Qutenza
Pronunciation: kew-ten-za
Generic name: capsaicin topical
Dosage form: topical system (patches, 8%)
Drug class: Miscellaneous topical agents
What is Qutenza?
Qutenza (capsaicin 8% patch) is used to treat postherpetic neuralgia (PHN) or nerve pain of the feet caused by diabetic peripheral neuropathy (DPN). It is a prescription medication applied directly to the affected area by a healthcare professional for 30 to 60 minutes every 3 months.
Qutenza gained FDA approval on November 16, 2009. There is no generic available.
- Lower strength capsaicin patches, topical creams, and lotions can be brought from a drugstore without a prescription.
- Qutenza is approximately 80 times stronger than typical OTC products.
Mechanism of action
Qutenza contains capsaicin, which is the substance that gives heat to chili peppers. Capsaicin works by selectively targeting TRPV1 receptors (pain receptors) in the skin. When applied it:
- Initially causes a burning or tingling sensation
- Gradually desensitizes the pain receptors
- Reduces the transmission of pain signals to the brain
- Provides prolonged pain relief even after the patch is removed.
See Does Qutenza contain red chili peppers? for more information.
FDA-Approved Indications
Qutenza is indicated for the treatment of:
- Postherpetic neuralgia (PHN): Persistent pain following a shingles infection
- Diabetic peripheral neuropathy (DPN): Pain in the extremities (typically feet or legs) caused by nerve damage from diabetes.
Qutenza side effects
Common Side Effects
The most common side effects of Qutenza are skin reactions where the patch was applied, such as:
- A burning sensation
- Pain
- Redness
- Itching
- Swelling
- Skin bumps and lumps (papules)
- Dryness.
A mild burning sensation may last several hours or days, especially after the first time Qutenza is applied.
Less Common Side Effects
- Temporary increases in blood pressure during and immediately after treatment
- Nausea
- Headache
- Cough
- Sneezing (due to breathing in airborne capsaicin).
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Precautions and Warnings
Qutenza patches must only be applied by a healthcare professional. Never apply or remove Qutenza yourself.
Do not touch Qutenza or items exposed to capsaicin. Touching Qutenza and then accidentally touching other areas of your body can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin.
- This includes your eyes or other unintended target areas during the Qutenza application.
- Qutenza is not for use near eyes or mucous membranes.
- Do not sniff or inhale near Qutenza as this may cause you to cough or sneeze. Stop using Qutenza and call your doctor at once if you have trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).
- If irritation of eyes or airways occurs or any side effects become severe, notify your doctor immediately.
You may 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.
- You may get frostbite if you cool your skin too much.
- You can use a cooling pack from the refrigerator (not the freezer) and avoid putting it directly on skin.
- Seek medical attention if you experience strong and continuous pain or skin lesions such as blisters after treatment.
Qutenza can cause serious side effects, including pain, severe burns, 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 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.
Tell your doctor if you have reduced sensation in the feet. You may notice that you have less feeling for hot or sharp pain where Qutenza was applied, but this is usually minor and temporary.
Treated areas may be sensitive to heat (such as hot water, direct sunlight, vigorous exercise) for a few days after treatment.
Hypersensitivity reactions. Qutenza may cause an allergic reaction in some people. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before receiving this medicine
- Do not receive Qutenza if you are allergic to chili peppers, capsaicin, Qutenza, or any other ingredients in the formulation.
- Should not be used on broken or irritated skin.
- Not recommended to be applied to the face, scalp, or mucous membranes (for example, inside the nose or on the lips).
Before Qutenza is applied to your skin, tell your healthcare provider about all your medical conditions, including if you:
- have any allergies
- have high blood pressure or take medications for blood pressure
- have any skin conditions, such as eczema or psoriasis
- are pregnant or intend to become pregnant. It is not known whether Qutenza will harm an unborn baby
- are breastfeeding or intend to breastfeed. It is not known whether capsaicin passes into breast milk or if it could harm a nursing baby. Do not apply Qutenza to your breast area if you are breast-feeding a baby.
