Ameluz - patient leaflet, side effects, dosage

1. What Ameluz is and what it is used for

Ameluz contains the active substance 5-aminolaevulinic acid. It is used to treat:

• slightly palpable to moderately thick actinic keratoses or entire fields affected by actinic keratoses in adults. Actinic keratoses are certain changes in the outer layer of the skin that can lead to skin cancer.
• superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Basal cell carcinoma is a skin cancer that can cause reddish, scaly patches or one or several small bumps that bleed easily and do not heal.

After application, the active substance of Ameluz becomes a photoactive substance which accumulates in affected cells. Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells. This therapy is known as photodynamic therapy (PDT).

2. What you need to know before you use Ameluz

Do not use Ameluz

• if you are allergic to

• – 5-aminolaevulinic acid or any of the other ingredients of this medicine (listed in section 6)

• – photoactive substances known as porphyrins

• – soya or peanuts

• if you have impaired formation of red blood pigment called porphyria
• if you have other skin conditions caused by, or made worse by, exposure to light

Warnings and precautions

Talk to your doctor before using Ameluz.

• In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
• The use of Ameluz is not recommended if you use immunosuppressants.
• Avoid applying Ameluz

• – to bleeding lesions

• – into eyes or to mucous membranes

• – on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.

• Discontinue any UV-therapy before treatment.
• Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.

Children and adolescents

Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.

Other medicines and Ameluz

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as

• St. John’s wort or its preparations: medicines to treat depression
• griseofulvin: a medicine to treat fungal infections
• medicines to increase water output through your kidneys with active substance names mostly ending in “thiazide” or “tizide”, such as hydrochlorothiazide
• certain medicines to treat diabetes, such as glibenclamide, glimepiride
• medicines to treat mental disorders, nausea or vomiting with active substance names mostly ending in “azine”, such as phenothiazine
• medicines to treat bacterial infection with active substance names beginning with “sulfa” or ending in “oxacin” or “cycline”, such as tetracycline

Pregnancy and breast-feeding

Ameluz is not recommended during pregnancy, due to insufficient knowledge.

Breast-feeding should be interrupted for 12 hours after application of Ameluz.

Driving and using machines

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

Ameluz contains

• 2.4 mg sodium benzoate (E211) in each gram of gel. Sodium benzoate may cause local

irritation.

• soybean phosphatidylcho­line: If you are allergic to peanut or soya, do not use this medicine.
• propylene glycol: May cause skin irritation.

3. How to use Ameluz

Ameluz is only used on the skin. A therapy session can be administered for single or multiple lesions, or entire treatment fields. The illumination source for PDT treatment of actinic keratoses lesions or fields can be daylight or a red-light lamp. Your doctor will decide which treatment option to use, depending on your lesions.

The illumination source for PDT of actinic keratosis in the body regions trunk, neck and extremities is a narrow-spectrum red-light. There are no data of efficacy of broader spectrum lamps or daylight PDT in these body regions.

The illumination source for PDT of basal cell carcinoma is always a red-light lamp.

Treatment of lesions or fields of actinic keratoses and basal cell carcinoma using a red-light lamp

Preparation of the lesions

The application area is first wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are then carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel

Ameluz is applied to form a film of about 1 mm thickness to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.

Avoid any contact with the eyes, nostrils, mouth, ears, mucous membrane or bleeding lesions. A distance of at least 1 cm is to be maintained. Rinse with water if such contact occurs.

The gel is allowed to dry for approximately 10 minutes before placing a light-tight dressing over the treatment site. The dressing is removed after 3 hours. The remaining gel is wiped off.

Illumination using a red-light lamp

The use of Ameluz requires specific knowledge in photodynamic therapy as it may necessitate the use of a red-light lamp.

Immediately after cleaning, the entire treated area is illuminated using a red light source. Efficacy and side effects such as temporary pain are dependent on the light source used. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. All should wear suitable protective goggles during illumination. There is no need to protect healthy untreated skin.

