Hexaminolevulinate

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Blood in the urine.
• Trouble passing urine.
• Very bad bladder irritation.

(hex a mee noe LEV ue lin ate)

• HAL
• Hexaminolevulinate HCl
• Hexaminolevulinate Hydrochloride

Upon intravesical administration, hexaminolevulinate, an ester of aminolevulinic acid and a porphyrin precursor, enters urinary epithelial cells and is used in the formation of photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are thought to preferentially accumulate in neoplastic cells. Following photoexcitation with the Karl Storz D-Light Photodynamic Diagnostic (PDD) system (white and blue light), PpIX and PAPs fluoresce and can be used to detect malignant lesions on cystoscopy; fluorescence from tumor tissue appears bright red and demarcated.

Half-Life Elimination

Biphasic; Initial: 39 minutes; Terminal: ~76 hours

Detection of bladder cancer: Intravesical instillation: 100 mg (50 mL) instilled into empty bladder via urinary catheter

There are no dosage adjustments provided in the manufacturer's labeling.

Wear gloves for preparation (skin exposure may increase the risk for sensitization). Withdraw 50 mL of diluent (provided) into a 50 mL syringe with a luer lock tip. Inject 10 mL of diluent from the syringe into the hexaminolevulinate powder vial, and keeping the syringe attached, gently shake the vial to dissolve the powder. Withdraw all of the reconstituted solution back into the syringe, a final concentration of 2 mg/mL; cap syringe securely and mix gently.

Adequate animal reproduction studies have not been conducted.