aminolevulinic acid

Contraindicated in:

Hypersensitivity;
History of cutaneous photosensitization;
Photodermatoses;
Porphyria;
Hypersensitivity to porphyrins.

Use Cautiously in:

Acquired or inherited coagulation defects;
OB: Safety not established in pregnancy; systemic absorption expected to be negligible with minimal fetal exposure;
Lactation: Not expected to appear in breast milk due to negligible systemic absorption;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Local: edema, burning, pruritus, stinging, oozing , scaling, ulceration

Neuro: amnesia (transient)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of other photosensitizing agents, including thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, or tetracyclines, may ↑ intensity of the photosensitizing reaction.

Availability ⬆ ⬇

Topical gel (Ameluz): 10%
Topical solution (Levulan): 20%

Route/Dosage ⬆ ⬇

(Adults ): Ameluz: Apply gel ~1 mm thick to actinic keratosis and to ~5 mm of surrounding skin; Levulan: One application via the Kerastick system (contains 354 mg of aminolevulinic acid), followed 3 hr (for upper extremities) or 14–18 hr (for face or scalp) later by blue light illumination; may repeat in 8 wk if lesions not completely resolved.

US Brand Names ⬆ ⬇

Ameluz, Levulan Kerastick

Action ⬆ ⬇

When applied topically, produces an accumulation of protoporphyrin IX, which, when exposed to specific wavelengths of light and energy in the presence of oxygen, produces a cytotoxic photodynamic reaction.

Therapeutic effects:

Resolution of actinic keratoses.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: photosensitizers

Pharmacokinetics ⬆ ⬇

Absorption: Intended for topical application only.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(resolution of keratoses )

ROUTE	ONSET	PEAK	DURATION
Topical	unknown	4–8 wk*	unknown

*May take up to 12 wk.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Explain importance of following treatment schedule after application. Instruct patient to notify health care professional if unable to return for blue light treatment during prescribed period.
Caution patient to avoid sunlight or bright indoor light (examination lamps, operating room lamps, tanning beds, lights at close proximity) between application and exposure to activating light. Skin will be photosensitive during this period. Exposure may result in stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Protection with wide-brimmed hat, long-sleeved shirt, and gloves of light opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.
Instruct patient to avoid occlusive dressings; may cause excessive irritation.
Advise patient to keep treated actinic keratoses dry and out of bright light between application and exposure to activating light.
Advise patient and caregiver to notify health care professional if patient develops amnesia, confusion, disorientation, or signs of hypersensitivity (anaphylaxis, rash, itching, redness) following treatment. Seek emergency medical attention if needed.
Inform patient that blue light is low intensity and will not heat skin. Inform patient that they may experience tingling, stinging, prickling, or burning sensations of the treated lesions. Actinic keratoses and surrounding skin will redden, and some scaling and swelling may occur. These lesion changes are temporary and should be completely resolved by 4 wk after treatment.
Instruct patient to contact health care professional if they are unable to return for blue light therapy within 14–18 hr for face or scalp or within 3 hr for upper extremity. Caution patient to avoid exposure of photosensitized lesions to sunlight or prolonged or intense light for >40 hr. If stinging and/or burning is noted, exposure to light should be reduced.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or expected or if breastfeeding.

Pronunciation ⬆ ⬇

a-mee-noe-lev-yoo-LIN-ic A-sid

Code ⬆

NDC Code

67308- DUSA Pharmaceuticals, Inc.
- 67308-101- LEVULAN KERASTICK
  - 67308-101-01- 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

67308- DUSA Pharmaceuticals, Inc.
- 67308-101- LEVULAN KERASTICK
  - 67308-101-02- 2 APPLICATOR in 1 CARTON (67308-101-02) > 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

67308- DUSA Pharmaceuticals, Inc.
- 67308-101- LEVULAN KERASTICK
  - 67308-101-06- 6 APPLICATOR in 1 CARTON (67308-101-06) > 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

70621- Biofrontera Inc.
- 70621-101- AMELUZ
  - 70621-101-01- 1 TUBE in 1 PACKAGE (70621-101-01) > 2 g in 1 TUBE

70621- Biofrontera Inc.
- 70621-101- AMELUZ
  - 70621-101-10- 1 TUBE in 1 PACKAGE (70621-101-10) > 2 g in 1 TUBE

70621- Biofrontera Inc.
- 70621-101- AMELUZ
  - 70621-101-30- 1 TUBE in 1 PACKAGE (70621-101-30) > 2 g in 1 TUBE

71469- NX DEVELOPMENT CORP
- 71469-231- GLEOLAN
  - 71469-231-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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Indications ⬇

Contraind./Precautions ⬆ ⬇