Pronunciation:

a-mee-noe-lev-ue-LIN-ik AS-id

Brand Names:

• Gleolan

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Photosensitizing Agent

Uses of This Medicine:

Aminolevulinic acid is used to help your doctor see an image of a malignant (cancer) tissue during surgery in patients with glioma (tumor in the brain or spine). It is an optical imaging agent.

This medicine is to be given only by or under the supervision of a doctor.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aminolevulinic acid in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aminolevulinic acid in the elderly. However, some elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this diagnostic test with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetazolamide
• Acetohexamide
• Balofloxacin
• Bendroflumethiazide
• Benzthiazide
• Besifloxacin
• Chlorothiazide
• Chlorpromazine
• Chlorpropamide
• Chlortetracycline
• Chlorthalidone
• Cinoxacin
• Ciprofloxacin
• Clopamide
• Demeclocycline
• Diazoxide
• Dixyrazine
• Doxycycline
• Enoxacin
• Flumequine
• Fluphenazine
• Gatifloxacin
• Gemifloxacin
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Griseofulvin
• Hydrochlorothiazide
• Hydroflumethiazide
• Indapamide
• Levofloxacin
• Lomefloxacin
• Lymecycline
• Mafenide
• Meclocycline
• Methacycline
• Methdilazine
• Methotrimeprazine
• Methyclothiazide
• Metolazone
• Metopimazine
• Minocycline
• Moxifloxacin
• Nadifloxacin
• Nalidixic Acid
• Norfloxacin
• Ofloxacin
• Oxolinic Acid
• Oxytetracycline
• Pazufloxacin
• Pefloxacin
• Perazine
• Periciazine
• Perphenazine
• Pipemidic Acid
• Pipotiazine
• Polythiazide
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Prulifloxacin
• Rolitetracycline
• Rosoxacin
• Rufloxacin
• Silver Sulfadiazine
• Sparfloxacin
• St John's Wort
• Sulfacetamide
• Sulfacytine
• Sulfadiazine
• Sulfadoxine
• Sulfamethizole
• Sulfamethoxazole
• Sulfapyridine
• Sulfasalazine
• Sulfisoxazole
• Tetracycline
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tolazamide
• Tolbutamide
• Trichlormethiazide
• Trifluoperazine
• Triflupromazine
• Xipamide
• Zonisamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to porphyrins or
• Porphyria, acute or chronic—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. It is given by mouth before surgery.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause photosensitivity (increased sensitivity to sunlight). Avoid exposure to sunlight or room lights for 48 hours after surgery.

If you are using medicine that can cause photosensitivity (eg, griseofulvin, St. John’s wort, diuretic, phenothiazine, quinolone, sulfa drug, sulfonylurea, tetracycline, or topical preparations containing aminolevulinic acid), do not take it 24 hours before and after receiving aminolevulinic acid.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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 or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Blindness over half the field of vision

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

inability to move the legs or arms

paralysis of one side of the body

partial or slight paralysis

problems with movement, walking, or speech

seizure

sweating

unusual tiredness or weakness

Rare

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, scaly skin

headache

increased sensitivity of the skin to sunlight

redness or other discoloration of the skin

severe sunburn

skin rash

swelling

vomiting

Incidence not known

Cough

difficulty swallowing

dizziness

drowsiness

fast heartbeat

hives or welts

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

muscle tremors

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

rapid, deep breathing

restlessness

shakiness and unsteady walk

stomach cramps

tightness in the chest

unsteadiness, trembling, or other problems with muscle control or coordination

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blue lips, fingernails, or skin

difficult or troubled breathing

irregular, fast, slow, or shallow breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Fever

nausea

Rare

Chills

diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.