Brilliant Blue G Ophthalmic Solution(Tissue Blue)-@- (Dec 2019)- Dye used in eye surgery
Indication:
U.S. FDA APPROVED DRUGS DURING 2019
Sr.No.44
Name of the Drug- Tissue blue
Active Ingredient - Brilliant Blue G Ophthalmic Solution
Pharmacological Classification-
Dye Used in eye Surgery
Date of Approval - 12/20/2019
(Ref- FDA approved List 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).
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.
Adverse Reaction:
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.
Contra-Indications:
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.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).
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.
Patient Information:
Patient Information
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. (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 www.fda.gov
Pharmacology/ Pharmacokinetics:
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, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated.
Pregnancy and lactation:
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.
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