Patient Medication Information: uses, side effects, how to take - Gleolan
What is Gleolan used for?
Gleolan is used to help visualize certain brain tumours (called malignant glioma) during tumour surgery.
How does Gleolan work?
Gleolan contains a substance called Aminolevulinic Acid. This substance accumulates preferably in tumour cells where it is transformed into another similar substance. If the tumour is then exposed to blue light, this new substance emits a red-violet light. This helps to better see what is normal tissue and what is tumour tissue. This helps the surgeon to remove the tumour while sparing healthy tissue.
What are the ingredients in Gleolan?
Medicinal ingredients: Aminolevulinic Acid Hydrochloride (Aminolevulinic Acid HCl)
Gleolan comes in the following dosage forms:
Powder for oral solution, 1.5 g / vial
Do not use Gleolan if:
- you are allergic to Aminolevulinic Acid or any of the other ingredients in this drug or the container.
- you are allergic to porphyrins (parts of what form red blood cells pigments).
- you have known or suspected acute or chronic types of porphyria. This is a type of inherited or acquired disorders involved in making red blood pigment).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Gleolan. Talk about any health conditions or problems you may have, including if you:
are pregnant, think you are pregnant, or plan to become pregnant
- are breast feeding. It is not known if Gleolan passes into breast milk. Your doctor may tell you to pump and throw away breast milk for a period of 24 hours after you are given Gleolan.
- have or had problems with your kidney
- have or had problems with your liver
- have a heart disease or had heart disease in the past.
Other warnings you should know about:
Gleolan can make your skin more sensitive to light. Reduce your exposure to sunlight or strong
room lights for 48 hours after you are given Gleolan.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Gleolan:
phototoxic drugs (drugs that make your skin more sensitive to the sun) such as:
- certain antibiotics (tetracyclines, sulfonamides, fluoroquinolones)
- antifungals (such as Griseofulvin)
- thiazide diuretics
- diabetes drugs (such as sulfonylureas)
- antipsychotic drugs (such as phenothiazines)
- topical drugs containing Aminolevulinic Acid Hydrochloride
- St. John’s wort
Do not take these for 24 hours before or after you are given Gleolan.
How to take Gleolan:
Gleolan will be prepared and given to you by a trained healthcare professional. Gleolan is a powder that will be first mixed with drinking water before use. Gleolan will be given to you 2-4 hours before anaesthesia (being put to sleep before the surgery).
If your surgery has been re-scheduled within less than 12 hours, your healthcare professional will not need to give you a new dose of Gleolan. If your surgery is delayed more than 12 hours, it should be re-scheduled to the next day or later. Your healthcare professional will give you another dose of Gleolan 2-4 hours before anaesthesia.
Usual dose:
The usual dose is 20 mg ofAminolevulinic Acid Hydrochloride per kilogram body weight. Your healthcare professional will calculate the exact dose you need and the amount of the solution (in mL) you have to drink.
Overdose:
Your healthcare professional will determine the right dose for you. If you have taken more Gleolan than you should, your healthcare professional will decide on any steps needed to avoid any problems. This includes protection from strong light (for example direct sunlight).
If you think you have received too much Gleolan, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Your healthcare professional will give you Gleolan only once at the day of your surgery, 2 – 4 hours before anaesthesia (being put to sleep). If you have not taken Gleolan in this time period, tell your healthcare professional immediately. Your surgery may be delayed until later.
What are possible side effects from using Gleolan?
These are not all the possible side effects you may feel when taking Gleolan. If you experience any side effects not listed here, contact your healthcare professional.
Some of the side effects are related to the surgery, while some of the side effects are related to Gleolan.
- Headache
- decrease of sense of touch
- fever
- chills
- nausea
- vomiting
- diarrhea
- red skin rash that may itch and burn after being exposed to the sun
- hives, skin redness
After you are given Gleolan, you may also have side effects of abnormal blood test results related to your liver.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
Nervous system problems: including:
| √ | ||
Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations. This symptom has only been seen in the week after surgery and is not related to taking Gleolan.. | √ | ||
| UNCOMMON | |||
| Brain edema (brain swelling): headache, nausea, dizziness, lack of coordination | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up). This symptom is related to taking Gleolan. | √ | ||
| Venous thrombosis (clot in a blood vessel): swelling and pain in one part of the body | √ | ||
| UNKNOWN | |||
| Anaphylactic shock (allergic reaction): difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | √ | ||
| Angioedema (swelling of tissue under the skin): difficulty breathing; swollen face, hands and feet, genitals tongue, throat; Swelling of the digestive tract causing diarrhea, nausea or vomiting | √ | ||
| Lactic Acidosis (high level of acid in the blood): nausea, vomiting, fatigue, abdominal pain, unusual muscle pain, dizziness, irregular heartbeat, shortness of breath | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Your healthcare professional will store this medication for you.
Store at room temperature (15°C - 30°C).
Keep out of reach and sight of children.
If you want more information about Gleolan:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.medexus.ca, or by calling 1-877-633-3987.