TISSUEBLUE

TissueBlue 0.025% - Adverse Reactions section 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 Ophthalnic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

TissueBlue 0.025% - Contraindications section None None

TissueBlue 0.025% - Description section TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a sterile solution of BBG (a dye). Each mL of TissueBlue 0.025% contains BBG 0.25 mg, Polyethylene Glycol 40mg and Buffered Sodium Chloride solution (8.20 mg of sodium chloride, 3.10 mg sodium phosphate dibasic dodecahydrate, 0.30 mg sodium phosphate monobasic dihydrate, water for injection). The pH range of TissueBlue 0.025% Solution is between 7.3 and 7.6. The drug substance BBG has the chemical name Brilliant Blue G, a molecular weight of 854.02 and has the following chemical structure: Molecular formula: C 47 H 48 N 3 NaO 7 S 2 Chemical structure TissueBlue

TissueBlue 0.025% - Dosage & Administration Section TissueBlue 0.025% is carefully injected into the Balanced Salt Solution (BSS)-filled vitreous cavity using a blunt cannula attached to the pre-filled syringe, without allowing the cannula to contact the retina or allowing TissueBlue to get under the retina. Sufficient staining is expected within a few seconds. Following staining, all excess dye should be removed from the vitreous cavity. Inject TissueBlue 0.025% directly in a Balanced Salt Solution (BSS)-filled vitreous cavity. Excess TissueBlue should be removed from the vitreous cavity.

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

TissueBlue 0.025% - Clinical Pharmacology section TissueBlue 0.025% - Mechanism of action section 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.

TissueBlue 0.025% - Mechanism of action section 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.

20231005

5

TissueBlue 0.025% - Dosage forms & Strengths section 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.

TISSUEBLUE Brilliant Blue G SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE WATER BRILLIANT BLUE G BRILLIANT BLUE G POLYETHYLENE GLYCOL 3350

TissueBlue 0.025% - Nonclinical toxicology section TissueBlue 0.025% - Nonclinical toxicology section Studies to evaluate the potential for carcinogenicity or impairment of fertility of TissueBlue 0.025% have not been conducted. Brilliant Blue G was not mutagenic in the Ames assay, the in vitro mouse lymphoma assay, or the in vivo rat micronucleus assay.

NDA209569

TISSUEBLUE

Brilliant Blue G

68803-722

HUMAN PRESCRIPTION DRUG

INTRAOCULAR,OPHTHALMIC

Package Label - 0.5 mL TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% Staining Solution for Ophthalmic Surgery Protect from light, frost and moisture. Store at 15°C to 25°C (59°F to 77°F). Sterile. Active ingredients/Ingrédient actif: Brilliant Blue G 0.025% Inactive ingredients/Ingrédients inactifs: Water for injection, Sodium chloride, Sodium phosphate dibasic dihydrate, Sodium phosphate monobasic dihydrate, Polyethylene Glycol. NDC 68803-722-05 (One 0.5 mL syringe) NDC 68803-722-25 (Carton of five 0.5 mL syringes) Tissuebluebox.jpg

Rx Only 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.

TissueBlue 0.025% - Geriatric use section No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

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

TissueBlue 0.025% - Pregnancy section 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%.

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

TissueBlue 0.025% - How supplied section 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% - Storage and Handling section TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.