IMPORTANT SAFETY INFORMATION:
Only physicians or healthcare professionals under the close supervision of a physician are to administer QUTENZA.
Warnings and Precautions:
- Do not apply QUTENZA to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.
- Aerosolization of capsaicin can occur and inhalation may result in coughing or sneezing.
- If skin not intended to be treated comes into contact with QUTENZA, clean area using Cleansing Gel.
- Patients may experience substantial procedural pain. Prepare to treat pain with local cooling (such as a cold pack) and/or appropriate analgesic medication.
- Transient increases in blood pressure may occur during and shortly after the QUTENZA treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension or a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment.
- If opioids are used to treat pain associated with the application procedure, please note that opioid treatment may affect the patient's ability to perform potentially hazardous activities such as driving or operating heavy machinery.
In clinical trials, serious adverse reactions included application associated pain and increase in blood pressure. The most common adverse reactions (≥ 5% and greater than control) were application-site erythema, application-site pain, application-site pruritus, or application-site papules, and nausea.
To report an adverse event, you can visit www.fda.gov/medwatch or call at 1-800-FDA-1088; or you can call Averitas Pharma, Inc. at 1-877-900-6479.
QUTENZA® (capsaicin) 8% Patch is indicated for the management of neuropathic pain associated with postherpetic neuralgia.
Please see full Prescribing Information.
Carton with one patch + cleansing gel: NDC #72512-928-01
Carton with two patches + cleansing gel: NDC #72512-929-01