Qutenza (Transdermal patch) Instructions for Use

Marketing Authorization Holder

Astellas Pharma Europe B.V. (Netherlands)

Manufactured By

LTS Lohmann Therapie-Systeme, AG (Germany)

Manufactured By

CONTRACT PHARMACEUTICALS, Ltd. (Canada)

Quality Control Release

GP GRENZACH PRODUKTIONS, GmbH (Germany)

ATC Code

N01BX04 (Capsaicin)

Active Substance

Capsaicin (USP United States Pharmacopeia)

Dosage Form

Qutenza

Plaster 179 mg/280 cm2: sachet bag in set with cleansing gel 50 g (tube)

Dosage Form, Packaging, and Composition

Plaster transparent on transparent removable protective layer, protective layer covers plaster from long and short sides; gel from transparent to opalescent, colorless, semisolid, without mechanical inclusions.

Auxiliary substances : silicone adhesive BIO-PSA-4201 – 1098 mg on 280 cm² (49% by mass), silicone adhesive BIO-PSA-4301 – 470 mg on 280 cm² (21% by mass), monoethyl ether of diethylene glycol (MEEG) – 430 mg on 280 cm² (19.2% by mass), silicone oil 12500 cSt – 45 mg on 280 cm² (2% by mass), ethylcellulose N50 – 18 mg on 280 cm² (0.8% by mass).

Composition of cover film polyethylene terephthalate with siliconized inner side.
Composition of protective film polyester film, coated with fluoropolymer.

Composition of cleansing gel macrogol 300 – 44.5 g on 50 g (89.1% by mass), carbomer – 0.5 g on 50 g (1.0% by mass), purified water – 4.9 g on 50 g (9.8% by mass), sodium hydroxide pellets (E524) – 0.02 g on 50 g (0.03% by mass), disodium edetate – 0.05 g on 50 g (0.1% by mass), butylhydroxyanisole (E320) – 0.01 g on 50 g (0.02% by mass).

1 pc. – sachet bag (1) in set with cleansing gel (tube 50 g) – cardboard packs.

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Anesthetics, other local anesthetics

Indications

• For the management of neuropathic pain in adults, either as a sole agent or as part of a combination analgesic regimen.
• Treatment of postherpetic neuralgia (PHN), which is nerve pain following an outbreak of shingles (herpes zoster).
• Management of painful diabetic peripheral neuropathy (DPN) affecting the feet, providing localized relief for this specific neuropathic pain condition.

Qutenza is indicated specifically for topical use on intact skin and is not intended for the treatment of musculoskeletal pain, headaches, or visceral pain. The plaster delivers a high concentration of capsaicin directly to the area of pain, leading to a reduction in pain signals from the treated skin.

Contraindications

• Hypersensitivity to the active substance (capsaicin) or to any of the excipients listed in the composition, such as the silicone adhesives or monoethyl ether of diethylene glycol, as this may lead to severe allergic reactions.
• Application of the plaster on broken or irritated skin, including open wounds, rashes, or sunburns, due to the risk of significantly increased systemic absorption and severe local skin reactions.
• Patients with a history of severe cardiovascular or cerebrovascular events (e.g., unstable angina, recent myocardial infarction, or stroke) should not use Qutenza unless the potential benefits outweigh the risks, as the procedure may be associated with transient increases in blood pressure.
• Concomitant use at the same application site with other topical medicinal products, as the effects of such combinations have not been studied and may lead to unpredictable interactions or altered absorption.

The use of Qutenza is strictly contraindicated in children and adolescents under the age of 18 years due to a lack of safety and efficacy data in this population. Healthcare professionals must perform a thorough patient assessment prior to each application to ensure there are no contraindications.

Dosage Regimen

The treatment with Qutenza must be administered by a healthcare professional trained in the application and removal procedure. Self-administration by the patient or a caregiver is not recommended. The recommended dose is a single application for 60 minutes to the most painful area(s).

