Hexvix (Hexaminolevulinate)

Hexvix is indicated for the detection of non‑muscle invasive bladder cancer during cystoscopic procedures.

• Enhances visualization of carcinoma in situ and papillary tumors under blue light.
• Used as an adjunct to standard white‑light cystoscopy to improve lesion detection rates.
• Applied intravesically before cystoscopy, typically 1 hour prior to examination.
• Helps differentiate malignant tissue from benign inflammation or scar tissue.
• Supports clinical decision‑making regarding resection or biopsy of suspicious areas.
• Facilitates targeted sampling, potentially reducing the number of unnecessary biopsies.
• Compatible with most commercially available blue‑light cystoscopy systems.

• Hexvix contains hexaminolevulinate, a prodrug that preferentially accumulates in urothelial cancer cells after intravesical administration. Inside the cells, hexaminolevulinate is converted by the heme biosynthetic pathway into protoporphyrin IX, a fluorescent porphyrin. When the bladder is illuminated with blue light (≈ 405 nm), protoporphyrin IX emits red‑orange fluorescence, allowing clinicians to effectively distinguish malignant tissue from normal urothelium in real time during cystoscopy.

Adverse reactions associated with Hexvix are generally related to the intravesical administration and the photosensitizing properties of hexaminolevulinate.

Common

• Mild bladder discomfort or urgency during or after instillation.
• Transient hematuria or pink urine discoloration.
• Temporary burning sensation in the urethra.
• Light sensitivity of the bladder mucosa causing mild erythema.
• Mild abdominal cramping during instillation.
• Transient increase in urinary frequency.
• Mild nausea reported in a minority of patients.
• Temporary dysuria (painful urination).

Serious

• Severe allergic reaction, including anaphylaxis.
• Persistent bladder irritation leading to cystitis.
• Prolonged photosensitivity causing tissue damage if exposed to intense light.
• Severe bladder ulceration requiring medical intervention.
• Vision disturbances if systemic photosensitization occurs.
• Life‑threatening systemic reaction with hypotension.

Before using Hexvix, clinicians should evaluate patient history and follow specific safety measures to minimize risks.

• Confirm no active urinary tract infection before instillation.
• Ensure patient has no known hypersensitivity to hexaminolevulinate or related porphyrins.
• Perform the procedure using approved blue‑light cystoscopy equipment.
• Advise patients to avoid intense bladder illumination for several hours after use.
• Monitor for bladder irritation, hematuria, or allergic reactions during and after the exam.
• Use caution in severe renal impairment, as drug clearance may be altered.
• Record any adverse events in the patient’s chart.

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

Avoid

• Concurrent use of systemic photosensitizing drugs (e.g., porfimer sodium, aminolevulinic acid) that could amplify fluorescence reactions.
• Exposure to strong ultraviolet or blue light sources immediately after instillation.
• Intravesical administration of other chemotherapeutic agents within 24 hours of Hexvix.

Use with caution

• Patients receiving anticoagulants, as bladder irritation may increase bleeding risk.
• Individuals with severe hepatic impairment, which could affect metabolism of porphyrin precursors.
• Use in pediatric patients only when the benefit outweighs potential risks.