Brand name: Qutenza
Drug class: Antipruritics and Local Anesthetics

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Transient receptor potential vanilloid 1 (TRPV1) receptor agonist.

Uses for Capsaicin (Topical)

Postherpetic Neuralgia

Capsaicin 8% topical system (i.e., patch) is used for treatment of neuropathic pain associated with postherpetic neuralgia (PHN).

First-line treatments for neuropathic pain include gabapentinoids (gabapentin and pregabalin), tricyclic antidepressants (TCAs), and serotonin-norepinephrine reuptake inhibitors (SNRIs; duloxetine and venlafaxine). Capsaicin patches are recommended as a first-line treatment option in some guidelines, but second-line or later in other guidelines.

Diabetic Peripheral Neuropathy

Capsaicin 8% patch is used for treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

First-line treatments for neuropathic pain include gabapentinoids (gabapentin and pregabalin), sodium channel blockers (e.g., carbamazepine, oxcarbazepine, lamotrigine), tricyclic antidepressants (TCAs), and serotonin-norepinephrine reuptake inhibitors (SNRIs; duloxetine and venlafaxine). Capsaicin patches are recommended as a first-line treatment option in some guidelines and as a second-line or later option in other guidelines.

HIV-associated Distal Sensory Polyneuropathy

Capsaicin 8% patch has been used for the treatment of painful HIV-associated distal sensory polyneuropathy^{† [off-label]}; however, very low quality evidence exists to support use.

Capsaicin (Topical) Dosage and Administration

General

Pretreatment Screening

• In patients with DPN, carefully exam the feet prior to each application of capsaicin patch to detect skin lesions related to underlying neuropathy or vascular insufficiency.

• Assess patients with pre-existing sensory deficits for signs of sensory deterioration or loss prior to each application of capsaicin patch.

• If the patient has unstable or poorly controlled hypertension or a recent history of cardiovascular or cerebrovascular events, consider these factors prior to initiating capsaicin treatment.

Patient Monitoring

• Monitor BP during and following the treatment procedure.

Premedication and Prophylaxis

• Pretreatment with a topical anesthetic (e.g., lidocaine 4% cream) is recommended to reduce discomfort associated with application of the capsaicin patch. Apply the topical anesthetic to the entire treatment area and surrounding 1-2 cm. Keep the local anesthetic in place until the skin is anesthetized, then remove the topical anesthetic with a dry wipe. Gently wash the treatment area with mild soap and water, and dry thoroughly before applying the capsaicin patch.

Dispensing and Administration Precautions

Handling and Disposal

• Patients should not self-administer or handle capsaicin patches. Only physicians or healthcare professionals should administer and handle the drug.

• Unintended exposure to capsaicin can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others.

• Adminster capsaicin in a well-ventilated treatment area. Wear only nitrile gloves when handling the patches or any item that comes into contact with the patches, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection. Use of a face mask and protective glasses is advised for healthcare professionals.

• Keep the patches in the sealed pouch until immediately before use.

• During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. Accidental exposure to the eyes and mucous membranes can occur from touching capsaicin patches or items exposed to the patches and then touching the eyes and mucous membranes. If irritation of eyes or mucous membranes occurs, flush eyes and mucous membranes with cool water. Remove the affected individual (healthcare professional or patient) from the vicinity of the patch.

• Aerosolization of capsaicin can occur upon rapid removal of the capsaicin patch. Therefore, remove the patch gently and slowly by rolling the adhesive side inward.

• Immediately after use, clean all areas that had contact with capsaicin and properly dispose of the patch (including any unused cut pieces) and other potentially contaminated treatment supplies (i.e., packaging, cleansing gel, gloves) in accordance with local biomedical waste procedures.

Administration

Apply 8% topical system to affected areas of the skin. Administer by a healthcare professional in a controlled setting to avoid severe irritation from unintended exposure (see Handling and Disposal under Dosage and Administration).

Use nitrile gloves when handling the patches; do not use latex gloves. Use of a face mask and protective glasses also advised.

Store patches in sealed pouch until immediately before use. Inspect the pouch prior to use; do not use if damaged or torn.

Apply the patches to dry, intact (unbroken) skin; do not apply to the face, eyes, mouth, nose, or scalp. A physician or healthcare professional should identify and mark the treatment area (pain areas of hypersensitivity and allodynia).

In patients with DPN, the patch may be wrapped around the dorsal, lateral, and plantar surfaces of each foot to completely cover the treatment area.

If necessary, hair around the treatment area can be clipped to promote patch adhesion; do not shave the hair.

The patches may be cut to match the size and shape of the treatment area. Cut patch before removing protective release liner, and dispose of any unused pieces properly. Up to 4 patches may be used to cover a treatment area.

Once patch is applied, leave on for 60 minutes (for PHN) or 30 minutes (for DPN). A dressing such as rolled gauze may be used to cover the patch to ensure that it maintains contact with the treatment area.

Use nitrile gloves to remove patch by gently and slowly rolling inward. After removal, apply the manufacturer-supplied cleansing gel to treatment area and leave on for at least 1 minute. Remove gel with a dry wipe and gently wash the area with mild soap and water. Dry thoroughly.

