Not an actual patient.
Safety Profile for QUTENZA1
All adverse reactions, regardless of causality, occurring in >1% of patients with painful diabetic peripheral neuropathy (DPN) of the feet in the QUTENZA group for which the incidence was at least 1% greater than in the control group.
Adverse reaction incidence (%) in double-blind controlled trials in neuropathic pain associated with diabetic peripheral neuropathy (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
30 minutes
(N=186)
%
Control
30 minutes
(N=183)
%
General Disorders and Administration Site Conditions
Application site reactions
Injury, Poisoning, and Procedural Complications
Musculoskeletal and Connective Tissue Disorders
Nervous System Disorders
Respiratory, Thoracic, and Mediastinal Disorders
Upper respiratory symptoms
Vascular Disorders
Less common adverse reactions (<1%) with QUTENZA, observed during DPN clinical trials included: dizziness, dysesthesia, blister.
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post approval use of QUTENZA: second- and third-degree burns and scarring; accidental exposure (including eye pain, cough, eye and throat irritation).
The most common adverse reactions were transient and self-limited.1
QUTENZA has a favorable safety profile with no systemic drug-drug interactions1
Treatment flexibility
- QUTENZA can be used alone or in combination
Low risk for systemic side effects
- QUTENZA is non-systemic
- QUTENZA is non-opioid
- QUTENZA has no contraindications
Low discontinuation rates
- 1% of QUTENZA patients discontinued in clinical studies due to an adverse event
Patients may experience the following1:
- Pain at treatment site, which can be treated with a cooling pack or appropriate analgesic medication, if needed
- Transient increase in blood pressure
- Sensitivity to heat (eg, during showers, sunlight exposure, vigorous exercise) for a few days
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
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
Please see full Prescribing Information.