QUTENZA® (capsaicin) 8% topical system 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.
IMPORTANT SAFETY INFORMATION
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.
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.
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.
The most common side effects of QUTENZA are redness, pain, or itching where QUTENZA was applied. You should tell your doctor if any side effects bother you or do not go away.
To report suspected adverse reactions, contact Averitas Pharma, Inc. at 1-877-900-6479 (Option 1) or FDA at 1-800-FDA-1088 or .
For more information, ask your healthcare provider or pharmacist.
