Drug Description
Each 280 cm2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm2 of patch (8 % w/w).ExcipientEach 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).

Presentation
Cutaneous patch.Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with 'capsaicin 8%'

Indications
Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

Adult Dosage
Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful area should be determined by the physician and marked on the skin. Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia). Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain.The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection.Patches should not be held near eyes or mucous membranes.Direct contact with Qutenza, used gauze or used cleansing gel should be avoided.If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave). The treatment area(s) should be gently washed with soap and water. Following hair removal and washing, the skin should be thoroughly dried.The treatment area should be pre-treated with a topical anaesthetic prior to application of Qutenza to reduce application related discomfort. The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm. The topical anaesthetic should be used in accordance with the product's instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%) or lidocaine (2.5%)/prilocaine (2.5%) for 60 minutes.Qutenza is a single use patch and can be cut to match the size and shape of the treatment area. Qutenza should be cut prior to removal of the release liner. The release liner should NOT be removed until just prior to application. There is a diagonal cut in the release liner to aid in its removal. A section of the release liner should be peeled and folded and the adhesive side of the printed patch placed on the treatment area. The patch should be held in place. The release liner should slowly and carefully be peeled from underneath with one hand while the patch should simultaneously be smoothed onto the skin with the other.To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be used.The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the risk of aerosolisation of capsaicin. After removal of Qutenza, cleansing gel should be applied liberally to the treatment area and left on for at least one minute. Cleansing gel should be wiped off with dry gauze to remove any remaining capsaicin from the skin. After the cleansing gel has been wiped off, the area should be gently washed with soap and water.Acute pain during and following the procedure should be treated with local cooling (such as a cool compress) and oral analgesics (e.g., short-acting opioids).See section 6.6 for the instructions for handling and disposal of the treatment materials.Patients with renal and/or hepatic impairmentNo dose adjustment is required for patients with renal or hepatic impairment.Paediatric populationQutenza is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Child Dosage
Qutenza is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Elderly Dosage
Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful area should be determined by the physician and marked on the skin. Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia). Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of pain.The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection.Patches should not be held near eyes or mucous membranes.Direct contact with Qutenza, used gauze or used cleansing gel should be avoided.If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave). The treatment area(s) should be gently washed with soap and water. Following hair removal and washing, the skin should be thoroughly dried.The treatment area should be pre-treated with a topical anaesthetic prior to application of Qutenza to reduce application related discomfort. The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm. The topical anaesthetic should be used in accordance with the product's instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%) or lidocaine (2.5%)/prilocaine (2.5%) for 60 minutes.Qutenza is a single use patch and can be cut to match the size and shape of the treatment area. Qutenza should be cut prior to removal of the release liner. The release liner should NOT be removed until just prior to application. There is a diagonal cut in the release liner to aid in its removal. A section of the release liner should be peeled and folded and the adhesive side of the printed patch placed on the treatment area. The patch should be held in place. The release liner should slowly and carefully be peeled from underneath with one hand while the patch should simultaneously be smoothed onto the skin with the other.To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be used.The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the risk of aerosolisation of capsaicin. After removal of Qutenza, cleansing gel should be applied liberally to the treatment area and left on for at least one minute. Cleansing gel should be wiped off with dry gauze to remove any remaining capsaicin from the skin. After the cleansing gel has been wiped off, the area should be gently washed with soap and water.Acute pain during and following the procedure should be treated with local cooling (such as a cool compress) and oral analgesics (e.g., short-acting opioids).See section 6.6 for the instructions for handling and disposal of the treatment materials.Patients with renal and/or hepatic impairmentNo dose adjustment is required for patients with renal or hepatic impairment.Paediatric populationQutenza is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Contra Indications
Hypersensitivity to the active substance or to any of the excipients.

