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Ameluz

aminolevulinic acid
Used for Actinic Keratosis
Used for Actinic Keratosis

Ameluz is aminolevulinic acid 10% gel, a photosensitizing agent that's used to treat actinic keratoses (AK) (sun spots) in adults. Your provider will apply Ameluz (aminolevulinic acid) to the spots on the skin at their office or clinic. Afterwards, they'll use red light photodynamic therapy (PDT) to activate the medication to destroy the cells that cause AK. The most common side effects of Ameluz (aminolevulinic acid) include redness and pain around the treated skin areas.

Reviewed by:
reviewer
Connie Zheng, PharmD
reviewer
Kristianne Hannemann, PharmD
Last reviewed on December 13, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageContraindicationsAlternativesReferencesPricesMedicare
basics-icon

What is Ameluz (aminolevulinic acid)?

What is Ameluz (aminolevulinic acid) used for?

  • Mild-to-moderate actinic keratoses on the face and scalp (in combination with photodynamic therapy)

How Ameluz (aminolevulinic acid) works

Ameluz (aminolevulinic acid) is a photosensitizing agent. It's activated ("turned on") by light and kills skin cells that cause actinic keratoses.

Are you looking for information on Levulan Kerastick (aminolevulinic acid) instead?

Drug Facts

Common BrandsAmeluz
Drug ClassTopical skin product
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Ameluz (aminolevulinic acid)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Warmth or redness (92%)
  • Pain and burning (92%)
  • Irritation (72%)
  • Swelling (35%)
  • Itching (34%)
  • Peeling skin (19%)
  • Scab (19%)
  • Thickening of the skin (12%)
  • Fluid-filled blisters (12%)

Other Side Effects

  • Prickly or tingling sensation
  • Pain
  • Discomfort
  • Skin damage
  • Bleeding
  • Pus-filled bumps

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Severe allergic reaction: trouble breathing, swelling of the lips, tongue, throat, or face, rash

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

  • Chills
  • Headache
  • Mild skin irritation, redness, or dryness
  • Sensitivity to light
pros-and-cons

Pros and cons of Ameluz (aminolevulinic acid)

thumbs-up

Pros

Only needs one or two treatments

Many people had clear skin 3 months after the first treatment

After medication is applied, only need to wait 3 hours before PDT (compared to 14 to 18 hours with Levulan)

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Cons

Only approved to treat AK on the face and scalp, not arms or hands

Not a good option for people allergic to soybeans

Must avoid sunlight or bright indoor light for about 48 hours after treatment

pharmacist-tips

Pharmacist tips for Ameluz (aminolevulinic acid)

pharmacist

  • Make sure to bring a wide-brimmed hat to your appointment so you can protect the treated areas from the sun or bright indoor light after you leave. You'll need to avoid light for about 2 days to minimize burning and stinging in these areas.

    • If, for whatever reason, you're not able to receive light therapy after Ameluz (aminolevulinic acid) is applied, let your provider know. They'll ask you to wash off the gel with saline and water. You'll still need to protect the treated areas from light for about 2 days.

      • Some medications, such as certain antibiotics or acne medication, can make your skin even more sensitive to sunlight during treatment with Ameluz (aminolevulinic acid). Tell your provider all of the medications you're taking so they can check if they're safe to take with Ameluz (aminolevulinic acid).

        • After treatment with Ameluz (aminolevulinic acid), you can expect some skin reddening, scabbing, and pain at the application site. These side effects are temporary and should only last for up to 4 days for most people. But sometimes, they can last 2 weeks or longer. If anything concerns you, call your provider to discuss.

          • If your sun spots don't go away within 3 months, contact your provider. You might need another treatment with Ameluz (aminolevulinic acid).

            • It isn't known if Ameluz (aminolevulinic acid) causes harm to unborn babies or breastfed babies. If you're pregnant or breastfeeding, discuss the risks and benefits for you and your baby with your provider.

              faqs

              Frequently asked questions about Ameluz (aminolevulinic acid)

              Which is more effective, Levulan Kerastick or Ameluz?
              Ameluz (aminolevulinic acid 10% gel) and Levulan Kerastick (aminolevulinic acid 20% topical solution) are both used along with PDT to treat actinic keratoses (AK). Ameluz is FDA-approved to be used with red light, while Levulan Kerastick is approved for use with blue light. There aren't many studies directly comparing the two treatments. One study suggests that both work similarly well for treating AK, but Levulan Kerastick is more likely to cause skin irritation. Keep in mind that the researchers in this study used blue light therapy with both treatments and followed directions that differed from those approved by the FDA. If you have more questions about the differences between Ameluz and Levulan Kerastick, talk with your provider.
              How long does it take for Ameluz (aminolevulinic acid) to work?
              You might start to notice your skin improving a few weeks after Ameluz (aminolevulinic acid) treatment. In studies, 91% of people who used Ameluz (aminolevulinic acid) had clear skin 3 months after their treatment, compared to 22% of the people who received placebo. If there's not much improvement after 3 months, your provider might consider giving you another treatment.
              Can Ameluz (aminolevulinic acid) be used with blue light?
              Ameluz (aminolevulinic acid) is only FDA-approved to be used with red light (BF-RhodoLED or RhodoLED XL lamp). Results from a small study suggest that Ameluz (aminolevulinic acid) might also work with blue light, but more research is needed in this area. Talk with your provider if you have more questions about Ameluz (aminolevulinic acid) and PDT.
              How long does photosensitivity last after Ameluz (aminolevulinic acid)?
              After your provider has applied Ameluz (aminolevulinic acid), the treated skin area will be sensitive to light for about 48 hours (2 days). You should avoid getting exposed to sunlight or bright indoor lights, including tanning beds, examination lamps, or lights that are close to your body. If you need to go outside, make sure to cover the treated area by wearing a wide-brimmed hat. If your skin becomes exposed to light, you'll feel stinging and burning, and notice swelling or redness in the treated area.
              Can I use Ameluz (aminolevulinic acid) if I have porphyria?
              No, people with porphyria (a condition that affects red blood cells) shouldn't use Ameluz (aminolevulinic acid) or other medications containing aminolevulinic acid. Doing so can cause serious light sensitivity reactions and lead to symptoms like burns or rash.
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              What are the risks and warnings for Ameluz (aminolevulinic acid)?