Treatment area may be sensitive for a few days to heat (e.g., hot showers/baths, direct sunlight, vigorous exercise).

Dosage

Adults

PHN

Topical

A single 60-minute application of up to 4 topical systems to affected area. May repeat treatment every 3 months or as necessary if pain returns (but no more frequently than once every 3 months).

DPN

Topical

A single 30-minute application of up to 4 topical systems to the feet. May repeat treatment every 3 months or as necessary if pain returns (but no more frequently than once every 3 months).

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No dosage adjustments required.

Cautions for Capsaicin (Topical)

Contraindications

• None.

Warnings/Precautions

Severe Irritation with Unintended Capsaicin Exposure

Unintended exposure to the patch can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Follow recommended procedures for handling and disposal. (See Dosage and Administration.)

If skin not intended to be treated is exposed, apply the manufacturer-supplied cleansing gel for 1 minute and wipe off with dry gauze. Wash area with soap and water. Flush eyes or mucous membranes with cool water if affected.

Inhalation of airborne capsaicin can result in coughing or sneezing. Administer patches in a well-ventilated treatment area. Provide supportive medical care if shortness of breath develops. If irritation of airways occurs, remove affected individual (healthcare professional or patient) from the vicinity of the patches. If respiratory irritation worsens or does not resolve, do not re-expose affected individual.

Application Site Pain

Patients may experience substantial procedural pain and burning during application and for a few days following removal of patch, even with use of a local anesthetic prior to administration.

May treat acute pain during and following application procedure with local cooling (e.g., ice pack) and/or appropriate analgesic medication.

Increased Blood Pressure

Transient increase in BP reported. Average increase was <10 mm Hg, although some patients had greater increases, which lasted for approximately 2 hours after patch removal.

Observed increase in BP unrelated to pretreatment BP, but related to treatment-related increases in 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 treatment.

Reduced Sensory Function

Reductions in sensory function reported following administration. Generally minor and temporary (including to thermal and other harmful stimuli).

Clinically assess all patients with pre-existing sensory deficits for signs of sensory deterioration or loss prior to each application. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, reconsider continued use of capsaicin treatment.

Specific Populations

Pregnancy

Maternal use of capsaicin 8% patches not expected to result in fetal exposure; systemic absorption following topical administration is negligible. No evidence of malformations observed in animal reproductive studies.

Lactation

Breastfeeding not expected to result in fetal exposure; systemic absorption following topical administration is negligible. No data on the effects of capsaicin on human milk production.

To minimize potential direct exposure of capsaicin to the breastfed infant, avoid applying patches directly to the nipple and areola.

Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for capsaicin and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Females and Males of Reproductive Potential

Reduction in number and percent of motile sperm observed in male rats administered capsaicin 8% patch; however, reductions did not adversely affect fertility. Clinical significance not known.

Pediatric Use

Safety and effectiveness in pediatric patients <18 years of age not established.

Geriatric Use

Safety and effectiveness similar in geriatric patients and younger patients.

Common Adverse Effects

Most common adverse reactions (≥5%): application site erythema, application site pain, application site pruritus.

Drug Interactions

No clinical drug interaction studies performed. Does not inhibit or induce CYP enzymes; therefore, drug interactions unlikely.

Capsaicin (Topical) Pharmacokinetics

Absorption

Bioavailability

Systemic absorption following topical administration negligible.

Following 60-minute application in patients with PHN, transient, low (<5 ng/mL) systemic exposure to capsaicin observed in about one-third of patients.

Highest plasma concentration detected was 4.6 ng/mL and occurred immediately after patch removal. Most quantifiable levels were observed at the time of patch removal and were below the limit of quantitation 3 to 6 hours later.

Elimination

Metabolism

No detectable levels of metabolites observed.

Stability

Storage

Topical

Topical System

Store at 20–25°C (excursions permitted between 15–30°C). Keep in sealed pouch until immediately before use.

Actions

• Alkaloid found in hot peppers and related plants; a transient receptor potential vanilloid 1 (TRPV1) receptor agonist.

• TRPV1 receptors are upregulated during chronic pain states, reducing the stimulation threshold and increasing pain perception.

• Following topical application, capsaicin causes enhanced sensitivity followed by a period of reduced sensitivity; after repeated applications, persistent desensitization occurs.

Advice to Patients

• Inform patients that accidental exposure from touching capsaicin or items exposed to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin.

• Instruct patients not to touch their eyes and other unintended target areas and that if irritation of eyes or airways occurs, or if any of the side effects become severe, to notify their doctor immediately.

• Inform patients that the treated area may be sensitive to heat (e.g., hot showers/bath, direct sunlight, vigorous exercise) for a few days following treatment.

• Inform patients that they may be given medication to treat acute pain during and after the capsaicin application procedure.

• Inform patients that as a result of treatment-related increases in pain, small transient increases in blood pressure may occur during and shortly after capsaicin treatment and that blood pressure will be monitored during the treatment procedure. Instruct patients to inform the physician if they have experienced any recent cardiovascular events.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

• Does Qutenza contain red chili peppers?

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