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 * Prescribing Information
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QUTENZA. For ongoing and sustained pain relief.1


QUTENZA FOR PAINFUL DPN OF THE FEET 

DPN: diabetic peripheral neuropathy.

Not an actual patient.


QUTENZA FOR NEUROPATHIC PAIN ASSOCIATED WITH PHN 

PHN: postherpetic neuralgia.

Not an actual patient.



Non-surgical1



 * Topical treatment

Treatment
flexibility1



 * Can be used alone or in combination
 * No known drug-drug interactions
 * No additional pill burden

Low risk for systemic side effects1



 * Localized
 * Non-systemic
 * Non-opioid
 * No contraindications

Low discontinuation rates1



 * 1% of QUTENZA patients discontinued in clinical studies due to an adverse
   event

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INDICATION

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment
of neuropathic pain associated with postherpetic neuralgia (PHN) or associated
with diabetic peripheral neuropathy (DPN) of the feet.

IMPORTANT SAFETY INFORMATION

Do not dispense QUTENZA to patients for self‑administration or handling. Use
only on dry, unbroken skin. Only physicians or healthcare professionals are to
administer and handle QUTENZA, following the procedures in the label.

Warnings and Precautions

 * Severe Irritation: Whether applied directly or transferred accidentally from
   other surfaces, capsaicin can cause severe irritation of eyes, mucous
   membranes, respiratory tract, and skin to the healthcare professional,
   patients, and others. Do not use near eyes or mucous membranes, including
   face and scalp. Take protective measures, including wearing nitrile gloves
   and not touching items or surfaces that the patient may also touch. Flush
   irritated mucous membranes or eyes with water and provide supportive medical
   care for shortness of breath. Remove affected individuals from the vicinity
   of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory
   irritation worsens or does not resolve. If skin not intended to be treated
   comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with
   dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and
   dispose of properly. Because aerosolization of capsaicin can occur with rapid
   removal, administer QUTENZA in a well‑ventilated area, and remove gently and
   slowly, rolling the adhesive side inward.
 * Application-Associated Pain: Patients may experience substantial procedural
   pain and burning upon application and following removal of QUTENZA. Prepare
   to treat acute pain during and following application with local cooling
   (e.g., ice pack) and/or appropriate analgesic medication.
 * Increase in Blood Pressure: Transient increases in blood pressure may occur
   with QUTENZA treatment. Monitor blood pressure during and following treatment
   procedure and provide support for treatment‑related pain. Patients with
   unstable or poorly controlled hypertension, or 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.
 * Sensory Function: Reductions in sensory function (generally minor and
   temporary) have been reported following administration of QUTENZA. All
   patients with sensory deficits should be assessed for signs of sensory
   deterioration or loss prior to each application of QUTENZA. If sensory loss
   occurs, treatment should be reconsidered.

Adverse Reactions

The most common adverse reactions (≥5% and > control group) in all controlled
clinical trials are application site erythema, application site pain, and
application site pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at
1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment
of neuropathic pain associated with postherpetic neuralgia (PHN) or associated
with diabetic peripheral neuropathy (DPN) of the feet.

IMPORTANT SAFETY INFORMATION

Do not dispense QUTENZA to patients for self‑administration or handling. Use
only on dry, unbroken skin. Only physicians or healthcare professionals are to
administer and handle QUTENZA, following the procedures in the label.

Warnings and Precautions

 * Severe Irritation: Whether applied directly or transferred accidentally from
   other surfaces, capsaicin can cause severe irritation of eyes, mucous
   membranes, respiratory tract, and skin to the healthcare professional,
   patients, and others. Do not use near eyes or mucous membranes, including
   face and scalp. Take protective measures, including wearing nitrile gloves
   and not touching items or surfaces that the patient may also touch. Flush
   irritated mucous membranes or eyes with water and provide supportive medical
   care for shortness of breath. Remove affected individuals from the vicinity
   of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory
   irritation worsens or does not resolve. If skin not intended to be treated
   comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with
   dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and
   dispose of properly. Because aerosolization of capsaicin can occur with rapid
   removal, administer QUTENZA in a well‑ventilated area, and remove gently and
   slowly, rolling the adhesive side inward.
 * Application-Associated Pain: Patients may experience substantial procedural
   pain and burning upon application and following removal of QUTENZA. Prepare
   to treat acute pain during and following application with local cooling
   (e.g., ice pack) and/or appropriate analgesic medication.
 * Increase in Blood Pressure: Transient increases in blood pressure may occur
   with QUTENZA treatment. Monitor blood pressure during and following treatment
   procedure and provide support for treatment‑related pain. Patients with
   unstable or poorly controlled hypertension, or 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.
 * Sensory Function: Reductions in sensory function (generally minor and
   temporary) have been reported following administration of QUTENZA. All
   patients with sensory deficits should be assessed for signs of sensory
   deterioration or loss prior to each application of QUTENZA. If sensory loss
   occurs, treatment should be reconsidered.

Adverse Reactions

The most common adverse reactions (≥5% and > control group) in all controlled
clinical trials are application site erythema, application site pain, and
application site pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at
1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.



Carton with one topical system + Cleansing Gel: NDC #72512-928-01
Carton with two topical systems + Cleansing Gel: NDC #72512-929-01
Carton with four topical systems + Cleansing Gel: NDC #72512-930-01



Reference:

1.QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc.

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© 2023 Averitas Pharma, Inc. All rights reserved.
QZA-03-22-0029 v7.0 August 2023



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