Hexvix (Hexaminolevulinate)

Hexvix is indicated for photodynamic diagnosis of bladder cancer during cystoscopic examination, helping clinicians visualize malignant tissue that may be missed under white light.

• Detection of carcinoma in situ (CIS) of the bladder, including flat lesions not easily seen with conventional cystoscopy.
• Identification of papillary urothelial tumors, both low‑grade and high‑grade, by fluorescence under blue light.
• Adjunct to standard white‑light cystoscopy, increasing overall lesion detection rate and diagnostic confidence.
• Assessment of tumor recurrence after prior intravesical therapy or surgical resection.
• Guidance for targeted biopsy or transurethral resection during the same procedure, reducing missed pathology.

• Hexvix contains hexaminolevulinate, a prodrug that enters urothelial cells and is metabolized in the heme biosynthetic pathway to protoporphyrin IX. The accumulated protoporphyrin IX preferentially builds up in malignant cells because of altered enzymatic activity, and when illuminated with blue light (≈400 nm) it emits red fluorescence. This selective fluorescence enables clinicians to distinguish cancerous tissue from normal bladder mucosa during cystoscopy.

Adverse reactions to Hexvix are generally related to the intravesical administration procedure and the photosensitizing properties of the drug.

Common

• Mild bladder irritation or burning sensation during or shortly after instillation.
• Transient hematuria (blood in urine) that resolves without intervention.
• Urinary urgency or frequency lasting a few hours.
• Low‑grade fever or chills within 24 hours.
• Nausea or mild headache.
• Mild dysuria (painful urination) during the first day after treatment.

Serious

• Severe allergic reaction (anaphylaxis) presenting with rash, swelling, or respiratory distress.
• Persistent or worsening hematuria requiring medical evaluation.
• Acute urinary retention due to bladder edema.
• Photosensitivity reactions in adjacent skin if exposed to strong light sources.
• Severe bladder spasm causing intense pelvic pain.

When using Hexvix, clinicians should follow specific precautions to minimize risks associated with the diagnostic procedure and the photosensitizer.

• Ensure proper bladder emptying and catheter placement before instillation to avoid leakage.
• Use the recommended concentration (85 mg/50 mL) and volume; do not dilute or concentrate the solution.
• Perform the instillation under sterile conditions and limit exposure time to the manufacturer’s specified duration.
• Advise patients to avoid direct exposure of the treated bladder area to strong light sources for at least 24 hours after the procedure.
• Monitor patients for signs of allergic reaction during and after administration, and be prepared to manage anaphylaxis.

Hexvix may interact with other agents or clinical conditions that affect photosensitivity or bladder physiology.

Avoid

• Concurrent use of systemic photosensitizing drugs (e.g., porfimer sodium, aminolevulinic acid) that could amplify fluorescence and increase risk of skin reactions.
• Exposure to intense ultraviolet or blue‑light sources (phototherapy, laser treatments) within 24 hours after instillation.

Use with caution

• Intravesical chemotherapy agents administered shortly before or after Hexvix, as they may alter bladder mucosa integrity.
• Anticoagulant therapy that could increase the likelihood of hematuria during the procedure.
• Patients with severe renal impairment, where altered drug clearance may affect safety.
• Use in pregnant or breastfeeding women only if the potential benefit justifies the potential risk.