FDA

Cysview Kit

Approved 28 May 2010Into the bladderFor solution

Indications

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 )

1.1Limitations 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) ].

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 )

Warnings and precautions

Anaphylaxis: have trained personnel and therapies available. ( 5.1 ). Failed Detection: Cysview may not detect all malignant lesions. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only. ( 5.2 ) False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy. ( 5.3 )

5.1Anaphylaxis

Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview [ see Adverse Reactions (6.2) ]. Prior to and during use of the Cysview, have trained personnel and therapies available for the treatment of anaphylaxis.

At a glance

Brand name: Cysview Kit
Active substance: hexaminolevulinate hydrochloride
Route: Into the bladder
Dosage form: For solution
Applicant: Photocure Asa
Status: Prescription
FDA approval: 28 May 2010
Application: NDA022555-001

Indications

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 )

1.1Limitations 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) ].

Contraindications

Warnings and precautions

5.1Anaphylaxis

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.

6.1Clinical 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) ].

6.2Postmarketing 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.

Cysview Kit

Indications

1.1Limitations of Use

Contraindications

Warnings and precautions

5.1Anaphylaxis

At a glance

Two medicines in one question?

Cysview Kit

Indications

1.1Limitations of Use

Contraindications

Warnings and precautions

5.1Anaphylaxis

At a glance

Two medicines in one question?

5.2Failed Detection

5.3False Positive Fluorescence

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Study Experience

6.2Postmarketing Experience

Composition

Official product information