DailyMed - TISSUEBLUE- brilliant blue g injection, solution

NDC Code(s): 68803-722-05
Packager: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated October 5, 2023

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HIGHLIGHTS OF PRESCRIBING INFORMATION
TissueBlue: 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%. Initial U.S. Approval ...
TissueBlue: 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%. Initial U.S. Approval: 2019

INDICATIONS AND USAGE

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM). (1)
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. (3)

CONTRAINDICATIONS

None (4)

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. (5)

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. (6)

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 (6)

Revised: 12/2019
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Table of Contents
Table of Contents

FULL PRESCRIBING INFORMATION: CONTENTS*

TissueBlue 0.025% - Indications & Usage Section

TissueBlue 0.025% - Dosage & Administration Section

TissueBlue 0.025% - Dosage forms & Strengths section

TissueBlue 0.025% - Contraindications section

TissueBlue 0.025% - Warnings and Precautions section

TissueBlue 0.025% - Adverse Reactions section

TissueBlue 0.025% - Use in specific populations section

TissueBlue 0.025% - Pregnancy section

TissueBlue 0.025% - Lactation section

TissueBlue 0.025% - Pediatric use section

TissueBlue 0.025% - Geriatric use section

TissueBlue 0.025% - Description section

TissueBlue 0.025% - Clinical Pharmacology section

TissueBlue 0.025% - Mechanism of action section

TissueBlue 0.025% - Nonclinical toxicology section

TissueBlue 0.025% - Nonclinical toxicology section

TissueBlue 0.025% - How supplied section

*

Sections or subsections omitted from the full prescribing information are not listed.

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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).
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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 ...

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.
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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 a clear, bright blue, single-dose ophthalmic solution supplied in 2.25 mL syringes pre-filled to a volume of 0.5 mL.
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TissueBlue 0.025% - Contraindications section
None

None
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TissueBlue 0.025% - Warnings and Precautions section
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 ...

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.
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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 ...

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.
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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 ...

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.

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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 ...

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 47H 48N 3NaO 7S 2

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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 ...

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.

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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 ...

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.

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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 ...

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)
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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.

TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.
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SPL UNCLASSIFIED SECTION
Rx Only - Distributed by: Dutch Ophthalmic, USA - 10 Continental Drive, Bldg 1 - Exeter, NH 03833, USA - Phone: 800-75-DUTCH or 603-778-6929 ...

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.
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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 ...

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)

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Pharmpur GmbH		340805167	manufacture(68803-722)

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Published Date (What is this?)	Version	Files
Oct 6, 2023	5 (current)	download
Dec 29, 2022	4	download
Nov 16, 2021	3	download
Dec 21, 2020	2	download
Jan 3, 2020	1	download

Label: TISSUEBLUE- brilliant blue g injection, solution

Drug Label Information

INDICATIONS AND USAGE

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

FULL PRESCRIBING INFORMATION: CONTENTS*

TissueBlue 0.025% - Pregnancy section

TissueBlue 0.025% - Lactation section

TissueBlue 0.025% - Pediatric use section

TissueBlue 0.025% - Geriatric use section

TissueBlue 0.025% - Mechanism of action section

TissueBlue 0.025% - Nonclinical toxicology section

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TISSUEBLUE- brilliant blue g injection, solution

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TISSUEBLUE- brilliant blue g injection, solution

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