Special Precautions
Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas.Qutenza should be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.Care must be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. Exposure of the skin to capsaicin results in transient erythema and burning sensation, with mucous membranes being particularly susceptible. Inhalation of airborne capsaicin can result in coughing or sneezing. Used patches should be disposed of immediately after use in an appropriate medical waste container.If Qutenza comes in contact with skin not intended to be treated, cleansing gel should be applied for one minute and wiped off with dry gauze to remove any remaining capsaicin from the skin surface. After the cleansing gel has been wiped off, the area should be gently washed with soap and water. If burning of eyes, skin, or airway occurs, the affected individual should be removed from the vicinity of Qutenza. Eyes or mucous membranes should be flushed or rinsed with water. Appropriate medical care should be provided if shortness of breath develops.As a result of treatment-related increases in pain, transient increases in blood pressure (on average < 8.0 mm Hg) may occur during and shortly after the Qutenza treatment. Blood pressure should be monitored during the treatment procedure. Patients experiencing increased pain should be provided with supportive treatment such as local cooling or oral analgesics (i.e., short acting opioids). For patients with unstable or poorly controlled hypertension or a recent history of cardiovascular events, the risk of adverse cardiovascular reactions due to the potential stress of the procedure should be considered prior to initiating Qutenza treatment.Patients using high doses of opioids may not respond to oral opioid analgesics when used for acute pain during and following the treatment procedure. A thorough history should be reviewed prior to initiating treatment and an alternative pain reduction strategy in place prior to Qutenza treatment in patients with suspected high opioid tolerance.Though no treatment-related reductions in neurological function have been observed in clinical studies with Qutenza, minor and temporary changes in sensory function (e.g., heat detection) have been reported following administration of capsaicin. Patients with increased risk for adverse reactions due to minor changes in sensory function should be cautious when using Qutenza.There is only limited experience with Qutenza in patients with Painful Diabetic Neuropathy (PDN). Repeated treatments with Qutenza in patients with PDN have not been studied.The cleansing gel for Qutenza contains butylhydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

Interactions
No formal interaction studies with other medicinal products have been performed as only transient low levels of systemic absorption have been shown to occur with Qutenza.

Adverse Reactions
Of the 1,327 patients treated with Qutenza in randomized controlled trials, 883 (67%) reported adverse reactions considered related to the medicinal product by the investigator. The most commonly reported adverse reactions were transient local applications site burning, pain, erythema and pruritus. Adverse reactions were transient, self-limited and usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 0.8% for patients receiving Qutenza and 0.6% for patients receiving control.In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with PHN and painful HIV-AN, are listed by system organ class and frequency: very common ( 1/10), common ( 1/100 to < 1/10) and uncommon ( 1/1,000 to < 1/100).Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.Table 1: Treatment-emergent related adverse reaction incidence in controlled trialsSystem organ class and frequencyAdverse reactionInfections and infestationsUncommonHerpes zosterNervous system disordersUncommonDysgeusia, hypoesthesia, burning sensationEye disordersUncommonEye irritationCardiac disordersUncommonFirst degree atrio-ventricular (AV) block, tachycardia, palpitationsVascular disordersUncommonHypertensionRespiratory, thoracic and mediastinal disordersUncommonCough, throat irritationGastrointestinal disordersUncommonNauseaSkin and subcutaneous tissue disordersUncommonPruritusMusculoskeletal and connective tissue disordersUncommonPain in extremity, muscle spasmsGeneral disorders and administration site conditionsVery commonApplication site pain, application site erythemaCommonApplication site pruritus, application site papules, application site vesicles, application site oedema, application site swelling, application site drynessUncommonApplication site urticaria, application site paresthesia, application site dermatitis, application site hyperesthesia, application site inflammation, application site reaction, application site irritation, application site bruising, peripheral oedemaInvestigationsUncommonIncreased blood pressureNo treatment-related reductions in neurological function, as eva luated by Quantitative Sensory Testing (QST) and neurological examinations, have been observed during clinical studies in patients with peripheral neuropathic pain. Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in healthy volunteer studies.

Manufacturer
Astellas Pharma Ltd

Drug Availability
POM – Prescription Only Medicine

Updated
22 November 2011