Qutenza 179mg Cutaneous Patch

EMA approval regarding the deletion of the local representative. Approved on 01/12/2023.

EMA approval of Type II variation impacting SmPC sections 4.2 and 5.1.

Updated to Prescribers guide following approval of variation in accordance with CCDS version 4.0.

Change to section 2 - for allergic reaction to capsaicin and also chili peppers (editiorial change)

Change to section 4 - possible side effects with reference to burns and its management

Updates to Section 4.4 and 4.8 addition of third degree burns

Update to Section 6.5 exchange of primary packaging material

Both changes approved by EMA

Updated to delete the explicit reference to opioids in the SmPC and to update the section describing unintended exposure to capsaicin. 

Updated to delete the explicit reference to opioids in the SmPC and to update the section describing unintended exposure to capsaicin. 

New text shown in italics and underlined

Section 3:

Your doctor or nurse will mark the most painful areas on your skin with a pen or marker.

....

Qutenza therapy may be repeated at 90-day intervals, if necessary. If you experience insufficient pain relief or pain returns earlier, please consult your doctor.

New text shown in italics and underlined

Section 4.2

Posology:

The painful area can be determined by the physician or by a healthcare professional and marked on the skin.

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.

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Section 5.1

Clinical efficacy and safety

Efficacy of a single 30‑minute application of Qutenza to the feet has been shown in controlled clinical trials of 12 weeks duration conducted in patients with painful Human Imunodeficiency Virus – Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy (pDPN).

The average pain reduction after single application of Qutenza compared to baseline at week 2 to 12 across the pivotal trials ranged between -22.8% and -32.3%, compared to a range of -10.7% to -25.0% for the control patches. Responder rates (response defined as a 30% decrease in average pain score from baseline) ranged between 34% and 47%, compared to a range of 18% to 36% for the control patches. These results were statistically significant versus low dose capsaicin (PHN and HIV-AN) or placebo (pDPN).

…..

Consistent and reproducible efficacy ​​and tolerability was demonstrated with repeated treatments during a 52-week period in two clinical trials (STRIDE and PACE). In these two trials, one in pDPN patients and one in patients with HIV-AN, Post Traumatic Nerve Injury (PNI) and PHN, the mean time (Standard Deviation) to retreatment was 68.4 (23.31) and 107 (43.58) days respectively. In these trials 25% of patients had a retreatment time shorter than 61.5 and 78.8 days respectively and 25% of patients had a retreatment time longer than 64.6 and 118.7 days respectively. A frequency increase of up to approximately 5% of known application site reactions, such as pain and burning sensation, was reported in patients retreated with Qutenza earlier than 90 days.

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Section 9:

Date of last renewal changed to 28 March 2019

Section 4.8:

Update to the frequency of adverse reactions from Uncommon to Common

Hypertension

Cough

Nausea

Pruritus

Muscle spasms

Peripheral oedema

Increased blood pressure

Update to adverse event reporting to HPRA

Frequency of adverse reactions changed from Uncommon to Common for:

Hypertension

Cough

Nausea

Pruritus

Muscle spasms

Peripheral oedema

Increased blood pressure

Patient guide made avaiable on medicines.ie

Prescribers administration guide made avaiable on medicines.ie

(new text ; deletions)

Section 4.1:

Amended as follows:

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.

Section 4.2:

The topical anaesthetic or oral analgesic should be used in accordance with the medicinal product’s instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol. The Topical anaesthetics cream should be removed prior to applying Qutenza and the skin washed and dried thoroughly.

...

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

..

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

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).

Section 4.4:

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.

Dermal assessment

Qutenza should must be used only on dry, intact (unbroken) skin and not on the face, above the hairline of the scalp......

.....

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 (i.e. short acting opioids).

Section 4.8:

Summary of the safety profile

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.

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.

Section 6.1:

Backing layer

Polyethylene Terephthalate (PET) Film, inner side siliconized polyester backing film

printing ink containing Pigment White 6

Removable protective layer (release liner)

polyester film, fluoropolymer-coated  release liner

Section 6.5:

The Qutenza cutaneous patch is stored in a paper coated aluminium foil sachet with polyacrylnitril acrylnitrile-acrylic acid copolymer heat seal layer.

The cleansing gel is supplied in a high density polyethylene tube with a polypropylene cap.

Qutenza is available in a kit packs containing one or two sachets of individually sealed Qutenza cutaneous patches and a 50 g tube of cleansing gel.

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Section 10: Date of revision of the text
04 May 2017

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

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).

4.2     Posology and method of administration

4.2     Posology and method of administration

Posology

The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician. Direct contact with Qutenza, used gauze or used cleansing gel should be avoided: See below Method of administration - Precaution to be taken before manipulating or administering the product.

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.

 Method of administration

Precautions to be taken before manipulating or administering the product

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 mask and protective glasses should also be considered, particularly during the 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.

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.

Used patches should be disposed of immediately after use in an appropriate medical waste container.

 4.4     Special warnings and precautions for use

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. See section 4.2, Method of administration - Precaution to be taken before manipulating or administering the product.

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 (see section 6.6).

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 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.

Diabetic Neuropathy

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.

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.

4.6     Fertility, pregnancy and lactation

Pregnancy

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

4.8     Undesirable effects

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) and not known (cannot be estimated from the available data).

6.6     Special precautions for disposal and other handling

Health care professionals should wear nitrile gloves when handling patches and cleansing treatment areas. The use of mask and protective glasses may also be considered, see section 4.2.

10.     DATE OF REVISION OF THE TEXT

         Astellas Pharma Europe B.V.
            Elisabethhof 19

2353 EW Leiderdorp

Sylviusweg 62

2333 BE Leiden

Netherlands