Vevye

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.
• ( 2 )
• 2.1 Recommended Dosage Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.
• 2.2 Administration Instructions Wash hands before using.
• Gently pull the lower eyelid downward.
• Tip the bottle upside down over the eye to allow one drop to dispense on its own into the eye.
• If a drop does not dispense after a few seconds, gently apply slight pressure to the sides of the bottle while holding over the eye.
• Note: You may not feel the drop falling into your eye.
• If VEVYE is used with other eye drops, a 15-minute interval between products should occur.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most common adverse reaction following the use of VEVYE were instillation site reactions (8%).
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise patients to read the FDA-approved patient labeling (Instructions for Use).
• Risk of Contamination Advise patients to wash their hands well before each use.
• Advise patients not to allow the dropper tip to touch the eye or any other surface, as this may contaminate the solution [see Warning and Precautions ( 5.1 )] .
• Contact Lens Wear Contact lenses should be removed prior to instillation of VEVYE and may be reinserted 15 minutes following administration [see Warning and Precautions ( 5.2 )] .
• HARROW ® Distributed by Harrow Eye, LLC Nashville, TN 37215 USA © 2024

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Clear, colorless non-preserved ophthalmic solution containing cyclosporine 0.1% (1 mg/mL), delivering 0.01 mg of cyclosporine per one drop (0.01 mL). Ophthalmic solution containing cyclosporine 0.1%. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• VEVYE is a sterile, clear, colorless non-aqueous ophthalmic solution packaged in multiple-dose eye drop bottles delivering single drops of approximately 0.01 mL volume.
• Each unit contains 2 mL of VEVYE in a 5 mL transparent squeezable polypropylene bottle with a transparent polyethylene tip and a white polyethylene cap with tamper-evident ring.
• NDC 82667-900-02 Storage and Handling
• Do not use if tamper-evident ring attached to the white cap is not intact.
• After first opening the tamper-evident ring of the cap remains on the bottle neck.
• Retain the cap and keep the bottle tightly closed when not in use.
• Store at 15°C to 25°C (59°F to 77°F).
• Do not freeze or refrigerate.
• After opening, VEVYE can be used until the expiration date on the bottle.

Quoted from the official label, section “How Supplied”.

What is in it

• VEVYE (cyclosporine ophthalmic solution) 0.1% contains the immunomodulatory agent cyclosporine.
• Cyclosporine's chemical name is Cyclo[[€-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:
• Structural Formula Formula:
• C 62 H 111 N 11 O 12 , Molecular weight:
• 1202.6 Cyclosporine is a white powder that is solubilized in perfluorobutylpentane, a semi-fluorinated alkane vehicle.
• VEVYE is supplied as a 2 mL sterile, clear, colorless, non-aqueous ophthalmic solution for topical ophthalmic use.
• VEVYE ® contains:
• Active:
• cyclosporine 0.1% Inactives:
• perfluorobutylpentane, ethanol (anhydrous).
• The solution does not contain water or anti-microbial preservatives.
• As a water free product, there is no associated pH and no osmolarity.
• Structural Formula

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.

Details

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).

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