Tissueblue

Patient Information

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

Description

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: C₄₇H₄₈N₃NaO₇S₂.

Indications

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

Dosage And Administration

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.

How Supplied

Dosage Forms And Strengths

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.

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.

Dutch Ophthalmic, USA, 10 Continental Drive, Bldg 1 Exeter, NH 03833, USA  Revised: Dec 2019

Side Effects

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.

Drug Interactions

No Information provided

WarningS

Included as part of the PRECAUTIONS section.

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

Use In Specific Populations

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.

Overdose

No information provided.

Contraindications

None

Clinical Pharmacology

Mechanism Of Action

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.