Qutenza

Qutenza (capsaicin) 8% topical system is a prescription skin patch used in adults to treat nerve pain after shingles (postherpetic neuralgia [PHN]) and nerve pain of the feet caused by diabetes (diabetic peripheral neuropathy [DPN]). A healthcare professional applies up to four Qutenza topical systems to the painful area in the clinic, for 60 minutes for PHN or 30 minutes on the feet for DPN. A single treatment can be repeated every 3 months if needed.

Qutenza contains a synthetic version of capsaicin, the compound that gives chili peppers their heat. At 8%, it is a much higher strength than the capsaicin creams, lotions, and patches available over the counter, which is why it must only be applied and removed by a healthcare professional.

Qutenza was first approved by the FDA on November 16, 2009, for PHN, and was approved for DPN of the feet on July 17, 2020. There is no generic 8% capsaicin topical system.

Capsaicin activates TRPV1 receptors on pain-sensing nerve fibers in the skin. This first causes burning or stinging during application. Pain relief that follows is thought to be due to a reduction in these pain-sensing nerve endings in the treated skin. Over several months, the nerve fibers may gradually grow back and pain may return, which is why treatment can be repeated every 3 months.

Very little capsaicin reaches the bloodstream. In PHN studies, low levels (less than 5 ng/mL) were found in about one-third of patients, and these were gone 3 to 6 hours after the patch was removed.

Qutenza was studied in three 12-week, double-blind, randomized, controlled trials. All patients received a single application, with a topical anesthetic applied beforehand.

In the PHN studies, the control patch contained a very low dose of capsaicin (0.04%) to mimic the burning sensation. In the DPN study, the control was a placebo patch with no capsaicin. Some PHN patients had less pain as early as week 1, which lasted throughout the 12-week study.

Qutenza must only be applied and removed by a healthcare professional. It is never given to patients to use at home.

Touching Qutenza, or items that have been in contact with it, and then touching other parts of your body can cause severe irritation of the eyes, mucous membranes, airways, and skin. Do not touch Qutenza or the treatment area during application. Qutenza is not applied to the face, eyes, mouth, nose, or scalp.

Breathing in capsaicin can cause coughing or sneezing. Tell your healthcare provider right away if your eyes or airways become irritated or if any side effect becomes severe.

There are no conditions in which Qutenza must never be used (no contraindications). Before treatment, tell your healthcare provider if you:

• Have high blood pressure, especially if it is not well controlled
• Have had a recent heart attack, stroke, or other heart or blood vessel problem
• Have reduced feeling in the area to be treated, such as your feet
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

If you have DPN, your feet will be examined before each treatment to check for skin damage related to neuropathy or poor circulation. Qutenza is only used on dry, unbroken skin.

Qutenza is approved for adults only. Its safety and effectiveness have not been studied in people younger than 18 years. No dose adjustment is needed for older adults.

Pregnancy and breastfeeding

Very little capsaicin is absorbed into the body after Qutenza treatment, so it is not expected to reach an unborn baby or pass to a breastfed infant. If you are breastfeeding, Qutenza should not be applied directly to the nipple or areola.

Qutenza is applied in a well-ventilated clinic room by a healthcare professional wearing nitrile (not latex) gloves. A face mask and protective glasses are also advisable for staff. A typical treatment involves these steps:

• The painful area is marked on the skin. Hair may be clipped (not shaved), and the area is washed and dried.
• A numbing (topical anesthetic) medicine may be applied first and then wiped off.
• Qutenza can be cut to fit the size and shape of the painful area. On the feet, it can be wrapped around the top, sides, and sole. A dressing such as rolled gauze may be used to keep it in place.
• Qutenza is left on for 60 minutes for PHN or 30 minutes for DPN of the feet, and is then gently and slowly rolled off to avoid releasing capsaicin into the air.
• Cleansing Gel is applied to the area for at least 1 minute, wiped off, and the skin is washed with mild soap and water.

Each Qutenza topical system measures 14 cm x 20 cm (280 cm2).

Pain and burning during treatment

Even with a numbing medicine applied first, you may have substantial pain and burning while Qutenza is on and after it is removed. Your healthcare provider can use cooling or pain medicine to help. Too much cooling can cause frostbite, so cooling packs should come from the refrigerator (not the freezer) and should not be placed directly on the skin.

Increase in blood pressure

Blood pressure may rise briefly during or soon after treatment, usually by less than 10 mm Hg, and may stay raised for about 2 hours after removal. These increases are linked to treatment-related pain. Your blood pressure will be checked during treatment. People with unstable or poorly controlled high blood pressure, or a recent heart attack, stroke, or other cardiovascular event, may be at higher risk.

Reduced sensation

You may have less feeling for heat or sharp pain in the treated area. This is usually minor and temporary. If you already have reduced sensation, your healthcare provider will check it before each treatment and may stop Qutenza if it gets worse.

Severe burns

Second-degree and third-degree burns have been reported after Qutenza treatment. Some third-degree burns needed hospital care and skin grafts, when Qutenza was used for an unapproved condition, applied more often than recommended, or applied to skin that had previous injury. Get medical help if you have severe, continuing pain or blisters or other skin damage after treatment.

The most common side effects of Qutenza are redness, pain, and itching where the topical system was applied. Most were temporary, and pain scores usually returned to normal by the end of the treatment day. Only 1% of patients stopped treatment early because of side effects.

Since approval, second-degree and third-degree burns with scarring, and accidental exposure causing eye pain, cough, and eye or throat irritation, have also been reported.

Treated skin may be sensitive to heat, such as hot showers or baths, direct sunlight, or vigorous exercise, for a few days after treatment.

This is not a complete list of side effects. Call your doctor for medical advice about side effects. You may report side effects to Averitas Pharma at 1-877-900-6479 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• PHN: a single 60-minute application of up to four topical systems.
• DPN of the feet: a single 30-minute application of up to four topical systems on the feet.

Treatment may be repeated every 3 months or as warranted by the return of pain, but not more often than every 3 months.

• Do not touch Qutenza, the treatment area, or items that have touched Qutenza during treatment.
• Do not touch your eyes or other areas not being treated.
• Do not sniff or breathe in close to Qutenza, as inhaling capsaicin can cause coughing or sneezing.
• For a few days after treatment, avoid heat on the treated area, such as hot showers or baths, direct sunlight, and vigorous exercise.

There is no experience of Qutenza overdose in humans and no specific antidote. If an overdose is suspected, Qutenza is removed gently, Cleansing Gel is applied for 1 minute and wiped off, and the area is washed with soap and water.

No drug interaction studies have been done with Qutenza. Laboratory studies show capsaicin does not affect liver cytochrome P450 enzymes at levels far higher than those found in the blood after treatment, so interactions with other medicines are unlikely.

Qutenza is stored and handled in the clinic. The carton is kept at 68°F to 77°F (20°C to 25°C), with brief storage between 59°F and 86°F (15°C and 30°C) allowed. Each topical system stays in its sealed pouch until immediately before use. Used and unused Qutenza, cut pieces, Cleansing Gel, gloves, and packaging are disposed of as biomedical waste.

Active ingredient: capsaicin 8% (640 mcg per cm2), 179 mg per topical system.

Inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive, and white ink.

Cleansing Gel ingredients: butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.

Qutenza is supplied in cartons of one topical system with one 50 g tube of Cleansing Gel, two topical systems with one tube of Cleansing Gel, or four topical systems with three tubes of Cleansing Gel.

Qutenza is manufactured for Averitas Pharma, Inc. (a Grünenthal company), Morristown, NJ 07960, USA, by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany. For questions about Qutenza, call 1-877-900-6479.