Label: 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 November 15, 2021

If you are a consumer or patient please visit this version.

  • 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: 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

  • Table of Contents
  • 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 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.

  • 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 0.025% - Contraindications section

    None

  • 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 before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula.

  • 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.

  • 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% - 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 47H 48N 3NaO 7S 2

    Chemical structure TissueBlue

  • 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% - 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.

  • 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.

  • 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

    Revision Date: 12/2019
    Made in Germany
    All trademarks are the property of their respective owners.

  • 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

  • INGREDIENTS AND APPEARANCE
    TISSUEBLUE 
    brilliant blue g injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68803-722
    Route of AdministrationINTRAOCULAR, OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRILLIANT BLUE G (UNII: M1ZRX790SI) (BRILLIANT BLUE G - UNII:M1ZRX790SI) BRILLIANT BLUE G0.0125 mg  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 2 mg  in 0.5 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.2 mg  in 0.5 mL
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) 3.1 mg  in 0.5 mL
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) 0.3 mg  in 0.5 mL
    WATER (UNII: 059QF0KO0R) 4743 g  in 0.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68803-722-0510 in 1 CARTON12/31/2019
    11 in 1 POUCH
    10.5 mL in 1 SYRINGE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20956912/31/2019
    Labeler - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (407522184)
    Registrant - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (407522184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmpur GmbH340805167manufacture(68803-722)