Ameluz

What is Ameluz used for?

• Ameluz is used to treat a precancerous skin problem called actinic keratosis.

Before taking Ameluz, tell your doctor:

• If you are allergic to porphyrins.
• If you are allergic to Ameluz; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If your skin is sensitive to light.
• If you have porphyria.
• If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ameluz with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ameluz?

• Tell all of your health care providers that you take Ameluz. This includes your doctors, nurses, pharmacists, and dentists.
• The treated area may be more sensitive to light. Light may cause a burning or stinging feeling. 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. Wear the proper covering like a wide-brimmed hat, long sleeve shirt, or gloves to protect the treated skin from light. 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 Ameluz is swallowed, call a doctor or poison control center right away.
• People using Ameluz may get skin reactions where Ameluz is used or around the area. These reactions may include burning, crusting, dryness, flaking, itching, oozing, redness, scabbing, scaling, stinging, 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 Ameluz 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.

How is Ameluz best taken?

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

• This medicine is used with light therapy.
• Your doctor or other healthcare provider 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.
• Do not wash the treated part before you have the light therapy.
• 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 Ameluz has been put on, talk with your doctor. Avoid bright light for as long as you have been told by your doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Ameluz that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Bleeding where Ameluz is used.
• Eyelid swelling.
• Change in color of skin where drug is used.
• Memory problems may rarely happen with the use of Ameluz and light therapy. Most of the time, these memory problems go back to normal after a short amount of time. Call your doctor right away if you have memory problems or loss, or if you feel confused.

What are some other side effects of Ameluz?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Chills.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Ameluz?

• If you need to store Ameluz at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer information use and disclaimer

• 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 all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Ameluz, 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.