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Frequently Asked Questions About QUTENZA
About QUTENZA
What medications are used to treat diabetic nerve pain of the feet and
What is QUTENZA?
What are the most common side effects of QUTENZA?
The most common side effects are redness, pain, or itching on the skin where QUTENZA was applied.
Please see additional Important Safety Information.
Why does QUTENZA have to be applied by my doctor or other healthcare professional?
QUTENZA contains prescription-strength capsaicin capable of producing severe irritation of the eyes, mucous membranes, respiratory tract, and skin. Only a doctor or healthcare professional under the close supervision of a doctor is to administer and handle QUTENZA. While administering QUTENZA, nitrile gloves are required and must be disposed of properly to prevent accidental contact.
Your blood pressure may be monitored periodically during and following treatment because pain during the treatment may cause your blood pressure to increase.
Tell your doctor or healthcare professional if you have experienced any recent heart problems prior to QUTENZA treatment.
What should I discuss with my doctor or healthcare professional before my QUTENZA treatment?
Tell your doctor or healthcare professional if you:
Have high blood pressure that is not well controlled by medicine, or have had recent heart problems, stroke, or other vascular problems.
Your doctor or healthcare professional may monitor your blood pressure periodically during and following treatment.
What to Expect During QUTENZA Treatment
Will I experience pain during my QUTENZA treatment?
Some pain and burning during and following treatment can occur due to the prescription-strength capsaicin in QUTENZA. In clinical trials, on average, pain improved for most patients by the end of the treatment day. Pain increases that occurred during QUTENZA treatment usually began to decrease after QUTENZA removal.
It's important that you tell your doctor or healthcare professional how you are feeling during treatment. If you experience pain, tell your doctor or healthcare professional. Your healthcare professional may use cold packs or pain medicine to reduce treatment-related discomfort.
Also, because treatment-related pain may cause an increase in blood pressure, your doctor or healthcare professional may monitor your blood pressure periodically during and following treatment.
What else should I know about QUTENZA?
Do not touch QUTENZA during treatment, as this may irritate your eyes, mucous mebranes, respiratory tract, and skin.
The areas treated with QUTENZA may be sensitive to heat, so you may wish to avoid hot showers or baths, direct sunlight, and vigorous exercise for a few days following treatment.
INDICATION
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. You should never apply or remove QUTENZA yourself.
Contraindications
None
Warnings and Precautions
- 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.
- 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 any of these side effects become severe, tell your healthcare provider immediately.
- Even though a numbing medicine is used on the skin before applying QUTENZA, some patients may still 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.
- QUTENZA can cause serious side effects, including pain 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.
- 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.
Side Effects
In all clinical trials, the most common drug-related side effects of QUTENZA were redness, pain, or itching where QUTENZA was applied. You should tell your doctor if any side effects bother you or do not go away.
Adverse Event Reporting
Physicians, other healthcare providers, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can:
- In the US, visit or call
1-800-FDA-1088; or - For QUTENZA, you may also call 1-877-900-6479 and select option 1, or press zero on your keypad to talk to an operator to direct your call.
For more information, ask your healthcare provider or pharmacist.
Please see full Prescribing Information.