Ordering & Access
There are no specific contraindications associated with the use of QUTENZA in people with a history of the conditions stated above. However, a patient’s history of past and current skin conditions should be evaluated and considered before treating with QUTENZA.1
QUTENZA should be used only on dry, intact (unbroken) skin. In patients treated for painful 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.1
Warnings and Precautions1
- Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others. Healthcare professionals should ensure that the recommended procedures and protective measures are used when administering QUTENZA.
- For healthcare professionals, wear nitrile gloves when administering QUTENZA and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.
- Do not apply QUTENZA to the patient’s face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching QUTENZA, or items exposed to capsaicin, and then touching the eyes and mucous membranes. If irritation of eyes or mucous membranes occurs, flush eyes and mucous membranes with cool water. Remove the affected individual (healthcare professional or patient) from the vicinity of QUTENZA.
- 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. Administer QUTENZA in a well-ventilated treatment area. Provide supportive medical care if shortness of breath develops. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. If respiratory irritation worsens or does not resolve, do not re-expose the affected healthcare professional or patient to QUTENZA.
- 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 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-existingsensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.
Application & Administration
- Before QUTENZA application, a physician or healthcare professional must identify and mark the painful area, including areas of hypersensitivity and allodynia.
- Pre-treat the identified area and surrounding 1 to 2 cm with a topical anesthetic to reduce discomfort. Remove anesthetic with a dry wipe; wash area with soap and water, drying skin thoroughly before applying QUTENZA.
- Apply QUTENZA to the previously identified areas by placing QUTENZA on skin, while slowly removing release liner from underneath.
- Remove QUTENZA by gently and slowly rolling the adhesive side inward.
- After removal of QUTENZA, apply the supplied Cleansing Gel for one minute, and then remove it with a dry wipe; wash area with soap and water.