough, throat irritation
Skin and Subcutaneous Tissue Disorders: abnormal skin odor
DRUG INTERACTIONS
No clinical drug interaction studies have been performed.
Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does
not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed
those measured in blood samples. Therefore, interactions with systemic medicinal products
are unlikely.
USE IN SPECIFIC POPULATIONS
Pregnancy - Category B
There are no adequate and well-controlled studies evaluating Qutenza in pregnant women.
There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies
conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were
applied once daily for a 3-hour duration during the period of fetal organogenesis up to doses
corresponding to an 11-fold margin over the maximum recommended human dose [MRHD]
based on a Cmax exposure comparison. A peri- and post-natal reproduction toxicology study
in rats showed no effects on survival, growth, learning and memory tests, sexual maturation,
mating, pregnancy, and fetal development in the offspring of mothers treated with capsaicin
up to an 11-fold margin over the MRHD.
Labor and Delivery: The effects of Qutenza on labor and delivery are unknown.
Nursing Mothers: There are no adequate and well-controlled studies in nursing women.
Studies in rats have demonstrated capsaicin is excreted into breast milk of this species. It
is unknown whether capsaicin is excreted in human breast milk. Because Qutenza is
administered as a single 60-minute application and capsaicin is rapidly cleared from the
bloodstream, mothers can reduce infant exposure by not breast-feeding after treatment
on the day of treatment.
Pediatric Use: The safety and effectiveness of Qutenza in patients younger than 18 years of
age have not been studied.
Geriatric Use: In controlled clinical studies of Qutenza in neuropathic pain associated with
postherpetic neuralgia, 75% of patients were 65 years and older and 43% of patients were 75
years and older. Safety and effectiveness were similar in geriatric patients and younger patients.
No dose adjustments are required in geriatric patients.
OVERDOSAGE
There is no clinical experience with Qutenza overdose in humans.
There is no specific antidote for overdose with capsaicin. In case of suspected overdose,
remove patches gently, apply Cleansing Gel for one minute, wipe off with dry gauze and
gently wash the area with soap and water. Use supportive measures and treat symptoms as
clinically warranted.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility: Adequate carcinogenicity studies
have not been conducted with Qutenza or capsaicin. Capsaicin was not mutagenic in the Ames,
mouse micronucleus and chromosomal aberration in human peripheral blood lymphocytes
assays. As with other catechol-containing compounds (eg, dopamine), capsaicin showed a
weak mutagenic response in the mouse lymphoma assay. A fertility and reproductive toxicology
study was conducted in rats with exposure to Qutenza patches daily for 3 hours/day beginning
28 days before cohabitation, through cohabitation and continuing through the day before
sacrifice (approximately 49 days of treatment). The results revealed a statistically significant
reduction in the number and percent of motile sperm. Sperm motility obtained from the vas
deferens was reduced in all capsaicin treatment groups ( 16, 24, and 32 mg capsaicin patch/rat/
day). Though a “no effect” level was not determined, dose levels used in the study correspond
to a 13- to 28-fold exposure margin over the mean Cmax associated with the maximal human
recommended dose. Sperm counts were reduced in the vas deferens or cauda epididymis in
the 24 and 32 mg capsaicin patch/rat/day dose groups ( 79 and 69%, respectively) compared to
the placebo-patch-treated control group; however, these reductions did not adversely affect
fertility. As this animal model has a large excess of sperm-generating capacity relative to the
threshold necessary for fertilization, the lack of an effect on fertility in this species is of unknown
significance for human risk assessment.
DOSAGE AND ADMINIS TRATION
Special precautions: • Only physicians or health care professionals under the close supervision
of a physician are to administer Qutenza. • Use only nitrile gloves when handling Qutenza,
and when cleaning capsaicin residue from the skin. • Immediately after use, dispose of used
and unused patches, cleansing gel, and other treatment materials in accordance with the local
biomedical waste procedures. • Use Qutenza only on dry, intact (unbroken) skin.
Dosing: The recommended dose of Qutenza is a single, 60-minute application of up to four
patches. Treatment with Qutenza may be repeated every three months or as warranted by the
return of pain (not more frequently than every three months).
HANDLING AND DISPOSAL
Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory
tract, and mucous membranes. Do not dispense Qutenza to patients for self-administration. It
is critical that health care professionals who administer Qutenza have completely familiarized
themselves with proper dosing, handling, and disposal procedures before handling Qutenza to
avoid accidental or inadvertent capsaicin exposure to themselves or others [see Dosage
and Administration].
Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in
contact with the treatment area without wearing nitrile gloves. Wear nitrile gloves at all times
while handling Qutenza and cleaning treatment areas. Do NOT use latex gloves. Do not
hold Qutenza near eyes or mucous membranes. Immediately after use, dispose of used and
unused patches, patch clippings, unused Cleansing Gel, and associated treatment supplies in
accordance with local biomedical waste procedures.
PATIENT COUNSELING INFORMATION
See Patient Counseling Information section of the full package insert.
Manufactured for NeurogesX, Inc., San Mateo, CA 94404, USA by Lohmann Therapie-Systeme
AG (LTS), Andernach, Germany
www.Qutenza.com
Qutenza® is a registered trademark of NeurogesX, Inc.
© NeurogesX, Inc. 2010
Rev. November 2009
109270-1
