Gleolan

What is Gleolan?

• Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent used during surgery to help find certain types of brain tumors.

Aminolevulinic acid

What are the uses of this medicine?

• Gleolan (aminolevulinic acid hydrochloride) is used in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

How does this medicine work?

• When Gleolan is taken up by cancer cells and then exposed to certain types of light, it becomes active and may make the cancer cells easier to see. Gleolan contains the active ingredient aminolevulinic acid hydrochloride.
• It is a type of imaging agent and a type of photosensitizing agent.
• Exogenous administration of ALA leads to accumulation of the ALA metabolite PpIX in tumor cells.
• The reason for the accumulation of PpIX in neoplastic brain tissue is not known.
• During glioma surgery, Gleolan is used with an operating microscope adapted with a blue emitting light source (power density 40-80 mW/cm2) and filters for excitation light of wavelength 375 to 440 nm, and observation at wavelengths of 620 to 710 nm.
• This allows tumor tissue to be visualized as red fluorescence.
• Tissue lacking sufficient PpIX concentrations appears blue.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to the aminolevulinic acid (ALA) or porphyrins.
• Acute or chronic types of porphyria, due to potential ineffectiveness of the drug in these patients.

What drug interactions can this medicine cause?

• Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.

Is this medicine FDA approved?

• The US FDA approved aminolevulinic acid hydrochloride (ALA HCL) for this use in 2017.

How should this medicine be used?

Recommended dosage:

• Recommended reconstituted oral dose of Gleolan is 20 mg/kg.

Administration:

• For oral use only.
• Administer Gleolan to patient orally 3 hours (range 2 to 4 hours) before anesthesia.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As oral solution:

• 1,500 mg aminolevulinic acid hydrochloride lyophilized powder, equivalent to 1,170 mg aminolevulinic acid per vial.
• The reconstituted aminolevulinic acid hydrochloride solution contains 30 mg per mL and is clear and colorless to slightly yellowish in color.

This medicine is available in fallowing brand namesː

• GLEOLAN

What side effects can this medication cause?

The most common side effects of this medicine include: Adverse reactions occurring in patients in the week following surgery:

• pyrexia
• hypotension
• nausea
• vomiting
• Elevated liver enzymes

Adverse reactions occurring in patients in the first 6 weeks after surgery were:

• chills
• photosensitivity reaction
• solar dermatitis
• hypotension
• abnormal liver function test
• diarrhea

Neurologic events related to the surgical procedure were:

• aphasia
• hemiparesis
• hemianopia
• headache
• seizure
• hemiplegia
• monoparesis
• hypoesthesia
• brain edema

What special precautions should I follow?

• Due to the risk of phototoxic reactions, do not administer phototoxic drugs (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.
• Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.
• Errors may occur with the use of Gleolan for intraoperative visualization of malignant glioma, including false negatives and false positives
• Hypersensitivity reactions, including serious hypersensitivity reactions have occurred; these reactions include anaphylactic shock, swelling, and urticaria. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.
• Advise patients that they may experience elevated liver enzymes (ALT and GGT) within the first week after surgery. This elevation may persist after 6 weeks.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory insufficiency
• erythema

Management of overdosage:

• In the event of overdose, supportive measures should be provided as necessary, including protection from strong light sources.

Can this medicine be used in pregnancy?

• There are no available human data on Gleolan in pregnant women to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Gleolan in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: aminolevulinic acid HCl
• Inactive ingredients:none

Who manufactures and distributes this medicine?

Distributed by:

• NX Development Corp.
• 870 Corporate Dr., Suite 403
• Lexington, KY

What should I know about storage and disposal of this medication?

• Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F).

• Dailymed label info on Gleolan
• FDA Gleolan

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