Not an actual patient.
QUTENZA Combines a Unique Mechanism of Action (MOA) and Matrix System Technology1-4
The matrix system technology uniquely and rapidly delivers concentrated capsaicin at the source of the pain.
QUTENZA treats pain differently by directly targeting TRPV1‑expressing fibers responsible for the pain associated with diabetic peripheral neuropathy (DPN) of the feet.
QUTENZA creates a forced diffusion of high-concentration capsaicin that penetrates the epidermal layers and activates the TRPV1 receptors.
Overstimulation of these receptors causes a desensitization of the TRPV1-expressing fibers, suspending pain signals to the brain.
QUTENZA triggers a chemical cascade that results in reversible ablation of the TRPV1-expressing fibers.
The chemical ablation temporarily destroys these fibers, preventing the transmission of pain signals and providing significant and sustained relief.
TRPV1-expressing fibers regenerate and reinnervate, resulting in the return of pain.
QUTENZA can provide lasting pain relief with just one treatment every 3 months.
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.