GNH USA

Europe — EMA

Gliolan

Gliolan (aminolevulinic acid hydrochloride) is a prescription oral powder used for fluorescence‑guided resection of malignant glioma, enhancing tumor visualization during surgery.

Aminolevulinic Acid Hydrochloride

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What is 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.

What is Aminolevulinic Acid Hydrochloride used for?

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.

What are the side effects of Aminolevulinic Acid Hydrochloride?

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.

What precautions apply to Aminolevulinic Acid Hydrochloride?

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.

What does Aminolevulinic Acid Hydrochloride interact with?

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

What is the mechanism of action of Gliolan in brain tumor surgery?+
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.
How is Gliolan administered before a glioma resection?+
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.
Which patients are eligible for fluorescence‑guided surgery with Gliolan?+
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.
What pre‑operative tests are recommended before using Gliolan?+
Baseline liver function tests are recommended, and clinicians should assess for a history of porphyria or photosensitivity conditions before administering the drug.
Can Gliolan be used in pediatric patients?+
Current labeling and clinical data focus on adult use; the safety and efficacy of Gliolan in children have not been established.
What type of lighting is required to visualize fluorescence after Gliolan administration?+
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.
How long does the fluorescence last during surgery?+
Fluorescence typically persists for the duration of the operation, allowing continuous visualization of tumor margins as long as the blue‑light source is applied.
What are common side effects patients may experience after taking Gliolan?+
Common side effects include transient nausea, mild headache, dizziness, temporary skin redness after light exposure, and mild, reversible elevations in liver enzymes.
What serious adverse reactions should clinicians monitor for?+
Serious reactions can include severe photosensitivity with blistering, anaphylactic or severe hypersensitivity responses, and acute liver injury indicated by marked transaminase rise and jaundice.
Should patients avoid sunlight after taking Gliolan?+
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.
Are there any known drug interactions with Gliolan?+
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.
Is Gliolan available over the counter?+
Gliolan is a prescription‑only medication and must be prescribed by a qualified healthcare professional.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Aminolevulinic Acid Hydrochloride
Route
Oral Use
Manufacturer
Photonamic Gmbh & Co. Kg
Origin
EU

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