The most frequently asked questions and answers about QUTENZA

FAQs
Ordering & Access
No, QUTENZA is only available through a Specialty Distributor or a Specialty Pharmacy. For a full list of our Specialty Distributors and Specialty Pharmacies, click here. Please call QUTENZA Customer Support at 877-900-6479 for more information.
QUTENZA is a prescription product that is prescribed and administered by a healthcare provider.
QUTENZA is sold by Averitas Pharma as a prescription drug in the United States. As such, we are unable to address your inquiry.
Patients can call QUTENZA Customer Support at 877-900-6479 for more information.
Requirements vary for different payers and plans. CoPilot provides dedicated resources to complete a full benefits investigation to evaluate all financial support options and gain approval for the procedure. QUTENZA Reimbursement Support Services can be reached at 855-802-8746, Monday through Friday, 9 AM to 7 PM ET, or visit MyQutenzaCoverage.com.
There are no coupons available at this time.
Product Information
QUTENZA is manufactured for Averitas Pharma, Inc., by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany.
QUTENZA is distributed through our Specialty Distributors. For a full list of these Specialty Distributors, click here.
At this time, we do not offer samples.
There are no other active ingredients in QUTENZA. The inactive ingredients in QUTENZA are diethylene glycol monoethyl ether (DGME, also called Transcutol), dimethicone, ethyl cellulose, polyester film, silicone adhesive and white ink. The Cleansing Gel, which is supplied with QUTENZA, has the following ingredients: butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.1
Approximately half of the patients in the pivotal trials were taking concomitant medications for their PHN-associated neuropathic pain. In both studies, regardless of whether patients were on concomitant medication or received QUTENZA alone, there was a greater reduction in Numeric Pain Rating Scale scores from baseline to Weeks 2-8 compared to the control group.1
In the PHN clinical trials, the most common adverse reactions were application site pain, erythema, pruritus, and site papules. QUTENZA is to be used only on dry, intact (unbroken) skin. While there are no contraindications for QUTENZA use in this patient population, the assessment of an individual patient's eligibility for treatment based on previous or current dermatological conditions or diseases needs to be made by the treating HCP.1
In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.1
Warnings and Precautions1
- Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin.
- Do not apply QUTENZA to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching QUTENZA or items exposed to capsaicin and then touching the eyes and mucous membranes. Wear nitrile gloves when administering QUTENZA and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of QUTENZA and flush eyes and mucous membranes with cool water.
- Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. Provide supportive medical care if shortness of breath develops.
- If skin not intended to be treated is exposed to QUTENZA, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.
- Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure 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.
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Reductions in sensory function have been reported following
administration of QUTENZA. Decreases in sensory function are
generally minor and temporary. All patients with
pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected orpre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.
While patient results may vary, in the clinical studies, some patients experienced a decrease in pain as early as 2 days which persisted throughout the study duration. For some patients, relief may take a few weeks.1
Patients should be able to drive themselves home as QUTENZA doesn't impair patients. However, depending on the area treated, on the shoulder, chest, or breast area, for example, patients may be sensitive to the safety belt. Make sure patients are aware of this if they are driving, and take measures to add additional padding between the belt and the treatment area.
It's quite common for the area to remain sensitive to heat for a few days after application. Patients may also continue to feel some burning or stinging sensation. These effects are commonly seen with QUTENZA patients and most of the application reactions will go away on their own and only last a short time.1
Application & Administration
QUTENZA should not be applied to the face, eyes, mouth, nose, or scalp so that risk of exposure to the eyes or mucous membranes is avoided.1
The recommended dose of QUTENZA is a single, 60-minute application of up to four topical systems. Treatment with QUTENZA may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).1
Even following use of a local anesthetic prior to administration of QUTENZA, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication. Based upon experience and feedback from users, local cooling packs may be sufficient; however, each patient is different.
Apply topical anesthetic to the entire treatment area and surrounding 1 to 2 cm, and keep the local anesthetic in place until the skin is anesthetized prior to the application of QUTENZA. In the clinical studies in PHN-associated neuropathic pain, this time frame was 60 minutes.1
Yes. Please refer to Section 2.3 Instructions for Use in the full Prescribing Information or the Application Video on QUTENZA.com.1