Aminolevulinic acid

What is Ameluz?

• Ameluz (Aminolevulinic acid hydrochloride) a porphyrin precursor, used in photodynamic therapy to treat actinic keratosis.

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Aminolevulinic acid

What are the uses of this medicine?

• Ameluz (Aminolevulinic acid hydrochloride) in combination with photodynamic therapy (PDT) using BF-RhodoLED® or RhodoLED® XL lamp, a narrowband, red light illumination source, is used for treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

How does this medicine work?

• When aminolevulinic acid is taken up by abnormal cells, including cancer cells, and then exposed to certain types of light, it becomes active and kills the cells.
• It may also help find some types of cancer cells when they are exposed to certain types of light.
• Aminolevulinic acid is a type of photosensitizing agent.
• Ameluz photodynamic therapy of AK lesions utilizes photoactivation of topically applied Ameluz resulting from BF-RhodoLED or RhodoLED XL illumination.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to porphyrins.
• Known hypersensitivity to any of the components of Ameluz, which includes soybean phosphatidylcholine.
• Porphyria
• hotodermatoses

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Ameluz.
• It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to photodynamic therapy (PDT).

Is this medicine FDA approved?

• Initial U.S. Approval: 1999

How should this medicine be used?

Recommended dosage:

• Apply gel approximately 1 mm thick and include approximately 5 mm of the surrounding skin.
• Use sufficient amount of gel to cover the single lesions or if multiple lesions, the entire area.
• Application area should not exceed 20 cm2 and no more than 2 grams of Ameluz (one tube) should be used at one time.
• The gel can be applied to healthy skin around the lesions.

Administration:

• Administer Ameluz only by a health care provider.
• Ameluz is for topical use only.
• Photodynamic therapy with Ameluz involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp.
• Retreat lesions that have not completely resolved 3 months after the initial treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gel: 10%

This medicine is available in fallowing brand namesː

• Ameluz

What side effects can this medication cause?

The most common side effects of this medicine include:

• application site erythema
• pain/burning
• irritation
• edema
• pruritus
• exfoliation
• scab
• induration
• vesicles

What special precautions should I follow?

• Hypersensitivity reactions have been reported with the use of Ameluz prior to photodynamic therapy (PDT). Ameluz should be washed off and appropriate therapy instituted.
• Transient Amnestic Episodes have been reported with use of Ameluz in combination with PDT. If patients experience amnesia or confusion, discontinue treatment and contact healthcare provider.
• BF-RhodoLED or RhodoLED XL lamp may cause eye irritation, glare, or injury. Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED or RhodoLED XL lamp.
• Ameluz increases photosensitivity. Protect treated lesions from sunlight exposure for 48 hours post treatment.
• Ameluz has not been tested on patients with inherited or acquired coagulation disorders. Special care should be taken to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders.
• Ameluz can cause ophthalmic adverse reactions. Ameluz is intended for topical use only. Do not apply Ameluz into the eyes. Rinse eyes with water in case of accidental contact.
• Ameluz can cause mucous membrane irritation. Ameluz is intended for topical use only. Do not apply Ameluz to the mucous membranes. Rinse with water in case of accidental contact.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Ameluz use in pregnant women to inform a drug associated risk.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 18 have not been established. AK is not a condition generally seen in the pediatric population.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• AMINOLEVULINIC ACID HYDROCHLORIDE

Inactive ingredients:

• XANTHAN GUM
• LECITHIN, SOYBEAN
• POLYSORBATE 80
• MEDIUM-CHAIN TRIGLYCERIDES
• ISOPROPYL ALCOHOL
• SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
• SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
• PROPYLENE GLYCOL
• SODIUM BENZOATE
• WATER

Who manufactures and distributes this medicine?

• Manufacturer: Biofrontera Pharma GmbH
• Distributor: Biofrontera Inc.

What should I know about storage and disposal of this medication?

• Store Ameluz in a refrigerator, 2°C – 8°C (36°F – 46°F).
• Excursions permitted to 15°C – 30°C (59°F – 86°F).
• After opening, Ameluz can be stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed.

• Dailymed label info on Aminolevulinic acid
• FDA Aminolevulinic acid

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