4.1. Therapeutic indications

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

4.2. Posology and method of administration

The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.

Posology

The cutaneous patch should be applied to the most affected skin areas (using up to a maximum of 4 patches). This area should be determined by the physician or by a healthcare professional 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, painful diabetic peripheral 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 peripheral neuropathic pain. Re-treatment after less than 90 days can be considered for individual patients only after a careful assessment by the physician (see also section 5.1). A minimum interval of 60 days between treatments is to be observed.

It is recommended to treat sufficiently long and to reassess effectiveness on a case-by-case basis after 3 treatments.

The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of Qutenza to reduce potential application related discomfort. The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm. Topical anaesthetics should be removed prior to applying Qutenza and the skin washed and dried thoroughly.

Renal and/or hepatic impairment

No dose adjustment is required for patients with renal or hepatic impairment.

Paediatric population

The safety and efficacy of Qutenza in children from birth to 18 years has not been established. No data are available.

Method of administration

Cutaneous use only.

Precautions to be taken before handling or administering the medicinal product

It is advisable to administer Qutenza in a well ventilated treatment area.

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. Use of a mask and protective glasses is recommended , particularly during application and removal of the patch.

These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas. This may result in transient erythema and burning sensation (with mucous membranes being particularly susceptible), eye pain, eye and throat irritation and cough.

Patches should not be held near eyes or mucous membranes.

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.

Instructions for use

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 that there is complete contact between the patch and the skin, with no air bubbles and no moisture.

When treating feet, Qutenza patches can be wrapped around the dorsal, lateral and plantar surfaces of each foot to completely cover the treatment area.

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.

Patients experiencing pain during and after patch application should be provided with supportive treatment (see section 4.4)

For instructions on handling and disposal of the treatment materials see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Dermal assessment

Qutenza must 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. In patients with painful diabetic peripheral neuropathy, a careful visual examination of the feet should be undertaken prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency.

Sensory function

Reductions in sensory function have been reported following administration of Qutenza. Decreases in sensory functions are generally minor and temporary (including to thermal and sharp stimuli), however, a single case of persistent hypoesthesia has been reported in clinical studies in painful diabetic neuropathy. For this case a relationship with Qutenza could not be excluded. Caution should be exercised in patients with reduced sensation in the feet and in those at increased risk for such changes in sensory function. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory loss to prior to each application of Qutenza. If sensory loss is detected or worsens, Qutenza treatment should be reconsidered.

Monitoring and management of application site reactions

Application site reactions, such as transient local applications site burning, pain, erythema and pruritus are common or very common. In addition, there have been reported cases of burns, including second-and third-degree burns, in patients treated with capsaicin patches. (see section 4.8). In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn.

Unintended exposure

Unintended exposure to capsaicin may cause irritation of eyes, mucous membranes, respiratory tract, and skin in patients and healthcare professionals. Healthcare professionals should ensure that the recommended protective measures as outlined in Section 4.2 are applied appropriately.

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 capsaicin comes in contact with eyes or mucous membranes, these should be flushed or rinsed with cold water. If irritation of airways, eyes or mucous membranes occurs, the affected individual should leave the Qutenza treatment area. Appropriate medical care should be provided if shortness of breath develops. If respiratory irritation (see also Section 4.8) worsens or does not resolve, the affected individual should carefully consider being re-exposed to Qutenza.

Increase in blood pressure

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. For patients with unstable or poorly controlled hypertension or a history of cardiovascular disease, the risk of adverse cardiovascular events due to the potential stress of the procedure should be considered prior to initiating Qutenza treatment. Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

Treatment-related discomfort

Patients experiencing pain during and after patch application should be provided with supportive treatment such as local cooling (such as a cool compress) or oral analgesics.

Cleansing gel

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.

4.5. Interaction with other medicinal products and other forms of interaction

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.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of capsaicin in pregnant women.

Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the likelihood that Qutenza increases the risk of developmental abnormalities when given to pregnant women is very low. However, caution should be exercised when prescribing to pregnant women.

Breast-feeding

It is unknown whether capsaicin/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk (for details see 5.3).

A risk to the newborns/infants cannot be excluded.

Breast-feeding should be discontinued during treatment with Qutenza.

Fertility

There is no data in humans available on fertility. A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).

4.7. Effects on ability to drive and use machines

Qutenza has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus.

Tabulated list of adverse reactions

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 postherpetic neuralgia (PHN), painful Human Imunodeficiency Virus – Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1: Tabulated list of adverse reactions

System organ class and frequency

Adverse reaction

Infections and infestations

Uncommon

Herpes zoster

Nervous system disorders

Common

Burning sensation

Uncommon

Dysgeusia, hypoaesthesia

Eye disorders

Uncommon

Eye irritation

Cardiac disorders

Uncommon

First degree atrio-ventricular (AV) block, tachycardia, palpitations

Vascular disorders

Common

Hypertension

Respiratory, thoracic and mediastinal disorders

Common

Cough

Uncommon

Throat irritation

Gastrointestinal disorders

Common

Nausea

Skin and subcutaneous tissue disorders

Common

Pruritus

Musculoskeletal and connective tissue disorders

Common

Pain in extremity, muscle spasms

General disorders and administration site conditions

Very common

Application site pain, application site erythema

Common

Application site pruritus, application site papules, application site vesicles, application site oedema, application site swelling, application site dryness, peripheral oedema

Uncommon

Application site urticaria, application site paraesthesia, application site dermatitis, application site hyperaesthesia, application site inflammation, application site reaction, application site irritation, application site bruising

Investigations

Common

Increased blood pressure

Injury, poisoning and procedural complications

Not known

Application site burns (including second-and third-degree burns), accidental exposure (including eye pain, eye and throat irritation and cough)

Description of selected adverse reactions

Adverse reactions were transient, self limiting and usually mild to moderate in intensity. In controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% for patients receiving control.

Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in clinical trials with healthy volunteers.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No case of overdose has been reported. Qutenza is required to be administered by a physician or under the supervision of a physician. Therefore, overdosing is unlikely to occur. Overdose may be associated with severe application site reactions, e.g. application site pain, application site erythema, application site pruritus. In case of suspected overdose, the patches should be removed gently, cleansing gel should be applied for one minute and then wiped off with dry gauze and the area should be gently washed with soap and water. Supportive measures should be taken as clinically needed. There is no antidote to capsaicin.