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Adverse Event Reporting:

Physicians, other health care providers and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can:

  • In the U.S., 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.

Adverse Event Reporting:

Physicians, other health care providers and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can:

Warnings and Precautions:

  • Qutenza is not for use near eyes or mucous membranes. Do not sniff or inhale near the Qutenza patch as this may cause you to cough or sneeze.
  • Do not touch the Qutenza patch with your hands. If you touch the patch, it may cause burning and stinging; if this occurs, tell your healthcare provider.
  • 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 who 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.
  • If opioids are used to treat pain associated with the application procedure, these medicines may affect your ability to perform potentially hazardous activities such as driving or operating heavy machinery.

Side Effects:

  • In clinical studies, the most common drug-related side effects of Qutenza, which occurred in 5% or more of patients, included redness, pain, itching, or small bumps where Qutenza was applied, and nausea.
  • You should tell your doctor if any side effects bother you or do not go away.

These are not all the side effects of Qutenza. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For more information, ask your healthcare provider or pharmacist.

Please click here for full Prescribing Information.

Carton with one patch + cleansing gel: NDC number #10144-0928-01

Carton with two patches + cleansing gel: NDC number #10144-0929-01

Qutenza® is a registered trademark of Averitas Pharma, Inc.