Summary of "QUTENZA® Application Video"

  • Target Condition and Treatment: QUTENZA® is designed for diabetic nerve pain in the feet, offering up to 3 months of relief with a single 30-minute application by a healthcare provider.

  • Application Process: The treatment involves checking blood pressure, discussing pain areas, cleaning the feet, applying patches, and securing them with gauze or bandages.

  • Post-Application Care: After removal of the patches, a cleansing gel is applied, followed by washing and drying the feet. Patients should avoid heat and vigorous activities for a few days post-treatment.

  • Safety Information: QUTENZA must be applied by a healthcare provider due to potential serious side effects like irritation and increased blood pressure. Patients should avoid contact with eyes and mucous membranes.

  • Side Effects and Reporting: Common side effects include redness and pain at the application site. Patients should report any adverse reactions to their doctor or the appropriate health authorities.

Did You Know

QUTENZA® application process is that it uses a patch containing capsaicin, the active ingredient derived from chili peppers, which is effective in reducing nerve pain by depleting a specific neuropeptide involved in pain transmission. This unique approach provides a non-invasive alternative to traditional pain relief methods.

Transcript

Many people with diabetes suffer from diabetic nerve pain in their feet, which can impact their day-to-day life. Cenza is a treatment specifically developed to target diabetic nerve pain. When applied by your healthcare provider, one 30-minute treatment can offer up to 3 months of pain relief. For ongoing relief, Cenza is applied up to four times per year.

Now, we’re ready to begin the application. Your blood pressure will be checked during and after treatment. You and your healthcare provider will discuss where you're experiencing pain in your feet before Cenza is applied. Your feet will be washed, dried, and examined to make sure your skin is free from any cuts or open wounds. If needed, a numbing agent can be used before treatment begins.

The Cenza patches may be cut to cover the areas where you're experiencing pain. Once the area of pain is completely covered, rolled gauze or a self-adhesive bandage will be used to ensure that Cenza stays in contact with the skin. Your healthcare provider will now set the timer for 30 minutes. You may feel a slow warming or burning sensation during the application—this is normal.

Once the 30 minutes are up, the Cenza patches will be removed. To eliminate any residue, a special Cenza topical cleansing gel will be applied and left on for 1 minute. After the gel is completely removed, your feet will be gently washed and dried. When your feet are dry, you're ready to put on your socks and shoes and make your next appointments. Once you are home, wash your feet again and put on clean socks.

Your feet may be sensitive to heat for one or two days following the application. Avoid hot showers, baths, direct sunlight, and vigorous exercise. If you have any discomfort, apply an ice pack or take an over-the-counter pain medication. Treatment with Cenza may offer up to 3 months of relief from diabetic nerve pain and can be applied up to four times a year. Be sure to schedule your next appointment before you leave to ensure ongoing relief.

Important Safety Information:

Indication:
Cenza capsaicin 8% topical system is indicated in adults for the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) of the feet.

Important Safety Information:
Treatment with Cenza must only be performed by a healthcare provider. You should never apply or remove Cenza yourself. Do not touch Cenza or items exposed to capsaicin, as touching these and then accidentally touching other areas of your body can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Avoid touching your eyes or other unintended areas during the Cenza application.

Cenza is not for use near eyes or mucous membranes. Do not sniff or inhale near Cenza, as this may cause coughing or sneezing. If irritation of the eyes or airways occurs, or if any side effects become severe, notify your doctor immediately.

The treated area may be sensitive to heat for a few days following treatment. You may experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain—a cool compress or pain medicine can be provided to lessen your discomfort. Cenza can cause serious side effects, including pain and increased blood pressure during or right after treatment.

Your healthcare provider should check your blood pressure during treatment. If you have high blood pressure that is not well controlled by medicine, or have had recent heart problems, a stroke, or other vascular problems, you may be at increased risk and should discuss with your doctor whether Cenza is right for you.

Tell your doctor if you have reduced sensation in the feet. You may notice less feeling for heat or sharp pain where Cenza was applied, but this is usually minor and temporary. The most common side effects of Cenza are redness, pain, or itching where it was applied. Let your doctor know if any side effects bother you or do not go away.

To report suspected adverse reactions, contact Averitas Pharma Incorporated at 1-877-964-4798 (Option 1) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. For more information, ask your healthcare provider or pharmacist. Please see full prescribing information.