Qutenza is only approved for use in adults.
How is Qutenza applied?
Qutenza patches must only be applied by a healthcare professional. It should not be applied to open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.
- Remove jewelry or metal objects from the treatment area.
- Your skin should be clean and dry before the patches are applied.
- Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.
- This medicine is for use only on the skin.
Your healthcare provider will pre-treat the area with a topical anesthetic to reduce discomfort associated with the application of Qutenza.
- To keep the medication from getting on their hands, they will wear nitrile gloves. They will prepare the patches and press them on the skin.
- Once the patch has been applied, they will leave it in place for 60 minutes for postherpetic neuralgia, and 30 minutes for diabetic peripheral neuropathy of the feet.
- The treated skin should not be covered with a bandage or heating pad, because this can increase the burning sensation. It may be covered with clothing.
Post-Treatment Care
- The treated area may remain sensitive for a few days.
- Cooling measures (ice packs) may help alleviate discomfort.
- Avoid hot showers or baths immediately after treatment.
- Avoid vigorous exercise that might irritate the treated area.
- Keep the area clean and avoid applying other topical products unless directed.
Dosing information
Usual Adult Qutenza Dose for Postherpetic Neuralgia:
Up to 4 patches in a single, 60-minute application.
- Treatment may be repeated every three months or as warranted by the return of pain (but not more frequently than every 3 months).
Usual Adult Qutenza Dose for Diabetic Peripheral Neuropathy (DPN) of the Feet:
Up to 4 patches in a single, 30-minute application.
- Treatment may be repeated every three months or as warranted by the return of pain (but not more frequently than every 3 months).
What should I avoid while using Qutenza?
Avoid inhaling the odor or dried residue of Qutenza during treatment. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.
Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off the treatment area.
Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub.
Do not use other medicated skin products, including muscle pain creams or lotions, on areas where Qutenza has been applied, unless your doctor has told you to.
Efficacy and Clinical Response
- Pain relief may begin within days after treatment.
- Clinical trials report the full effect typically develops over 1-2 weeks.
- Relief can last for up to 3 months, at which point treatment can be repeated.
- Not all patients respond equally; individual results may vary.
Insurance Coverage and Availability
- Requires a prescription from a healthcare provider.
- Coverage varies by insurance plan; prior authorization may be required.
- Available only as patches containing 8% capsaicin (179 mg).
Drug interactions
Qutenza is not known to have significant interactions with other medications as it acts locally with minimal systemic absorption.
Ingredients
Active: capsaicin 179 mg.
Inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive, and white ink.
Each Qutenza patch contains 8% capsaicin (640 mcg per cm2), for a total of 179 mg of capsaicin.
Who makes Qutenza?
Qutenza (capsaicin 8% patch) is manufactured by Averitas Pharma, Inc., a subsidiary of Grünenthal GmbH, headquartered in Aachen, Germany. Averitas Pharma, the U.S. subsidiary handling Qutenza, operates from its U.S. headquarters in Morristown, New Jersey. Other notable products by Grünenthal are:
- Tramadol (Ultram, Zydol) - for moderate to moderately severe pain
- Buprenorphine patches (Transtec) - for moderate to severe chronic pain
- Versatis (lidocaine medicated plaster) - a topical anesthetic for post-herpetic neuralgia
- Palexia SR (extended-release tapentadol) - a long-acting formulation for chronic pain management.
Popular FAQ
Does Qutenza contain red chili peppers?
Yes, Qutenza is a prescription skin patch that contains capsaicin, the active ingredient that gives the heat to a chili pepper. It contains 8% capsaicin (179 mg) per patch. Continue reading
References
More about Qutenza (capsaicin topical)
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- During pregnancy
- FDA approval history
- Drug class: miscellaneous topical agents
- Breastfeeding
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