Aminolevulinic Acid Topical

Aminolevulinic Acid Topical is a topical medication used for the treatment of actinic keratoses on the face, scalp or upper extremities.

• Aminolevulinic Acid Topical  is available under the following different brand names: Ameluz, Levulan Kerastick

Common side effects of Aminolevulinic Acid Topical include:

• pain, burning, redness, or swelling of treated skin,
• itching, stinging, tingling, or prickly feeling,
• scaling or crusting of the skin,
• headache,
• chills, and
• puffy eyelids

Serious side effects of Aminolevulinic Acid Topical include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat, and
• severe stinging or burning that lasts longer than 4 weeks

Rare side effects of Aminolevulinic Acid Topical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Topical gel (Ameluz)

• 10%

Topical solution (Levulan Kerastick)

• 20%

Actinic Keratosis

Adult dosage

• Levulan Kerastick
  • One application of the levulan kerastick topical solution and one dose of illumination per treatment region per 8-week treatment session. 
  • Each individual levulan kerastick applicator should be used for only one patient.
• Ameluz
  • Treat single lesions or an entire field affected by multiple lesions with Ameluz, in combination with red light photodynamic therapy (PDT).

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Aminolevulinic Acid Topical has severe interactions with no other drugs.
• Aminolevulinic Acid Topical has serious interactions with at least 78 other drugs.
• Aminolevulinic Acid Topical has moderate interactions with no other drugs.
• Aminolevulinic Acid Topical has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to porphyrins
• Hypersensitivity to any gel components, which includes soybean phosphatidylcholine
• Porphyria; drug may cause uncontrolled phototoxic effects
• Known photodermatoses of varying pathology and frequency (eg, metabolic disorders [aminoaciduria], idiopathic or immunological disorders [polymorphic light reaction], genetic disorders [xeroderma pigmentosum], and diseases precipitated or aggravated by exposure to sunlight [lupus erythematoides or pemphigus erythematoides])
• Levulan Kerastick
  • Cutaneous photosensitivity at wavelengths of 400-450 nm

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aminolevulinic Acid Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aminolevulinic Acid Topical?”

Cautions

• Ameluz
  • Transient amnestic episodes reported during postmarketing use of topical gel in combination with photodynamic therapy
  • BF-RhodoLED lamp may cause eye irritation, glare, or injury; protective eye equipment must be used by the patient, healthcare providers and any person present during the illumination period
  • Has not been tested on patients with inherited or acquired coagulation disorders; special care should be taken to avoid bleeding during lesion preparation
  • Eyelid edema and mucous membrane irritation reported; rinse eyes with water in case of accidental contact
  • Several cases of hypersensitivity reported during postmarketing use prior to PDT illumination; if allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy; inform patients and their caregivers that therapy may cause hypersensitivity, potentially including severe courses (anaphylaxis)
• Levulan Kerastick
  • Topical solution contains alcohol and is intended for topical use only; irritation may occur if applied to eyes or mucus membranes; do not apply to eyes or to mucous membranes; excessive irritation may be experienced if this product is applied under occlusion for more than 3 hours
  • The treatment site will become photosensitive and patients should avoid exposure of photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours; exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions; before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves; because of potential for skin to become photosensitized, the topical solution should be used by a qualified health professional to apply the drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions
  • Temporary memory problems reported during treatment in combination with BLU-U Blue Light Photodynamic Therapy Illuminator; inform the healthcare provider right away if problems with memory, confusion, or disorientation occur during treatment
  • Safety and efficacy are not established in patients with inherited or acquired coagulation defects

Pregnancy and Lactation

• Ameluz: No available data
• Levulan Kerastick: Limited available data with topical solution use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
• Lactation
  • Unknown if distributed in human breast milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition