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 a prescription‑only diagnostic agent that contains the active ingredient aminolevulinic acid hydrochloride. It is supplied as an oral formulation, though specific strength and dosage form are not detailed. Classified as a photosensitizer prodrug, Gliolan is used in the European market to aid intra‑operative visualization of malignant brain tumors through fluorescence guidance after oral administration before surgery and to support surgical decision‑making in the operating room.

Manufacturer / TM Owner

Photonamic Gmbh & Co. Kg

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Indications & Clinical Uses

Gliolan is indicated for fluorescence‑guided resection of malignant gliomas and other brain tumors during neurosurgical procedures.

  • Oral administration of Gliolan prior to craniotomy to enable tumor fluorescence under blue light.
  • Use in conjunction with a surgical microscope equipped with a fluorescence filter to differentiate tumor tissue from normal brain.
  • Application in intra‑operative mapping to assist surgeons in achieving maximal safe resection while preserving functional areas.
  • Integration into multimodal imaging protocols, complementing MRI or PET data for surgical planning.
  • Potential use in research settings to evaluate fluorescence‑guided techniques for other solid tumors.

Side Effects

The safety profile of Gliolan reflects the pharmacologic activity of its metabolite, protoporphyrin IX, and the procedure‑related context of its use.

Common

  • Transient skin photosensitivity, manifesting as mild redness or itching when exposed to bright light.
  • Nausea or mild gastrointestinal discomfort following oral intake.
  • Headache or dizziness during the peri‑operative period.
  • Temporary visual disturbances, such as altered color perception under the fluorescence filter.
  • Mild fatigue or somnolence reported in the hours after administration.

Serious

  • Severe photosensitivity reactions, including blistering or burns on exposed skin.
  • Allergic reactions ranging from urticaria to anaphylaxis, though rare.
  • Elevated liver enzymes indicating hepatic stress in susceptible patients.
  • Seizure activity potentially precipitated by fluorescence illumination in patients with pre‑existing epilepsy.

Precautions & Warnings

When using Gliolan, clinicians should observe specific precautions to minimize risks associated with photosensitivity and the intra‑operative environment.

  • Administer the drug in a dimly lit environment and advise patients to avoid direct sunlight for 24 hours after dosing.
  • Confirm the availability of a fluorescence‑compatible surgical microscope before the procedure.
  • Assess liver function prior to administration, as hepatic impairment may affect metabolite accumulation.
  • Screen for a history of photosensitivity disorders or porphyria before prescribing.
  • Monitor patients for allergic reactions during and after infusion, with emergency equipment on hand.
  • Document the timing of oral dose relative to surgical start to ensure optimal fluorescence intensity.

Avoid Interactions

Gliolan may interact with agents that influence photosensitivity, hepatic metabolism, or the optical environment of the operating room.

Avoid

  • Avoid concurrent use of strong photosensitizing drugs such as tetracyclines, sulfonamides, or psoralen derivatives.
  • Do not combine with other fluorescent dyes that emit at similar wavelengths, as this can obscure tumor visualization.

Use with caution

  • Use caution when administering drugs metabolized by the hepatic cytochrome P450 system, including certain anticonvulsants.
  • Caution is advised with agents that may lower seizure threshold, especially in patients with epilepsy.
  • Exercise care when using anesthetic agents that affect cerebral blood flow, as this may alter fluorescence intensity.
  • Monitor for potential additive effects with other agents that cause skin photosensitivity, such as retinoids.

Frequently Asked Questions

Gliolan is metabolized in tumor cells to protoporphyrin IX, which emits red fluorescence when illuminated with blue light, allowing surgeons to see cancerous tissue during the operation.

The drug is given orally as a single dose a few hours prior to the start of surgery, providing sufficient time for tumor uptake and fluorescence development.

Gliolan is approved for malignant gliomas and other high‑grade brain tumors that accumulate the prodrug, enabling fluorescence‑guided resection.

A surgical microscope equipped with a blue‑light excitation source and a filter to capture the red fluorescence emitted by protoporphyrin IX is needed.

Clinical practice typically schedules the oral dose 2 to 4 hours before the planned incision to achieve optimal tumor fluorescence.

No specific dietary restrictions are required, but patients should follow any fasting instructions given by the surgical team.

Common side effects include mild skin photosensitivity, nausea, headache, dizziness, and temporary visual disturbances under the fluorescence filter.

Serious reactions can include severe photosensitivity burns, allergic responses such as anaphylaxis, elevated liver enzymes, and seizures in susceptible individuals.

Patients with significant hepatic impairment should be evaluated carefully, as liver function influences the conversion of the prodrug to its fluorescent metabolite.

The safety of Gliolan in pregnancy and lactation has not been established; it should be used only if the potential benefit justifies the potential risk.

Gliolan is a specific formulation of aminolevulinic acid hydrochloride approved in the EU, whereas 5‑ALA is a broader term for similar compounds used in other regions; both rely on protoporphyrin IX fluorescence but may differ in dosing and regulatory status.

Patients should avoid direct sunlight and bright indoor lighting for at least 24 hours, wear protective clothing if exposure is unavoidable, and report any skin reactions to their healthcare provider.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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