Aminolevulinic acid Topical

Aminolevulinic acid is used in combination with photodynamic therapy (PDT; special blue light) to treat actinic keratoses (small crusty or scaly bumps or horns on or under the skin that result from exposure to sunlight and can develop into skin cancer) of the face or scalp. Aminolevulinic acid is in a class of medications called photosensitizing agents. When aminolevulinic acid is activated by light, it damages the cells of actinic keratosis lesions.

Before using aminolevulinic acid,

• tell your doctor and pharmacist if you are allergic to aminolevulinic acid, porphyrins, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; diuretics ('water pills'); griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG); medications for diabetes, mental illness, and nausea; sulfa antibiotics; and tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have porphyria (a condition that causes sensitivity to light). Your doctor will probably tell you not to use aminolevulinic acid.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant during treatment with aminolevulinic acid, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using aminolevulinic acid.
• you should know that aminolevulinic acid will make your skin very sensitive to sunlight (likely to get sunburn). Avoid exposure of treated skin to direct sunlight or bright indoor light (e.g. tanning salons, bright halogen lighting, close task lighting, and high power lighting used in operating rooms or dental offices) before exposure to blue light treatment. Before going outdoors in the sunlight, protect treated skin from the sun by wearing a wide-brimmed hat or other head covering that will shade the treated area or block the sun. Sunscreen will not protect you from sensitivity to sunlight. If you feel burning or stinging of the treated areas or see that they have become red or swollen, be sure that you are keeping the area protected from sunlight or bright light.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Protect skin from sunlight or other strong light for at least 40 hours.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe stinging or burning that lasts longer than 4 weeks.

Common side effects may include:

• redness or swelling of treated skin;
• itching, stinging, tingling, or prickly feeling;
• scaling or crusting of the skin; or
• changes in the color of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

A healthcare provider will apply this medicine directly to the lesions on your face or scalp. You will not be allowed to apply aminolevulinic acid yourself. The face and scalp may need to be treated in separate sessions if you have actinic keratosis on both areas.

Within 14 to 18 hours after aminolevulinic acid is applied, you must return to your doctor's office to receive a special blue light treatment.

After aminolevulinic acid is applied, keep the treated skin dry. Do not wash the skin while you are waiting for the light treatment.

For at least 40 hours after the medicine is applied, you will need to protect your skin from bright light. Sunscreen will not be effective enough to protect you while this medicine is on your skin or scalp. Avoid exposure to both sunlight and bright indoor light. Wear protective clothing and a wide-brimmed hat when you are outdoors. If you feel stinging or burning of the treated skin, reduce your exposure to light.

The blue light has a low intensity and will not heat your skin. However, you may feel tingling, stinging, prickling, or burning of the skin where aminolevulinic acid was applied. This discomfort is usually temporary.

After light treatment you may have some redness, swelling, and scaling of your lesions and the surrounding skin. These symptoms should go away completely within 4 weeks.

Call your doctor if you have severe skin discomfort, or if you have new or worsening skin problems.

If your actinic keratosis lesions do not clear up completely, you may need to receive a second treatment with aminolevulinic acid and blue light treatment. You should allow at least 8 weeks to pass between treatments.

Since this medicine is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you cannot return for the blue light treatment within the recommended 14 to 18 hours after aminolevulinic acid was applied. The timing of this medicine and light treatment is extremely important to the success of your treatment.

You may need to reschedule your light treatment appointment if you cannot receive it at the correct time after aminolevulinic acid was applied.

You will receive aminolevulinic acid in a clinic or doctor's office. A nurse or other caregiver will apply the medicine.

If you are using the aminolevulinic acid solution:

• Blue light illumination treatment must be followed with BLU–U Blue Light Photodynamic Therapy Illuminator in your doctor's office 14 to 18 hours after the application. The blue light treatment lasts approximately 17 minutes.
• Your doctor may want to retreat you after 8 weeks if your skin condition did not completely resolve.
• Call your doctor if you cannot return for the blue light illumination treatment after the aminolevulinic acid application. You should then protect the treated skin from sunlight and prolonged or intense light for at least 40 hours.

If you are using the aminolevulinic acidgel:

• aminolevulinic acid is applied on your lesions and may be applied to the skin around the lesions. Do not get any of the gel in your eyes, nose, mouth, or ears. Rinse it off right away if it does get on these areas.
• After gel application, the area where the gel has been applied will be covered with a light-blocking, occlusive dressing for 3 hours.
• Immediately after removing the dressing and any remaining gel, you will be treated with a red light using the BF-RhodoLED® lamp.
• If the lesions cannot be treated with the BF-RhodoLED® lamp within 3 hours after the gel has been applied, then rinse off the gel with saline and water and protect the lesion sites from sunlight or prolonged or intense light for 2 days.
• Your doctor may want to retreat you after 3 months if your skin condition did not completely resolve.

Your doctor will check your progress closely while you are receiving aminolevulinic acid. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

If your condition does not improve within 3 months , or if it become worse, check with your doctor.

Using Ameluz® with BF-RhodoLED® lamp may cause eye irritation or injury. It may also cause swelling of the eyelids. Tell your doctor right away if you have blurred vision, changes in vision, or red, sore eyes after receiving aminolevulinic acid.

After aminolevulinic acid application, avoid exposure to sunlight or bright indoor light (eg, from examination lamps, operating room lamps, tanning beds, or being close to lights) up until the time of the blue or red light treatment. Wide-brimmed hats or similar head covering can help protect you from sunlight or sources of light. Sunscreens will not protect you from sunlight or sources of light.

Reduce your exposure to light if you experience stinging or burning on the treated areas before blue light treatment.

During the blue light treatment you will experience sensations of tingling, stinging, prickling or burning of the treated skin. These feelings of discomfort should improve at the end of the light treatment.

Following treatment, the actinic keratoses and possibly the surrounding skin will redden and swelling and scaling may also occur. These changes are temporary and should completely resolve by 4 weeks after treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External, as hydrochloride:

Ameluz: 10% (2 g) [contains isopropyl alcohol, phosphatidylcholine, soy, polysorbate 80, propylene glycol, sodium benzoate]

Solution Reconstituted, External, as hydrochloride:

Levulan Kerastick: 20% (1 ea) [contains alcohol, usp, isopropyl alcohol, laureth, polyethylene glycol]

Actinic keratoses:

Gel (Ameluz): Lesion-directed and field-directed topical treatment of mild to moderate actinic keratosis of the face and scalp; to be used in conjunction with photodynamic therapy with narrowband red light illumination (using BF-RhodoLED lamp).

Solution (Levulan Kerastick): Topical treatment of minimally to moderately thick actinic keratoses of the face or scalp; to be used in conjunction with photodynamic therapy with blue light illumination (using BLU-U blue light).

Hypersensitivity to aminolevulinic acid or any component of the formulation; known allergy/hypersensitivity to porphyrins; known porphyria; hypersensitivity to soybean phosphatidylcholine (Ameluz); cutaneous photosensitivity at wavelengths of 400 to 450 nm (Levulan Kerastick); photodermatoses (Ameluz)