Cysview

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis

Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview [see ADVERSE REACTIONS]. Prior to and during use of the Cysview (hexaminolevulinate hydrochloride intravesical solution) , have trained personnel and therapies available for the treatment of anaphylaxis. The safety of repetitive Cysview (hexaminolevulinate hydrochloride intravesical solution) exposures has not been evaluated.

Failed Detection

Cysview (hexaminolevulinate hydrochloride intravesical solution) may fail to detect some bladder tumors, including malignant lesions. Cysview (hexaminolevulinate hydrochloride intravesical solution) is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. In the controlled clinical trial, Cysview (hexaminolevulinate hydrochloride intravesical solution) failed to detect 10% of lesions confirmed as malignant within the study drug group [see Clinical Studies]. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light [see DOSAGE AND ADMINISTRATION].

False Fluorescence

Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In the controlled clinical study, biopsies from one of every four fluorescent areas showed neither dysplasia nor carcinoma, if the areas were not also identified during white light cystoscopy [see Clinical Studies]. In addition to these false detections, fluorescent areas within the bladder mucosa may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination.

The presence of urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. To enhance the diagnostic utility of Cysview (hexaminolevulinate hydrochloride intravesical solution) with the Karl Storz D-Light C PDD System:

  • ensure the bladder is emptied of urine prior to the instillation of fluids at cystoscopy;
  • biopsy/resect bladder mucosal lesions only following completion of both white light and blue light cystoscopy;

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies in animals have been conducted to evaluate the carcinogenic potential of hexaminolevulinate hydrochloride.

Hexaminolevulinate hydrochloride was not mutagenic in in vitro reverse mutation tests in bacteria, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in vivo micronucleus test in mice after intravenous injection of doses up to 45 mg/kg in the absence of light activation. Adequate studies have not been performed to evaluate the genetic toxicity of hexaminolevulinate hydrochloride in the presence of light activation.

Adequate reproductive and developmental toxicity studies in animals have not been performed to evaluate the effects of hexaminolevulinate hydrochloride on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Cysview (hexaminolevulinate hydrochloride intravesical solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview (hexaminolevulinate hydrochloride intravesical solution) is administered to nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of 1823 subjects in clinical studies of Cysview (hexaminolevulinate hydrochloride intravesical solution) , 67% were 65 years and over while 34% were 75 years and over. No clinically important differences in safety or efficacy have been observed between older and younger patients in the controlled study.

Last reviewed on RxList: 6/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.