Tissueblue
.0125 mg/.5mL · Injection, Solution
- Prescription only
- Disclosing Agent
- Active substance
- Brilliant Blue G
- Made by
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-04-17
Disclosing Agent
- TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).
Excessive Staining Excess TissueBlue 0.025% should be removed from the eye immediately after staining.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).
From the official label · 2026-04-17 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-17
Do not take it if
None None
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- 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.
- 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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%.
- 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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness were observed between elderly and younger adult patients.
Quoted from the official label, section “Geriatric Use”.
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.
- 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 Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Quoted from the official label, section “Adverse Reactions”.
Strengths and forms
- forms & 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.
- TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- 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)
Quoted from the official label, section “How Supplied”.
How to store it
TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.
Quoted from the official label, section “Storage and Handling”.
What is in it
- TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a sterile solution of BBG (a dye) for intraocular ophthalmic use.
- Each mL of TissueBlue 0.025% contains BBG 0.25 mg, polyethylene glycol and buffered sodium chloride solution (sodium chloride, dibasic sodium phosphate, monobasic sodium phospage, water for injection).
- Phosphoric acid and/or sodium hydroxide may also be used for pH adjustment.
- 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 BBG.jpg
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. |
|---|---|
| Active substance | Brilliant Blue G |
| Strength | .0125 mg/.5mL |
| Form | Injection, Solution |
| Route | Intraocular; Ophthalmic |
| Packs | 10 POUCH in 1 CARTON / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS |
| NDC | 68803-722 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).