About Gleolan™

What is Gleolan™?

Gleolan is known as an “optical imaging agent” that is taken by patients before surgery to help neurosurgeons see certain brain tumors, known as “high-grade gliomas.”

Gleolan has been used in 40 countries for over 60,000 patients.

How Does Gleolan™ Work?

Neurosurgeons have several tools that are helpful for locating the tumor during surgery; these tools provide information that allows for removal of as much tumor tissue as possible. For your surgery, your neurosurgeon may recommend the use of Gleolan.

Gleolan is an oral solution, which you will drink 3 hours (between 2 to 4 hours) before you receive anesthesia for your surgery. It contains aminolevulinic acid hydrochloride (ALA HCl). During the surgery, your neurosurgeon will view the brain through special blue light filters on the surgical microscope. Under this blue light, Gleolan helps the tumor “fluoresce” or glow a red-violet color.

Since non-cancerous brain cells should not glow when using the blue light filters, the neurosurgeon may be able to better distinguish the tumor from normal tissue. This may allow the neurosurgeon to remove more of the tumor tissue, however errors may occur with the use of Gleolan. Sometimes brain tumor cells may fluoresce even if they are not cancerous, or those that are cancerous may not fluoresce. Also, cancer cells from other tumors or areas of swelling may fluoresce.

 

Important Safety Information

Contraindications

Do not use Gleolan in patients with:

  • hypersensitivity to aminolevulinic acid (ALA) or porphyrins
  • acute or chronic types of porphyria

Warnings and Precautions

Due to the risk of phototoxic reactions, do not administer phototoxic drugs 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. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma. Fluorescence may be seen in areas of inflammation or metastases from other tumor types.

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.

Adverse Reactions

Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.

Nervous system disorders occurred in 29% of patients within the first week after surgery and events occurring in >1% of patients included: aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in <1% of patients in the first 6 weeks after surgery. In a randomized clinical trial, the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar.

Worsening of >2 Common Toxicity Criteria grades in alanine aminotransferase and gamma-glutamyl transferase occurred in 15.8% and 11.6% of patients, respectively, within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal for each parameter. At 6 weeks, these measurements remained elevated in 2.9% and 7.5% of patients, respectively. There were no cases of liver failure.

Drug-Drug Interactions

See information under Warnings and Precautions regarding phototoxic reactions.

Please see Full Prescribing Information

For medical inquires, please fill out our Medical Information Request Form.

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Important Safety Information

Contraindications

Do not use Gleolan in patients with:

  • hypersensitivity to aminolevulinic acid (ALA) or porphyrins
  • acute or chronic types of porphyria

Warnings and Precautions

Due to the risk of phototoxic reactions, do not administer phototoxic drugs 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. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma. Fluorescence may be seen in areas of inflammation or metastases from other tumor types.

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.

Adverse Reactions

Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.

Nervous system disorders occurred in 29% of patients within the first week after surgery and events occurring in >1% of patients included: aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in <1% of patients in the first 6 weeks after surgery. In a randomized clinical trial, the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar.

Worsening of >2 Common Toxicity Criteria grades in alanine aminotransferase and gamma-glutamyl transferase occurred in 15.8% and 11.6% of patients, respectively, within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal for each parameter. At 6 weeks, these measurements remained elevated in 2.9% and 7.5% of patients, respectively. There were no cases of liver failure.

Drug-Drug Interactions

See information under Warnings and Precautions regarding phototoxic reactions.

Please see Full Prescribing Information

For medical inquires, please fill out our Medical Information Request Form.

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