Brilliant Blue G

TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a clear, bright blue, single-dose ophthalmic solution supplied in 2.25 mL syringes pre-filled to a volume of 0.5 mL. TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

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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. Do not use the product if the plunger does not move smoothly to prime the cannula. 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.

Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. 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. To report SUSPECTED ADVERSE REACTIONS, contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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%. 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. Pediatric use The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established. Geriatric use No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

Brilliant Blue G has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated.