BRIEF SUMMARY

BRILLIANT BLUE-(Dec 2019)

Indn.     To treat reractory bladder cancer 

Comp-    TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.                                                                     Inject TissueBlue 0.025% directly in a Balanced Salt Solution (BSS)-filled vitreous cavity.

ADR-   Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. 

CI-    None

WARNINGS -

­ Excessive staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining.

Use of the syringe: Make sure the plunger moves smoothly before injecting the solution. 

Pat Inform-                                                                                                            TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% is supplied as 0.5 mL of Brilliant Blue G Ophthalmic Solution, 0.025% in a sterile, single-dose Luer Lok, 2.25 mL glass syringe, with a grey rubber plunger stopper and tip cap with polypropylene plunger rod in a pre-formed polypropylene blister pouch sealed with a Tyvek® lid. NDC 68803-722-05 (One 0.5 mL syringe) NDC 68803-722-25 (Carton of five 0.5 mL syringes) TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F).

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U.S. FDA APPROVED DRUGS SURING 2019                                         

Serial No 44

Name of the Drug-    TISSUE BLUE

Active Ingredient -   Tissue Blue Brilliant

Pharmacological Classification-

                                                    To treat reractory bladder cancer                                                                                                                                                                                                                                                                                                                       Date of Approval-          December 2019

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use                               TissueBlue 0.025% safely and effectively.                                                                        See full prescribing information for TissueBlue 0.025%. TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% For Intraocular Ophthalmic Administration

Initial U.S. Approval: 2019

INDICATIONS AND USAGE-

 TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

ADVERSE REACTIONS-

­ Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. 

CONTRAINDICATIONS-

­ None

WARNINGS AND PRECAUTIONS-

­ Excessive staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining.

Use of the syringe: Make sure the plunger moves smoothly before injecting the solution. 

DOSAGE AND ADMINISTRATION-

­ Inject TissueBlue 0.025% directly in a Balanced Salt Solution (BSS)-filled vitreous cavity.

 Excess TissueBlue should be removed from the vitreous cavity.

DOSAGE FORMS AND STRENGTHS-

 TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL. 

HOW SUPPLIED/STORAGE AND HANDLING-

TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% is supplied as 0.5 mL of Brilliant Blue G Ophthalmic Solution, 0.025% in a sterile, single-dose Luer Lok, 2.25 mL glass syringe, with a grey rubber plunger stopper and tip cap with polypropylene plunger rod in a pre-formed polypropylene blister pouch sealed with a Tyvek® lid. NDC 68803-722-05 (One 0.5 mL syringe) NDC 68803-722-25 (Carton of five 0.5 mL syringes) TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F).

Protect from light, frost and moisture. Rx Only U.S. Food and Drug Administration Silver Spring, MD 20993

Distributed by: Dutch Ophthalmic, USA 10 Continental Drive, Bldg 1 Exeter, NH 03833, USA Phone: 800-75-DUTCH or 603-778-6929 Revision Date: 12/2019 Made in Germany All trademarks are the property of their respective owners.

CLINICAL PHARMACOLOGY-

1 Mechanism of Action-

 Brilliant Blue G has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, maki

USE IN SPECIFIC POPULATIONS-

1 Pregnancy Risk Summary-

There are no available data on the use of TissueBlue 0.025% in pregnant women to inform a drug associated risk.

Systemic absorption of TissueBlue 0.025% in humans is expected to be negligible following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures.

Due to the negligible systemic exposure, it is not expected that maternal use of TissueBlue 0.025% will result in fetal exposure to the drug.

Adequate animal reproduction studies were not conducted with TissueBlue 0.025%.

2.Lactation Risk Summary-

No data are available regarding the presence of Brilliant Blue G in human milk after intraocular administration of TissueBlue 0.025%, or the effects on the breastfed infant or the effects on milk production.

However, breastfeeding is not expected to result  in exposure of the child to Brilliant Blue G due to the expected negligible systemic exposure of BBG in humans following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures.

3. Pediatric Use -                                                                                                          The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established.

4. Geriatric Use-                                                                                                                No overall differences in safety or effectiveness were observed between elderly and younger adult patients.