Hexvix (Hexaminolevulinate)

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

• Enhances visualization of carcinoma in situ and papillary tumors under blue‑light cystoscopy.
• Allows targeted biopsy of fluorescent lesions.
• Supports assessment of tumor margins after transurethral resection.
• Can be used in conjunction with standard white‑light cystoscopy to improve diagnostic yield.
• May aid in surveillance cystoscopies for patients with a history of bladder cancer.
• May be employed in clinical trials evaluating new bladder‑cancer therapies that require precise lesion mapping.

• After intravesical administration, hexaminolevulinate is preferentially taken up by malignant urothelial cells. Inside these cells it is metabolized via the heme biosynthetic pathway to protoporphyrin IX, a fluorescent porphyrin. Protoporphyrin IX accumulates to concentrations that emit red‑orange fluorescence when excited by blue light (400–450 nm). This selective fluorescence highlights cancerous tissue while normal urothelium remains non‑fluorescent, facilitating visual discrimination during cystoscopy.

Adverse reactions reported after intravesical Hexvix are generally related to the local administration and the photosensitizing properties of the agent.

Common

• Bladder discomfort or urgency, typically occurring during or shortly after the instillation.
• Dysuria (painful urination) that may last a few hours.
• Transient hematuria, usually mild and self‑limiting.
• Mild abdominal cramping or suprapubic pressure.
• Flank pain or renal colic‑like sensation.

Serious

• Severe allergic reaction (anaphylaxis) presenting with rash, hypotension, or respiratory distress.
• Persistent urinary retention requiring catheterisation or medical intervention.
• Acute cystitis with fever, chills, and marked suprapubic tenderness.
• Photosensitivity reactions affecting skin exposed to bright or ultraviolet light, potentially causing erythema or burns.
• Bladder perforation (procedure‑related) leading to abdominal pain, hematuria, or signs of peritonitis.

Before using Hexvix, clinicians should evaluate patient suitability and follow specific procedural precautions to minimise risks.

• Confirm absence of active urinary tract infection or gross hematuria before instillation.
• Ensure the bladder is emptied, then filled with the prescribed volume of Hexvix solution.
• Avoid exposure of skin and eyes to bright or ultraviolet light for several hours after the procedure.
• Review patient history for hypersensitivity to porphyrins or related compounds.
• Use caution in patients with severe renal impairment, obstructive uropathy, or unknown pregnancy status.

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

Avoid

• Concurrent use of systemic photosensitizers (e.g., porfimer sodium, aminolevulinic acid) that could amplify fluorescence or cause widespread photosensitivity.
• Exposure to intense blue or ultraviolet light sources during the fluorescence window.

Use with caution

• Intravesical chemotherapeutic agents administered shortly before or after Hexvix; timing should be coordinated to avoid interference.
• Anticoagulant therapy, as bladder instrumentation may increase bleeding risk.
• Patients with severe hepatic dysfunction, because altered porphyrin metabolism could affect systemic exposure.
• Renal replacement therapy patients, because accumulation of porphyrin metabolites may be altered.