Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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.; Principal Display Panel - 2 mL Carton Label NDC: 82667-900-02 Rx Only vevye ® (cyclosporine ophthalmic soliton) 0.1% For topical application In the eye Sterile, Non-Preserved 2 mL Principal Display Panel - 2 mL Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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.
- Principal Display Panel - 2 mL Carton Label NDC: 82667-900-02 Rx Only vevye ® (cyclosporine ophthalmic soliton) 0.1% For topical application In the eye Sterile, Non-Preserved 2 mL Principal Display Panel - 2 mL Carton Label
Overview
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
Indications & Usage
VEVYE indicated for the treatment of the signs and symptoms of dry eye disease. VEVYE (cyclosporine ophthalmic solution) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
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.
Warnings & Precautions
Care should be taken to not touch the eye or other surfaces with the bottle tip to avoid potential for eye injury and/or contamination. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces. 5.2 Use with Contact Lenses VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.
Contraindications
None. None. ( 4 )
Adverse Reactions
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%).
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.