QUTENZA

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. g. g. postherpetic neuralgia). Qutenza treatments may be repeated every 90 days, as warranted by the persistence or return of peripheral neuropathic pain.

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.

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.

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. 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. 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.

1.