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TissueBlue (Brilliant Blue G Ophthalmic Solution 0.025% For Intraocular Ophthalmic Administration): Side Effects, Uses, Dosage, Interactions, Warnings

TissueBlue

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/19/2023

Drug Summary

What Is TissueBlue?

TissueBlue (brilliant blue G ophthalmic solution) 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

What Are Side Effects of TissueBlue?

TissueBlue may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • blindness,
  • blurred vision,
  • decreased vision or other vision changes,
  • seeing "floaters" or light flashes,
  • seeing floating spots before the eyes, and
  • a veil or curtain appearing across any part of your vision

Get medical help right away, if you have any of the symptoms listed above.

Side effects of TissueBlue include:

  • retinal complications (retinal break, tear, hemorrhage, and detachment) and
  • cataracts

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for TissueBlue

The dose of is TissueBlue 0.025% injected directly in a Balanced Salt Solution (BSS)-filled vitreous cavity.

TissueBlue In Children

The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established.

What Drugs, Substances, or Supplements Interact with TissueBlue?

TissueBlue 0.025% may interact with other medicines.

Tell your doctor all medications and supplements you use.

TissueBlue During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using TissueBlue 0.025%; it is unknown how it could affect a fetus. 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. It is unknown if TissueBlue 0.025% passes into breast milk. 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 procedure. Consult your doctor before breastfeeding.

Additional Information

Our TissueBlue (brilliant blue G ophthalmic solution) 0.025% for Intraocular Ophthalmic Administration Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description for TissueBlue

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:

TissueBlue Structural Formula - Illustration

Molecular formula: C47H48N3NaO7S2.

Uses for TissueBlue

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

Dosage for TissueBlue

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. Sufficiient 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 for TissueBlue

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 for TissueBlue

No Information provided

Warnings for TissueBlue

Included as part of the PRECAUTIONS section.

Precautions for TissueBlue

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 Information for TissueBlue

No information provided.

Contraindications for TissueBlue

None

Clinical Pharmacology for TissueBlue

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.

Patient Information for TissueBlue

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

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.