Ameluz

Included as part of the PRECAUTIONS section.

Mechanism of Action

Aminolevulinic acid is a precursor of photoactive porphyrins, which accumulate in the skin lesions where the product has been applied and are subsequently illuminated with a photodynamic lamp

When exposed to the light, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent on the simultaneous presence of oxygen, which as a result generates a singlet oxygen; the singlet oxygen can then react to form superoxide and hydroxyl radicals

Absorption

Plasma concentration: After occlusion for 3 hr, up to 2.5-fold increase of aminolevulinic acid plasma concentrations observed

Peak plasma time: 3 hr

Peak plasma concentration: 27.19 ng/mL

AUC: 142.83 mg·h/mL

Aminolevulinic acid causes skin cells to become more sensitive to certain types of light. Skin cells treated with aminolevulinic acid will die and slough off after being exposed to a special light treatment.

Aminolevulinic acid is used to treat actinic keratosis (warty overgrowths of skin) on the face and scalp. This medicine is used together with a special light treatment, also called photodynamic therapy.

Aminolevulinic acid may also be used for purposes not listed in this medication guide.

Avoid exposure to sunlight or bright indoor light for at least 40 hours after this medicine is applied to your skin or scalp.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• The treated area may be more sensitive to light. Protect the treated area and skin around it from sun, sunlamps, bright indoor lights, and tanning beds after Ameluz is put on and for as long as you have been told by your doctor. Sunscreens will not help.
• Do not use sunscreen or other drugs on affected part.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• People using Ameluz may get skin reactions where this medicine is used or around the area. These reactions may include redness, scaling, or swelling. Most of the time, these reactions will go away within a few weeks after using Ameluz. Talk with the doctor.
• Call your doctor right away if you have a skin reaction that bothers you or if the reaction makes it hard to keep putting this medicine on. Call your doctor right away if you have a skin reaction that causes problems with daily living.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ameluz while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is used with light therapy.
• Your doctor will put on the skin.
• Keep out of your mouth, nose, and eyes (may burn).
• If you get Ameluz in any of these areas, rinse well with water.
• You will need to protect your eyes during the light therapy. Follow what your doctor has told you.
• If you cannot have the light therapy after this medicine has been put on, talk with your doctor. Avoid bright light for as long as you have been told by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Ameluz or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ameluz. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Animal studies have not shown reproductive toxicity. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be given to a pregnant woman only if clearly needed. US FDA pregnancy category: C

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments:The effects in the nursing infant are unknown.