Treatment of lesions and fields of actinic keratoses with daylight

Considerations before treatment

Only use daylight treatment if the weather is suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C). If the weather is rainy, or is likely to become so, you should not use daylight treatment.

Preparation of the lesions

Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment. Only use sunscreen with chemical filters and sun protection factor 30 or higher. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide, as these inhibit light absorption and may therefore impact efficacy.

Then wipe the application area with an alcohol-soaked cotton pad to degrease the skin. Carefully removed scales and crusts and gently roughen all lesion surfaces. Take care to avoid bleeding.

Application of the gel

Apply Ameluz to form a thin layer to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.

Avoid any contact with the eyes, nostrils, mouth, ears, mucous membrane or bleeding lesions, maintaining a distance of at least 1 cm. Rinse with water if such contact occurs.

A light-tight dressing is not necessary. Do not wipe off the gel during the entire daylight treatment session.

Illumination using daylight for actinic keratosis treatment

If weather conditions are suitable (please see above; Considerations before treatment), you should go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight. Taking shelter in the shade in hot weather is acceptable. If the time outdoors is interrupted, you should compensate this with a longer illumination time. After the two hour light exposure, wash off the remaining gel.

Number of treatments

• Lesions and fields of actinic keratoses are treated with one session.
• Basal cell carcinoma is treated with two sessions, with an interval of one week between

sessions.

The treated lesions should be evaluated 3 months after treatment. Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects at the application site occur in about 9 out of 10 users and indicate that the affected cells are responding to treatment.

Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after. However, in some cases they may persist for 1 to 2 weeks or even longer. In rare cases, interruption or discontinuation of illumination may be necessary. After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.

The side effects listed below have been reported when using Ameluz with a red-light lamp. The study of Ameluz using daylight showed similar types of side effects; however, with lower intensity. Some reactions at the application site have been observed before the use of light.

Very common: may affect more than 1 in 10 people

• reactions at the application site

• – skin reddening

• – pain (incl. burning)

• – irritation

• – itching

• – tissue swelling caused by excess fluid

• – scab

• – scaling of the skin

• – hardening

• – abnormal sensation, such as pricking, tingling or numbness

Common: may affect up to 1 in 10 people

• reactions at the application site

• – vesicles

• – discharge

• – abrasion

• – other reaction

• – discomfort

• – increased sensitivity to pain

• – bleeding

• – warmth

• headache

Uncommon: may affect up to 1 in 100 people

• reactions at the application site

• – change of colour

• – pustules

• – ulcer

• – swelling

• – inflammation

• – eczema with pustules

• – allergic reaction1

• blister
• dry skin
• eyelid swelling caused by excess fluid, blurred vision or visual impairment
• unpleasant, abnormal sense of touch
• chills
• feeling hot, fever, hot flush
• temporary memory loss1
• pain
• nervousness
• wound secretion
• fatigue
• rash, red or purple spots on the body
• ulcer
• swelling
• skin tightness

1 Data from post-marketing

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ameluz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Keep the tube tightly closed after first opening. Discard open tubes 12 weeks after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ameluz contains

• The active substance is 5-aminolaevulinic acid.

• 1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).

• The other ingredients are:

disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, propylene glycol, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcho­line, triglycerides medium-chain, xanthan gum. See section 2.

What Ameluz looks like and contents of the pack

Ameluz is a white to yellowish gel.

Each carton contains one aluminium tube with 2 g gel closed with a polyethylene screw cap.

Marketing Authorisation Holder

Biofrontera Bioscience GmbH

Hemmelrather Weg 201

51377 Leverkusen, Germany

Tel: +49 214 87632 66, Fax: +49 214 87632 90

Email:

Manufacturer

Biofrontera Pharma GmbH

Hemmelrather Weg 201

51377 Leverkusen, Germany

Tel: +49 214 87632 66, Fax: +49 214 87632 90

Email:

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Tel: 900 974943

Polska

Biofrontera Pharma GmbH

Niemcy

Tel.: +49 214 87632 66

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

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