Gleolan

Gleolan is taken before surgery to remove a glioma, which is a type of tumor found in the brain or spinal cord.

Taking Gleolan causes a specific substance to accumulate in your tumor tissue. This helps the tissue be more visible through a special light scope used during surgery to remove the tumor.

Gleolan may also be used for other reasons not mentioned in this medication guide.

For 48 hours after taking Gleolan, you must protect your skin from light, including sunlight and bright indoor light.

You should not use Gleolan if you are allergic to Gleolan or porphyrins, or if you have:

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Tell your doctor if you have ever had liver or kidney disease.

Tell your doctor if you are pregnant.

Do not breastfeed within 24 hours after using Gleolan. If you use a breast pump during this time, throw out the milk and do not feed it to your baby.

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

Your caregivers will monitor you closely to ensure you do not have an allergic reaction and to treat one if it happens.

Many side effects can happen up to 6 weeks after you took Gleolan. Call your doctor immediately if you have:

• a light-headed feeling, like you might pass out;
• skin redness or swelling, raised red areas;
• skin rash, itching, or blistering;
• a seizure;
• chills; or
• trouble speaking or understanding what is said to you.

Common side effects of Gleolan may include:

• nausea, vomiting, diarrhea; or
• abnormal liver function tests (for up to 6 weeks after taking Gleolan).

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.

Gleolan is usually given about 3 hours before surgery. A healthcare provider will prepare and give you this medicine.

For 48 hours after taking Gleolan, you will need to protect your skin from bright light. 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.

Gleolan is given as a single dose and does not require a daily dosing schedule.

In a medical setting, an overdose would be treated quickly.

Avoid exposure to sunlight or bright indoor light for 48 hours after taking Gleolan.

• Wear a hat and clothing that covers your skin.

Tell your doctor about all your other medicines. Some medicines can make you more sensitive to bright light and should be avoided within 24 hours before or after you take Gleolan. This includes:

• St. John's wort;
• an antifungal medicine;
• an antibiotic or sulfa medicine;
• a diuretic or "water pill";
• topical medicine containing Gleolan;
• antipsychotic medicine; or
• an oral diabetes medicine.

This list is not complete. Other drugs may affect Gleolan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.