Hexaminolevulinate Hydrochloride
FDA Drug Information • Also known as: Cysview
- Brand Names
- Cysview
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Cysview contains hexaminolevulinate hydrochloride, an optical imaging drug that in solution form is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. The chemical formula for hexaminolevulinate hydrochloride is C 11 H 21 NO 3 ∙HCl. Its molecular weight is 251.76 and it has the following structural formula: Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is intended for intravesical administration only after reconstitution with the supplied 50 mL DILUENT. Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution and DILUENT for Cysview are supplied together as a kit. Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is supplied as a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow, powder containing 100 mg of hexaminolevulinate hydrochloride (equivalent of 85 mg of hexaminolevulinate) in a 10 mL clear glass vial. The DILUENT for Cysview is a sterile, non-pyrogenic solution (pH 6) containing 0.61 mg/ mL disodium hydrogen phosphate, 0.58 mg/mL of potassium dihydrogen phosphate, 7.02 mg/mL of sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection. It is a clear, colorless solution, free from visible particles, and is provided in a 50 mL plastic prefilled syringe. The reconstituted solution of Cysview contains 2 mg/ml of hexaminolevulinate hydrochloride and is colorless to pale yellow. It is free from visible particles and has a pH between 5.7 and 6.2. Chemical Structure
What Is Hexaminolevulinate Hydrochloride Used For?
1 INDICATIONS AND USAGE Cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC ® ) as an adjunct to the white light cystoscopy. Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC ® ) as an adjunct to the white light cystoscopy. Important Limitations of Use: Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1.1 , 5.2 ) 1.1 Limitations of Use Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [ see Warnings and Precautions (5.2) ].
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Training in blue light cystoscopy with the Karl Storz D-Light C PDD system is essential prior to the use of Cysview. ( 2.5 ) Reconstitute Cysview powder with the supplied 50 mL DILUENT under aseptic conditions. ( 2.2 ) Use solution of Cysview shortly after reconstitution. If unable to use, the solution may be stored for up to 2 hours in a refrigerator at 2°-8°C (36°-46°F) in the labeled syringe. Discard after 2 hours. ( 2.2 , 16 ) Instill 50 mL of reconstituted solution of Cysview into the emptied bladder via an intravesical catheter. Retain in the bladder for 1 hour before evacuating and performing cystoscopic examination. ( 2.3 , 2.5 ) First perform a complete cystoscopic examination of the entire bladder under white light and then repeat the examination of the entire bladder under blue light. Record and document information about location and appearance of suspicious lesions and areas seen under both white and blue light. ( 2.5 ) 2.1 Recommended Dose The recommended dose for adults is 50 mL of reconstituted solution of Cysview [ see Dosage and Administration (2.2) ], instilled into the bladder via a urinary catheter [ see Dosage and Administration (2.3) ]. 2.2 Reconstitution of Cysview Cysview is supplied as a kit containing: a clear glass vial labeled as Cysview (hexaminolevulinate HCl) for Intravesical Solution containing 100 mg hexaminolevulinate hydrochloride as a powder, a prefilled syringe labeled as DILUENT for Cysview containing 50 mL of the diluent, and a catheter adapter. The kit may be supplied as two options; with or without a vial adapter for use during reconstitution. Perform all steps under aseptic conditions. Wear gloves during the reconstitution procedure; skin exposure to hexaminolevulinate hydrochloride may increase the risk for sensitization to the drug. Cysview Powder Cysview Diluent Plunger Rod Figure 1. Figure 1 Figure 1a Reconstitution Using a Vial Adapter Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (Figure 1). Figure 2. Remove the plastic cap from the vial. Remove the TyveK® cover from the vial adapter blister package. Do not remove the vial adapter from the package. Place the Cysview vial on a flat surface. Using the blister package to hold the vial adapter, connect to the vial with a downward vertical motion. The vial adapter snaps onto the vial as the spike penetrates the rubber stopper of the vial. Remove the plastic blister package and discard it. Take care not to touch the exposed end of the vial adapter (Figure 2). Figure 3. Remove the cap from the prefilled syringe and carefully retain it for subsequent reattachment to the syringe. Hold the prefilled syringe upright and carefully press the plunger rod upward to remove air. Connect the syringe to the vial adapter. Inject about 10 mL of the diluent from the prefilled syringe down into the vial. The vial should be about ¾ full (Figure 3). Figure 4. Without...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS Anaphylaxis has been reported following exposure to Cysview [ see Warnings and Precautions (5.1) ]. The most common adverse reaction reported in patients who received Cysview was bladder spasm, occurring in 2% of patients, followed by dysuria, hematuria and bladder pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Photocure Inc. at 1-855-297-8439 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In seven clinical trials, safety data were obtained from 1,628 patients, aged 32 to 96 years with a median age of 70 years, all primarily Caucasian and approximately 75% male. All patients were evaluated after a single instillation of 50 mL solution of Cysview, and 103 patients received a repeat administration of Cysview. Of these patients, 170 (10.4%) patients reported at least one adverse reaction. The most common adverse reaction was bladder spasm (reported in 2.0% of the patients) followed by dysuria, hematuria, and bladder pain. No patients experienced anaphylaxis. In the randomized controlled clinical study, adverse reactions were similar in nature and rate between the study drug group and the control group. In a controlled study using Cysview in the surveillance setting, adverse reaction types were similar [ see Clinical Studies (14) ]. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Cysview. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported during post-marketing use of Cysview.
Drug Interactions
7 DRUG INTERACTIONS No specific drug interaction studies have been performed.
Contraindications
4 CONTRAINDICATIONS Cysview is contraindicated in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Do not use Cysview in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on Cysview use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal [see Clinical Pharmacology (12.3) ]. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Overdosage
10 OVERDOSAGE No adverse events were reported in a dose-finding study conducted among patients whose bladders were instilled with twice the recommended concentration (dose) of solution of Cysview.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Cysview is supplied as a kit labeled Cysview (hexaminolevulinate HCl) Kit for Intravesical Solution, 100 mg. The kit may be supplied as two options; with or without a vial adapter, and contains: Cysview kit with a vial adapter Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg, as a powder in a 10 mL clear glass vial. One plastic prefilled syringe of DILUENT for Cysview, 50 mL. One vial adapter for use during reconstitution. The vial adapter is either a "West Vented Vial Adapter" or a "West Mixject Dispensing Pin". One Luer Lock catheter adapter (to connect the syringe containing the reconstituted solution of Cysview to the urethral catheter for bladder instillation of Cysview). NDC 10511-3001-2 Cysview kit without a vial adapter Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg , as a powder in a 10 mL clear glass vial. One plastic prefilled syringe of DILUENT for Cysview, 50 mL. One Luer Lock catheter adapter (to connect the syringe containing the reconstituted solution of Cysview to the urethral catheter for bladder instillation of Cysview). NDC 10511-3001-3 Storage Store Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution at 20°-25°C (68°-77°F); excursions are permitted to 15°-30°C (59°-86°F). Do not use beyond the expiry date printed on the carton. Use the solution of Cysview shortly after reconstitution. If unable to use within this time period, the reconstituted solution can be stored under refrigeration at 2°-8°C (36°-46°F) for up to 2 hours in the labeled syringe.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.