Better Visualization for a Greater Extent of Resection

Traditional White Light

When illuminating the surgical field under white light, it may be difficult to distinguish the tumor from surrounding healthy tissue.

Blue Light

With Gleolan administered, when the surgical field is illuminated with white light using a blue filter, the high-grade glioma fluoresces red-violet, making it easier to identify.

Phase III Study

  •  In a clinical study, patients with suspected malignant glioma amenable to complete resection of contrast-enhancing tumor were randomly assigned to 20 mg/kg Gleolan for fluorescence-guided resection or to conventional microsurgery with white light (FAS n=176 and n=173 respectively)1
  • A primary endpoint was the number of patients without contrast-enhancing tumor on early MRI (within 72 hours after surgery for resection)2
  •  Fluorescence may also be seen in areas of inflammation or metastases from other tumor types3

EOR, extent of resection; MRI, magnetic resonance imaging

  1. NXDC Briefing Package, Medical Imaging Drugs Advisory Committee, May 10,2017.
  2. Stummer W, et al. Lancet Oncol. 2006;7:392-401.
  3. Gleolan [(aminolevulinic acid HCl) for oral solution] Prescribing Information.

Why Use Gleolan?

  • Indicated for use in suspected WHO Grade III and IV glioma1-7
  • Surgeons using fluorescence-guided surgery with Gleolan demonstrated significant improvement in extent of resection vs white light1
  • Facilitates real-time visualization of suspected WHO Grade III and IV glioma2
  • Not limited by brain shift3
  • >95% Positive Predictive Value (PPV) for identification of malignant tissue4
  • NPV varies based on sampling location2
  • Improved visualization, beyond that identified by preoperative MRI5
  • Compatible with other technologies used during resection6
  • Rates of long-term neurologic complications in procedures that used Gleolan fluorescence-guided surgery vs white light are similar7

Citations / References

  1. Gleolan [(aminolevulinic acid HCl) for oral solution] Prescribing Information.
  2. Díez Valle R, et al. J Neurooncol. 2011;102:105-113.
  3. Widhalm G. Clin Neuropathol. 2014;33:260-278
  4. Data on file. NX Development Corp.
  5. Stummer W, et al. Neurosurgery. 2014;74:310-320.
  6. Schucht P, et al. Neurosurgery. 2012;71:927-936.
  7. Stummer W, et al. Lancet Oncol. 2006;7:392-401.

Adverse Reactions

In 5 clinical trials:

  • Adverse reactions that occurred in >1% of patients in the week following surgery were: pyrexia, hypotension, nausea, and vomiting
  • Adverse reactions occurring in the first 6 weeks after surgery in <1% of patients were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea
  • Neurologic 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%)
  • Elevated liver enzymes (ALT and GGT) occurred in 15.8% and 11.6%, respectively) within first week after surgery which remained elevated in some patients 6 weeks after surgery

Due to 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 oral administration of Gleolan.

Please see Full Prescribing Information for additional important safety information.

 

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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