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 www.fda.gov/medwatch 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.