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About QUTENZA

QUTENZA Is the First and Only Treatment to Deliver
Prescription-Strength Capsaicin Directly to the Skin

Up to 3 months of pain relief

Up to 3 months of
pain relief

A 30-minute treatment for diabetic nerve pain of the feet

Acts locally

Acts locally

Treat diabetic nerve pain of the feet at the site of pain

No drug-drug interactions

No drug-drug interactions

QUTENZA can be used alone or in combination with other treatments

QUTENZA Works Differently to Treat Diabetic Nerve Pain of the Feet

  • Works to quiet damaged nerves
  • Can be used alone or in combination with other treatments

In Clinical Trials, QUTENZA Has Been Shown to Significantly Relieve Pain for up to 3 Months in People with Diabetic Nerve Pain of the Feet

  • Effective for patients who are already taking other pain medicines
  • Unlikely to interact with other medicines
  • May not work for everyone. Only you and your doctor can decide if QUTENZA is right for you

How Quickly Can QUTENZA Provide Relief?

In a clinical study, after one 30-minute application of QUTENZA, patients with diabetic nerve pain of the feet experienced pain relief after 19 days vs 72 days for patients who received a placebo. QUTENZA is applied by a healthcare professional, no more frequently than every 90 days.

19 Days

QUTENZA

72 Days

Placebo

Some patients did not respond to the first treatment of QUTENZA, but did respond to the second treatment of QUTENZA.

Most Common Side Effects

  • QUTENZA is a non-opioid, non-systemic treatment
  • QUTENZA has no known drug-drug interactions

QUTENZA can cause serious side effects, including severe irritation, pain, and increases in blood pressure during or right after treatment.

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.

Please see additional Important Safety Information.

See What Patients Think About QUTENZA

In a safety study, after one year of continued treatments with QUTENZA, 63% of patients preferred to continue with QUTENZA plus Standard of Care (SoC) vs 31% of patients who preferred SoC alone.

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.

  • Carton with one topical system + Cleansing Gel: NDC #72512-928-01
  • Carton with two topical systems + Cleansing Gel: NDC #72512-929-01
  • Carton with four topical systems + Cleansing Gel: NDC #72512-930-01