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Targeting Nerve Fibers Associated with Painful Diabetic Peripheral Neuropathy of the Feet

Program Information

Targeting Nerve Fibers Associated with Painful Diabetic Peripheral Neuropathy of the Feet
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What’s the pharmacology of a unique patch technology that can be used to treat painful diabetic peripheral neuropathy of the feet?

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  • Overview

    Thanks to recent advancements, we’re now able to treat painful diabetic peripheral neuropathy of the feet locally using a unique patch technology. Learn more about this unique technology’s mechanism of action with Dr. Jeffrey Fudin.

    QUTENZA® is a registered trademark of Averitas Pharma, Inc.
    © 2020 Averitas Pharma, Inc. All rights reserved.
    M-QZA-US-10-20-0023 October 2020

  • Important Safety Information

    Select Safety Information

    • Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle QUTENZA.
    • Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. When administering QUTENZA, it is important to follow the procedures in the Important Dosage and Administration Instructions in the USPI.
    • In patients treated for neuropathic pain associated with diabetic peripheral neuropathy, a careful examination of the feet should be undertaken prior to each application of QUTENZA to detect skin lesions related to underlying neuropathy or vascular insufficiency.

    Contraindications

    • None

    Warnings and Precautions

    • Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. Provide supportive medical care if shortness of breath develops.
    • If skin not intended to be treated is exposed to 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.
    • Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling (such as a cold pack) and/or appropriate analgesic medication.
    • Transient increases in blood pressure may occur during and shortly after the QUTENZA treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate 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.
    • Reductions in sensory function have been reported following administration of QUTENZA. Decreases in sensory function are generally minor and temporary. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.

    Adverse Reactions

    • In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.

    For additional information, please see the full Prescribing Information, including Patient Information.

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Programs 12/3/20