Product image of Gliolan (Aminolevulinic Acid Hydrochloride) supplied by GNH India

Gliolan

Active Ingredient:
Aminolevulinic Acid Hydrochloride
Origin:
EU

Gliolan (Aminolevulinic Acid Hydrochloride)

Gliolan is an oral powder for solution containing the active ingredient aminolevulinic acid hydrochloride; the specific strength is not disclosed. It is a prescription‑only prodrug and photosensitizer marketed in the European Union for use in fluorescence‑guided surgery. After oral administration, the compound is metabolized to protoporphyrin IX, which accumulates in tumor cells of malignant gliomas and emits fluorescence under blue light, aiding neurosurgeons during resection in patients.

Manufacturer / TM Owner

Photonamic Gmbh & Co. Kg

1
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Indications & Clinical Uses

Gliolan is indicated for fluorescence‑guided resection of malignant glioma during neurosurgical procedures.

  • Enhances intra‑operative visualization of tumor tissue under blue‑light excitation.
  • Assists surgeons in distinguishing tumor margins from surrounding healthy brain tissue.
  • Supports maximal safe resection while preserving functional cortex.
  • Can be combined with standard imaging modalities such as MRI or neuronavigation for comprehensive surgical planning.
  • Used in adult patients with suspected or confirmed high‑grade glioma.

Side Effects

Adverse reactions reported with Gliolan are generally related to its photosensitizing properties and to systemic exposure to the prodrug.

Common

  • Transient nausea or vomiting after oral intake.
  • Mild headache or dizziness during the procedure.
  • Temporary skin photosensitivity resulting in mild erythema when exposed to strong light.
  • Elevated liver enzymes that resolve without intervention.

Serious

  • Severe photosensitivity leading to blistering or ulceration of exposed skin.
  • Anaphylactic or severe hypersensitivity reactions, including rash, bronchospasm, or hypotension.
  • Acute hepatic injury manifested by marked transaminase elevation and jaundice.

Precautions & Warnings

When prescribing Gliolan, clinicians should evaluate patient-specific factors and follow safety measures to minimize risks.

  • Confirm diagnosis of malignant glioma and suitability for fluorescence‑guided surgery.
  • Perform baseline liver function tests; avoid use in patients with severe hepatic impairment.
  • Advise patients to avoid direct sunlight and intense indoor lighting for 24‑48 hours after dosing.
  • Ensure adequate hydration to reduce the risk of renal concentration of the drug.
  • Review any history of photosensitivity disorders or porphyria before administration.
  • Monitor for signs of allergic reaction during and after infusion.
  • Use protective eye coverings during illumination to prevent ocular phototoxicity.

Avoid Interactions

Gliolan may interact with other medications or substances that affect photosensitivity, hepatic metabolism, or porphyrin pathways.

Avoid

  • Concomitant use of other photosensitizing agents such as tetracyclines, sulfonamides, or psoralen derivatives.
  • Strong CYP450 inducers that could reduce aminolevulinic acid exposure (e.g., rifampin, carbamazepine).
  • Medications known to precipitate porphyria attacks, including certain antiepileptics.
  • High‑dose vitamin A supplements, which may increase photosensitivity.

Use with caution

  • Anticoagulants, because intra‑operative bleeding may be influenced by surgical visualization.
  • Drugs affecting liver function (e.g., acetaminophen overdose) that could alter drug metabolism.
  • Anesthetic agents that may mask early signs of hypersensitivity.
  • Diuretics that may affect renal clearance of metabolites.

Frequently Asked Questions

Gliolan is a prodrug that is converted inside cells to protoporphyrin IX, which preferentially accumulates in malignant glioma cells and fluoresces under blue light, helping surgeons differentiate tumor tissue from normal brain.

Gliolan is supplied as an oral powder that is dissolved in water to create a solution, which the patient drinks a few hours prior to surgery according to the prescribing information.

Adult patients with a confirmed or suspected high‑grade malignant glioma who are scheduled for surgical resection and have no contraindicating liver or photosensitivity disorders may be considered.

Baseline liver function tests are recommended, and clinicians should assess for a history of porphyria or photosensitivity conditions before administering the drug.

Current labeling and clinical data focus on adult use; the safety and efficacy of Gliolan in children have not been established.

A surgical microscope equipped with a blue‑light excitation source (approximately 400–410 nm) is used to induce fluorescence of protoporphyrin IX in tumor tissue.

Fluorescence typically persists for the duration of the operation, allowing continuous visualization of tumor margins as long as the blue‑light source is applied.

Common side effects include transient nausea, mild headache, dizziness, temporary skin redness after light exposure, and mild, reversible elevations in liver enzymes.

Serious reactions can include severe photosensitivity with blistering, anaphylactic or severe hypersensitivity responses, and acute liver injury indicated by marked transaminase rise and jaundice.

Yes, patients are advised to avoid direct sunlight and intense indoor lighting for at least 24–48 hours after dosing to reduce the risk of phototoxic skin reactions.

Gliolan should be avoided with other photosensitizing drugs, strong CYP450 inducers, and medications that can trigger porphyria; caution is advised when used with anticoagulants, liver‑affecting agents, anesthetics, and certain diuretics.

Gliolan is a prescription‑only medication and must be prescribed by a qualified healthcare professional.

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