Trypan Blue

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# Overview
Trypan Blue is an Ophthalmologic agent that is FDA approved for the procedure of ophthalmic posterior surgery and facilitates removal of epiretinal tissue..   Common adverse reactions include discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- MembraneBlueTM 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue.

# Dosage
- Make sure the plunger moves smoothly before use. Prime the syringe prior to use by retracting the plunger before injecting the fluid. Alternatively, twist the plunger into the stopper in a clockwise motion until tight. Once tight, continue turning the plunger in a clockwise motion until the stopper rotates freely within the syringe, two or three rotations. The syringe is now primed and suitable for injection.
- Before injection of MembraneBlueTM 0.15% perform a fluid-air exchange, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlueTM 0.15%. MembraneBlueTM 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlueTM 0.15% syringe, without allowing the cannula to contact or damage the retina. Sufficient staining is expected on contact with the membrane. All excess dye should be removed from the vitreous cavity before performing an air-fluid exchange, to prevent unnecessary spreading of the dye.
- MembraneBlueTM 0.15% can also be injected directly in a BSS filled vitreous cavity (instead of injecting under air). Clinical use demonstrated that, after complete vitreous and posterior hyaloid removal, sufficient staining is achieved after 30 seconds of application under BSS.
- MembraneBlueTM 0.15% is intended to be applied directly on the areas where membranes could be present, staining any portion of the membrane which comes in contact with the dye. The dye does not penetrate the membrane.

# DOSAGE FORMS AND STRENGTH
- MembraneBlueTM 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Trypan Blue in adult patients.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Trypan Blue in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indications
- MembraneBlueTM 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue.

# Dosage
- Make sure the plunger moves smoothly before use. Prime the syringe prior to use by retracting the plunger before injecting the fluid. Alternatively, twist the plunger into the stopper in a clockwise motion until tight. Once tight, continue turning the plunger in a clockwise motion until the stopper rotates freely within the syringe, two or three rotations. The syringe is now primed and suitable for injection.
- Before injection of MembraneBlueTM 0.15% perform a fluid-air exchange, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlueTM 0.15%. MembraneBlueTM 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlueTM 0.15% syringe, without allowing the cannula to contact or damage the retina. Sufficient staining is expected on contact with the membrane. All excess dye should be removed from the vitreous cavity before performing an air-fluid exchange, to prevent unnecessary spreading of the dye.
- MembraneBlueTM 0.15% can also be injected directly in a BSS filled vitreous cavity (instead of injecting under air). Clinical use demonstrated that, after complete vitreous and posterior hyaloid removal, sufficient staining is achieved after 30 seconds of application under BSS.
- MembraneBlueTM 0.15% is intended to be applied directly on the areas where membranes could be present, staining any portion of the membrane which comes in contact with the dye. The dye does not penetrate the membrane.

# DOSAGE FORMS AND STRENGTH
- MembraneBlueTM 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Trypan Blue in pediatric patients.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-Supported Use of Trypan Blue in pediatric patients.

# Contraindications
- MembraneBlueTM 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it.

# Warnings
Excessive staining:
- It is recommended that after injection all excess MembraneBlueTM 0.15% be immediately removed from the eye.
Priming of the syringe:
- Make sure the plunger moves smoothly before use: first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.

# Adverse Reactions

## Clinical Trials Experience
- Adverse reactions reported following use of MembraneBlueTM 0.15% include discoloration of high water content hydrogen intraocular lenses  and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week.

## Postmarketing Experience
- There is limited information regarding Postmarketing Experience of Trypan Blue in the drug label.

# Drug Interactions
There is limited information regarding Trypan Blue Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Teratogenic Effects: Pregnancy Category C. Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS):
- There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trypan Blue in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Trypan Blue during labor and delivery.

### Nursing Mothers
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.

### Pediatric Use
- The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

### Geriatic Use
- No overall differences in safety and effectiveness have been observed between elderly and younger patients.

### Gender
There is no FDA guidance on the use of Trypan Blue with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Trypan Blue with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Trypan Blue in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Trypan Blue in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trypan Blue in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Trypan Blue in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
- There is limited information regarding Monitoring of Trypan Blue in the drug label.

# IV Compatibility
- There is limited information regarding IV Compatibility of Trypan Blue in the drug label.

# Overdosage
- There is limited information regarding Chronic Overdose of Trypan Blue in the drug label.

# Pharmacology

## Mechanism of Action
- MembraneBlueTM 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).

## Structure
- MembraneBlueTM 0.15% (trypan blue ophthalmic solution) is a sterile solution of trypan blue (an acid di-azo group dye). MembraneBlueTM 0.15% selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures.
- Each mL of MembraneBlueTM 0.15% contains: 1.5 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na2HPO4.2H2O); 0.3 mg sodium di-hydrogen orthophosphate (NaH2PO4.2H2O); 8.2 mg sodium chloride (NaCl); and water for injection. The pH is 7.3 - 7.6. The osmolality is 257-314 mOsm/kg.
- The drug substance trypan blue has the chemical name 3,3- bis(5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C34H24N6Na4O14S4, and has the following chemical structure:

## Pharmacodynamics
- There is limited information regarding Pharmacodynamics of Trypan Blue in the drug label.

## Pharmacokinetics
- There is limited information regarding Pharmacokinetics of Trypan Blue in the drug label.

## Nonclinical Toxicology
- Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person, assuming total absorption).
- Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro.

# Clinical Studies
There is limited information regarding Clinical Studies of Trypan Blue in the drug label.

# How Supplied
- MembraneBlueTM 0.15% is supplied as follows:
- 0.5 mL of MembraneBlueTM 0.15% in a sterile single-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Five pouched products are packed in one distribution box.

## Storage
- MembraneBlueTM 0.15% is stored at 15-25oC (59-77oF). Protect from direct sunlight.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Trypan Blue in the drug label.

# Precautions with Alcohol
- Alcohol-Trypan Blue interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- MEMBRANEBLUE

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price