WARNINGS
Treatment with QUTENZA must be performed only by a healthcare provider. Never apply or remove QUTENZA yourself.
Do not touch QUTENZA or items exposed to capsaicin. Touching QUTENZA and then accidentally touching other areas of your body can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin.
Do not touch your eyes or other unintended target areas during the QUTENZA application. QUTENZA is not for use near eyes or mucous membranes. Do not sniff or inhale near QUTENZA as this may cause you to cough or sneeze. If irritation of eyes or airways occurs or any side effects become severe, notify your doctor immediately.
You may experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain; a cool compress or medicine for the pain can be provided to help lessen your discomfort. You may get frostbite if you cool your skin too much. You can use a cooling pack from the refrigerator (not the freezer) and avoid putting it directly on skin.
Seek medical attention if you experience strong and continuous pain or skin lesions such as blisters after treatment.
Tell your doctor if you have reduced sensation in the feet. You may notice that you have less feeling for hot or sharp pain where QUTENZA was applied, but this is usually minor and temporary.
Treated areas may be sensitive to heat (e.g., hot water, direct sunlight, vigorous exercise) for a few days after treatment.
1.) Severe Irritation with Unintended Capsaicin Exposure
Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others. Ensure that the recommended procedures and protective measures are used when administering QUTENZA.
Eye and Mucous Membrane Exposure
For healthcare professionals:
o 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.
o Use of a face mask and protective glasses is advisable.
• 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.
Respiratory Tract Exposure
• 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 (healthcare professional or patient) 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.
Skin Exposure
• 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.
Thoroughly clean all areas that had contact with QUTENZA and properly dispose of QUTENZA, associated packaging, Cleansing Gel, gloves, and other treatment materials in accordance with local biomedical waste procedures.
2.) Application-Associated Pain
Even following use of a local anesthetic prior to administration of QUTENZA, patients may experience substantial procedural pain and burning upon application of QUTENZA and following removal of QUTENZA.
Prepare to treat acute pain during and following the application procedure with local cooling and/or appropriate analgesic medication.
3.) Increase in Blood Pressure
In clinical trials, transient increases in blood pressure occurred during or shortly after exposure to QUTENZA.
The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after QUTENZA removal. Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure
USES
QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
HOW TO USE
Please call your healthcare provider for more information.
QUTENZA can cause serious side effects, including pain, severe burns, and increases in blood pressure during or right after treatment. Your healthcare provider should check your blood pressure during treatment with QUTENZA. If you have high blood pressure that is not well controlled by medicine, or have had recent heart problems, stroke, or other vascular problems, you may be at increased risk and should discuss with your doctor whether QUTENZA is right for you.
None.
OVERDOSE
There is no clinical experience with QUTENZA overdose in humans.
There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove QUTENZA gently, apply Cleansing Gel for one minute, wipe off with dry gauze, and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store carton between 20-degrees C to 25-degrees C (68-degrees F to 77-degrees F). Excursions between 15-degrees C and 30-degrees C (59-degrees F and 86-degrees F) are allowed.
Keep QUTENZA in the sealed pouch until immediately before use.
NOTES
Medication Guide: revision date N/A
Prescribing Information: revision date 07/2024
No clinical drug interaction studies have been performed.
Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples.
Therefore, interactions with systemic medicinal products are unlikely.
Please call your healthcare provider for more information.