The treatment area should be determined based on the location of the patient’s neuropathic pain and should not exceed 1000 cm² (e.g., up to four plasters) per session. If a larger area requires treatment, sequential applications may be considered with appropriate intervals. Prior to application, the skin must be dry and intact. If necessary, the hair at the application site should be clipped, not shaved, to minimize skin irritation.

After the 60-minute application period, the plaster(s) must be removed and the treatment area must be thoroughly cleansed with the provided cleansing gel to remove any residual capsaicin. The cleansing gel should be applied generously and then wiped off. The application site should not be touched with bare hands by the patient or the healthcare professional; non-sterile gloves must be worn throughout the entire procedure.

A minimum treatment interval of 90 days is recommended. However, the need for re-treatment should be re-evaluated at each visit based on the patient’s response and the return of pain. Some patients may experience adequate pain relief for a longer period. Pre-treatment with topical anesthetics or oral analgesics may be considered to mitigate the initial application-related discomfort, which is common.

Adverse Reactions

The most frequently reported adverse reactions are local application-site reactions. These are very common (≥1/10) and include erythema (redness), pain, pruritus (itching), papules, edema, and dryness. These reactions are typically transient and resolve spontaneously within a few hours to several days.

Systemic adverse reactions are less common but may occur. A transient, moderate increase in blood pressure may occur during and shortly after the application procedure, which is why blood pressure should be monitored before, during, and after treatment. Other uncommon (≥1/1,000 to <1/100) adverse reactions include nausea, vomiting, and hypersensitivity reactions such as skin rash or urticaria at the application site or elsewhere.

Serious adverse reactions are rare. Cases of severe, application-site pain requiring premature removal of the plaster have been reported. Accidental exposure to the eyes or mucous membranes can cause severe irritation and pain; if this occurs, the affected area should be flushed copiously with water and medical advice sought. Patients should be advised to avoid touching the application site and then touching their eyes or other sensitive areas, even after the plaster has been removed and the area cleansed, as residual capsaicin may remain on the skin for some time.

Drug Interactions

Formal drug interaction studies have not been conducted with Qutenza. However, due to its mechanism of action and local application, systemic drug interactions are considered unlikely. The primary concern involves interactions at the application site.

Concomitant use of other topical products (e.g., creams, ointments, oils, or lotions) on the same skin area intended for Qutenza application is not recommended. These products could alter the absorption of capsaicin or the adhesion of the plaster, potentially increasing the risk of adverse reactions or reducing efficacy. It is advised to discontinue such products for a sufficient period prior to Qutenza treatment.

Patients taking medications that affect pain perception or neurological function, such as opioids, anticonvulsants (e.g., gabapentin, pregabalin), or antidepressants (e.g., duloxetine, amitriptyline), should be monitored closely, as the overall analgesic effect may be altered. There is no evidence to suggest that Qutenza affects the plasma concentrations of these systemically administered drugs.

Caution is advised in patients taking antihypertensive medications, due to the potential for transient increases in blood pressure during the application procedure. Blood pressure monitoring is recommended for these patients. No specific pharmacokinetic interactions with orally administered drugs are anticipated.

Overdose

Overdose with Qutenza due to systemic absorption is unlikely given the localized nature of the treatment. The primary manifestation of overdose would be an exacerbation of local adverse reactions, such as severe pain, burning sensation, erythema, and blistering at the application site.

In case of a suspected overdose, such as prolonged application beyond 60 minutes or application to a much larger area than recommended, the plaster(s) should be removed immediately. The affected skin area must be thoroughly cleansed with the provided cleansing gel. Soap and water can be used if the cleansing gel is not available, but multiple washes may be necessary. Application of a cooling compress (such as an ice pack) to the skin may provide symptomatic relief from the burning sensation.

There is no specific antidote for capsaicin overdose. Treatment is supportive and should focus on symptomatic management of pain. In cases of severe pain, the use of topical coolants or appropriate oral analgesics may be considered. If systemic symptoms occur, which is highly improbable with topical application, standard supportive measures should be instituted. Medical attention should be sought if severe local reactions persist or if systemic symptoms develop.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.