              Ameluz (aminolevulinic acid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

              risk-warning

              Severe allergic reaction

              Though rare, Ameluz (aminolevulinic acid) can cause serious allergic reactions, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). If you experience trouble breathing, swelling of your lips, tongue, or face, or rash after treatment with Ameluz (aminolevulinic acid), get emergency medical help right away.

              risk-warning

              Temporary memory problems

              Some people have reported temporary memory problems after using Ameluz (aminolevulinic acid) with photodynamic therapy (PDT), but this isn't common. If you feel confused or have trouble remembering things after your treatment, contact your provider.

              risk-warning

              Higher sensitivity to light

              • Risk factors: Taking medications that make your skin more sensitive to light

                Ameluz (aminolevulinic acid) makes your skin more sensitive to light. Your risk for skin damage from light exposure is higher if you're taking other medications that make your skin more sensitive to light. After getting treatment with Ameluz (aminolevulinic acid), avoid sunlight, tanning beds, and bright indoor light for 2 days, even if you aren't exposed to light therapy.

                You can protect the treated areas of your skin by wearing a wide-brimmed hat. Doing so can help prevent stinging, burning, irritation, and swelling at the treatment sites on your skin. Keep in mind that wearing sunscreen won't protect your skin from visible light.

                risk-warning

                Damage to eyes and other sensitive areas

                The special lamps used for light therapy after treatment with Ameluz (aminolevulinic acid) can cause eye irritation or injury. Your provider will ask you to wear protective eyewear while you're getting light therapy to protect your eyes. Never stare directly into the lamp while it's on.

                Ameluz (aminolevulinic acid) can also cause swelling of your eyelids, as well as irritation to other sensitive skin areas, such as the nose and mouth. Your provider will take care to not get this medication in your eyes or to other sensitive areas. But if they do on accident, you'll need to rinse the area with water as soon as possible.

                risk-warning

                Risk of bleeding

                • Risk factors: Taking blood thinners | Bleeding problems

                  Ameluz (aminolevulinic acid) hasn't been well-studied in people with bleeding conditions. Let your provider know if you're taking blood-thinning medications (e.g., warfarin (Coumadin)) or if you have a history of bleeding problems. If any of the AK spots have bleeding or broken skin, your provider might not be able to treat you with Ameluz (aminolevulinic acid) until they're healed.

                  dosage

                  Ameluz (aminolevulinic acid) dosage forms

                  Typical dosing for Ameluz (aminolevulinic acid)

                  Ameluz is made up of aminolevulinic acid 10% topical gel.

                  • Adults: Ameluz (aminolevulinic acid) is applied to the sun spots (on the scalp or face only) by a healthcare provider at their clinic. Your provider will cover the treated area and let the medication absorb into the skin for 3 hours. Afterwards, you'll receive photodynamic therapy (PDT) with the BF-RhodoLED or RhodoLED XL lamp for about 10 minutes.

                  If needed, your provider can treat the spots again after 3 months.

                  contraindications-icon

                  Ameluz (aminolevulinic acid) contraindications

                  Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ameluz (aminolevulinic acid) will not be safe for you to take.

                  • Porphyria (a genetic condition where your body has problems making a protein called heme)

                  • Allergies to porphyrins or soybean phosphatidylcholine (a component of soybeans)

                  • Photodermatoses

                  alternatives

                  What are alternatives to Ameluz (aminolevulinic acid)?

                  There are a number of medications that your doctor can prescribe in place of Ameluz (aminolevulinic acid). Compare a few possible alternatives below.
                  Ameluz (aminolevulinic acid)
                  Used for:

                  • Mild-to-moderate actinic keratoses on the face and scalp (in combination with photodynamic therapy)

                  View Prices
                  Levulan Kerastick (aminolevulinic acid)
                  Used for:

                  • Minimally to moderately thick actinic keratoses of the face, scalp, or arms and hands (in combination with photodynamic therapy)

                  View Prices
                  Diclofenac sodium (Solaraze) 3% gel
                  Used for:
                  $40.00 Lowest GoodRx priceView Prices

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                  References

                  Best studies we found

                  American Cancer Society. (2021). Getting photodynamic therapy.

                  Biofrontera Inc. (2023). Ameluz- aminolevulinic acid hydrochloride gel [package insert]. DailyMed.

                  Lehmann, P., et al. (2011). Photodermatoses: Diagnosis and treatment. Deutsches Ärzteblatt International.

                  View All References (4)

                  Malcolm, E. (2020). What are porphyrins and how are they connected to porphyria? Porphyria News.

                  MedlinePlus. (2009). Porphyria.

                  National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Porphyria.

                  Nestor, M. S., et al. (2019). Safety and efficacy of aminolevulinic acid 10% topical gel versus aminolevulinic acid 20% topical solution followed by blue-light photodynamic therapy for the treatment of actinic keratosis on the face and scalp: A randomized, double-blind study. The Journal of Clinical and Aesthetic Dermatology.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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