Europe — EMA
Hexvix
Hexvix (hexaminolevulinate) is a bladder cancer diagnostic agent that highlights malignant cells during cystoscopy using fluorescence imaging.
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What is Hexaminolevulinate?
Hexvix is an intravesical solution containing the active ingredient hexaminolevulinate. It is supplied as a prescription‑only diagnostic agent, formulated for bladder instillation. The product is marketed in the European Union and is used without a specified strength label, relying on a standardized preparation protocol. Hexvix enables clinicians to visualize abnormal urothelial tissue during cystoscopic examination. The fluorescence‑guided approach improves detection of early lesions and supports treatment planning.
What is Hexaminolevulinate used for?
Hexvix is indicated for the photodynamic diagnosis of bladder cancer during cystoscopy, helping to identify non‑muscle invasive lesions.
- Detection of non‑muscle invasive bladder cancer (NMIBC) during white‑light cystoscopy. - Identification of carcinoma in situ that may be missed by standard imaging. - Guidance for targeted biopsy of suspicious urothelial areas. - Assessment of tumor margins after transurethral resection. - Adjunctive use in surveillance cystoscopies to improve recurrence detection.
What are the side effects of Hexaminolevulinate?
Adverse reactions to Hexvix are generally related to the intravesical administration and the photosensitizing properties of the agent.
Common: - Transient bladder irritation or burning sensation. - Mild hematuria or pink urine discoloration. - Temporary urinary urgency or frequency. - Low‑grade fever or chills.
Serious: - Severe allergic reaction (anaphylaxis) with rash, swelling, or respiratory distress. - Persistent bladder inflammation (cystitis) requiring medical intervention. - Photosensitivity reactions in surrounding tissues if light exposure is uncontrolled. - Acute urinary retention.
What precautions apply to Hexaminolevulinate?
Before using Hexvix, clinicians should evaluate patient history and procedural factors to minimize risks associated with intravesical instillation and fluorescence imaging.
- Confirm absence of active urinary tract infection prior to instillation. - Ensure the patient has not received photosensitizing drugs within the past two weeks. - Verify adequate bladder capacity and no recent traumatic catheterization. - Use appropriate protective eyewear for staff during blue‑light illumination. - Monitor the patient for immediate urinary discomfort or allergic signs after administration. - Avoid use in patients with known hypersensitivity to porphyrin derivatives.
What does Hexaminolevulinate interact with?
Hexvix may interact with other substances that affect photosensitivity or bladder physiology; awareness of these interactions helps prevent complications.
Avoid: - Systemic photosensitizers such as porfimer sodium or aminolevulinic acid. - Recent intravesical chemotherapy agents that irritate the bladder lining. - Antifungal or antibacterial agents that alter urothelial metabolism within 48 hours.
Use with caution: - Anticoagulants, because bladder irritation could increase bleeding risk. - Drugs that cause urinary retention, such as anticholinergics. - Immunosuppressive therapy, which may modify inflammatory response to the agent.
Frequently asked questions
What is the purpose of Hexvix in bladder cancer evaluation?+
How is Hexvix administered to patients?+
What type of light is required to visualize Hexvix fluorescence?+
Can Hexvix be used in patients who have recently undergone bladder surgery?+
What are common side effects after Hexvix instillation?+
Is there a risk of allergic reaction with Hexvix?+
Should other photosensitizing drugs be stopped before using Hexvix?+
What precautions are needed for medical staff during the procedure?+
Can Hexvix be used in pregnant or breastfeeding women?+
How does Hexvix differ from standard white‑light cystoscopy?+
Is Hexvix covered by health insurance in the EU?+
What should be done if a patient experiences persistent urinary retention after Hexvix?+
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