Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Health care professionals should wear nitrile gloves when handling patches and when cleansing treatment areas (see section 4.2). It is advisable to administer Qutenza in a well ventilated treatment area.
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. 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.
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.
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 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.
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. 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.
Patients experiencing pain during and after patch application should be provided with supportive treatment such as local cooling or oral analgesics (i.e. short acting opioids).
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 put in place prior to Qutenza treatment in patients with suspected high opioid tolerance.
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.
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.
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.
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.
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).
Qutenza has no or negligible influence on the ability to drive and use machines.
Of the 1826 patients treated with Qutenza in randomized controlled trials, 1089 (59.6%) reported adverse reactions considered related to the medicinal product by the investigator. The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus. Adverse reactions were transient, self limiting and usually mild to moderate in intensity. In all controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% 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 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:
Uncommon: Herpes zoster
Common: Burning sensation
Uncommon: Dysgeusia, hypoaesthesia
Uncommon: Eye irritation
Uncommon: First degree atrio-ventricular (AV) block, tachycardia, palpitations
Uncommon: Hypertension
Uncommon: Cough, throat irritation
Uncommon: Nausea
Uncommon: Pruritus
Common: Pain in extremity
Uncommon: Muscle spasms
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
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, peripheral oedema
Uncommon: Increased blood pressure
Not known: Burns second degree, accidental exposure (including eye pain, eye and throat irritation and cough)
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 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 national reporting system listed in Appendix V.
Not applicable.
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