The QUTENZA® Treatment Process

Summary of "QUTENZA® Application Video Patients"

• Overview of QUTENZA (00:09): QUTENZA is a treatment designed for diabetic nerve pain, providing up to 3 months of relief with a single 30-minute application by a healthcare provider, and can be administered up to four times a year.

• Preparation and Application (00:43): Before treatment, feet are washed and examined for any injuries. A numbing agent may be applied, and the QUTENZA patches are cut to fit the painful areas, secured with gauze or a bandage.

• Treatment Sensation and Post-Application (01:15): During the 30-minute application, a warming or burning sensation may be felt. After removal, a cleansing gel is applied, and care instructions include washing feet and wearing clean socks afterward.

• Safety Information and Side Effects (02:18): Treatment must be performed by a healthcare provider. Risks include severe irritation if the patches come into contact with skin or eyes, and sensitivity to heat may occur post-treatment. Common side effects are redness, pain, or itching at the application site.

• Monitoring and Follow-Up (03:57): Blood pressure will be monitored during treatment. Patients should report severe side effects and schedule follow-up appointments for ongoing relief. For adverse reactions, contact information for reporting is provided.

Did You Know

QUTENZA offers relief from diabetic nerve pain for up to 3 months with just one 30-minute treatment, and it can be applied up to four times a year, providing a convenient management option for chronic pain.

Transcript:

Many people with diabetes suffer from diabetic nerve pain in the 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 ensure 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 remove any residue, a special Cenza topical cleansing gel will be applied and left on for 1 minute. Once the gel has been completely removed, your feet will be gently washed and dried. When your feet are dry, you're ready to put your socks and shoes back on and make your next appointments.

Wash your feet again and put on clean socks once you are home. Your feet may be sensitive to heat for one or two days following your application. Avoid hot showers or 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 of the feet and can be applied up to four times a year. Be sure to schedule your next appointment before you leave to help ensure ongoing relief.

Important Safety Information

Indication: Cenza (Capsaicin 8% Topical System) is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) of the feet.

Important Safety Information:

• Treatment with Cenza must be performed only by a healthcare provider.
• You should never apply or remove Cenza yourself.
• Do not touch Cenza or items exposed to capsaicin. Touching Cenza 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 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 you to cough or sneeze.
• 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 (e.g., hot showers, baths, direct sunlight, or vigorous exercise) 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 medicine for pain can be provided to help lessen your discomfort.
• Cenza 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.
• 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 Cenza 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 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.
• You should tell your doctor if any side effects bother you or do not go away.

To report suspected adverse reactions, contact Averitas Pharma Incorporated at 1-877-900-6479 (Option 1) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, ask your healthcare provider or pharmacist. Please see full prescribing information.