Ordering & Access
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.
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.
QUTENZA is manufactured for Averitas Pharma, Inc., by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany.
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
QUTENZA can be used alone or in combination with other oral medications for pain.1
There are no specific contraindications associated with the use of QUTENZA in people with a history of the conditions stated above. However, a patient’s history of past and current skin conditions should be evaluated and considered before treating with QUTENZA.1
QUTENZA should be used only on dry, intact (unbroken) skin. In patients treated for painful diabetic peripheral neuropathy, a careful examination of the feet should be undertaken prior to each application of QUTENZA to detect skin lesions related to underlying neuropathy or vascular insufficiency.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.
Reductions in sensory function have been reported following
administration of QUTENZA. Decreases in sensory function are
generally minor and temporary. All patients with
pre-existingsensory 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 or pre-existingsensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.
From the STEP Study: The median time to treatment response with capsaicin 8% in this study was 19 days, compared with 72 days with placebo. With regard to pain response throughout the study, a greater numerical percentage reduction from baseline in average daily pain score each week became apparent from Week 2 in the capsaicin 8% group compared with the placebo group.2
Following the application of QUTENZA, the patient may experience some discomfort (potentially on the bottom of the feet). It is advised to discuss the possibility of arranging a ride home following the procedure. This decision should be made prior to the application appointment. Patients are considered safe to drive following the application of QUTENZA.
The treated area may be sensitive for a few days to heat (eg, hot showers/baths, direct sunlight, vigorous exercise). Transient increases in blood pressure may occur in patients during and shortly after QUTENZA treatment. Monitor blood pressure during and following the treatment procedure. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss is due to QUTENZA, treatment should be discontinued.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, 30-minute procedure 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 for 60 minutes prior to the application of QUTENZA.1
- Before QUTENZA application, a physician or healthcare professional must identify and mark the painful area, including areas of hypersensitivity and allodynia.
- Pre-treat the identified area and surrounding 1 to 2 cm with a topical anesthetic to reduce discomfort. Remove anesthetic with a dry wipe; wash area with soap and water, drying skin thoroughly before applying QUTENZA.
- Apply QUTENZA to the previously identified areas by placing QUTENZA on skin, while slowly removing release liner from underneath.
- Remove QUTENZA by gently and slowly rolling the adhesive side inward.
- After removal of QUTENZA, apply the supplied Cleansing Gel for one minute, and then remove it with a dry wipe; wash area with soap and water.