Aminolevulinic Acid HCl (aminolevulinic acid hydrochloride)
DUSA Pharmaceuticals (Levulan Kerastick); Biofrontera (Ameluz) · Photosensitizing Agent / Photodynamic Therapy (PDT)
What is Aminolevulinic Acid HCl? Aminolevulinic acid hydrochloride (Levulan Kerastick, Ameluz) is a topical photosensitizing agent used with photodynamic therapy (PDT) blue or red light to treat actinic keratoses (AK) and superficial basal cell carcinoma.
About Aminolevulinic Acid HCl
| Brand Name | Aminolevulinic Acid HCl |
| Generic / INN | aminolevulinic acid hydrochloride |
| Drug Class | Photosensitizing Agent / Photodynamic Therapy (PDT) |
| Manufacturer | DUSA Pharmaceuticals (Levulan Kerastick); Biofrontera (Ameluz) |
| Administration | Topical application (stick applicator or gel) |
| FDA Approval | 1999 |
FDA-Approved Uses for Aminolevulinic Acid HCl
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Actinic keratoses (AK) — non-hyperkeratotic face and scalp lesions
- Superficial basal cell carcinoma (sBCC) — Ameluz formulation
- Field cancerization in photodamaged skin
How Does Aminolevulinic Acid HCl Work?
After topical application, aminolevulinic acid is preferentially absorbed by abnormal (pre-cancerous and cancerous) cells and converted intracellularly to protoporphyrin IX (PpIX), a photosensitizer. When the treated area is illuminated with blue light (Levulan, BLU-U) or red light (Ameluz, RhodoLED lamp), PpIX absorbs the light energy, generating reactive oxygen species that destroy the abnormal cells.
Dosage & Administration
Levulan Kerastick: Applied directly to individual AK lesions; left on skin for 14–18 hours, then illuminated with BLU-U blue light for 1,000 seconds. Ameluz gel: Applied to AK field or sBCC; left 3 hours under occlusion, then illuminated with RhodoLED lamp. Exact protocol per FDA prescribing information.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
Severe phototoxic reactions if sun or bright indoor light exposure occurs before or during the incubation period. Protect treated areas from light during incubation. Do not apply to eyes or mucous membranes. Avoid in patients with porphyria or hypersensitivity to porphyrins.
- Severe phototoxic reactions (sun exposure during incubation)
- Porphyria contraindication
- Hypersensitivity reactions
Common Side Effects
- Stinging / burning during light treatment
- Erythema
- Edema
- Crusting
- Scaling
- Pustules
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Store Levulan Kerastick at room temperature 15°C to 25°C (59°F to 77°F). Keep away from light. Ameluz: refrigerate at 2°C to 8°C (36°F to 46°F).
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Aminolevulinic Acid HCl is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Aminolevulinic Acid HCl. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Aminolevulinic Acid HCl
Levulan Kerastick (aminolevulinic acid HCl) is a topical photosensitizer used with blue light (photodynamic therapy) to treat actinic keratoses on the face and scalp. Ameluz (a gel formulation) is also approved for superficial basal cell carcinoma.
After Levulan is applied to the skin, it is absorbed by abnormal cells and converted to a light-sensitive compound (PpIX). When the area is exposed to blue or red light, PpIX generates reactive oxygen species that selectively destroy precancerous and cancerous cells.
Stinging, burning, and discomfort during the light treatment phase are common. Topical anesthetics are sometimes used. Most patients describe the sensation as a burning or tingling during the illumination.
PDT for actinic keratoses is often covered by commercial insurance and Medicare Part B when medically indicated. Prior authorization may be required depending on the plan and the number of lesions.
Related Medications & Conditions
Related Medications
Imiquimod Cream 5% · Fluorouracil Cream (5-FU) · Diclofenac Sodium Gel 3%
Related Conditions
Actinic keratosis (AK) · Superficial basal cell carcinoma · Field cancerization · Photodamaged skin