Cyclosporine Ophthalmic Solution
Generic Name: cyclosporine ophthalmic solution
Brand Names:
Vevye
11 DESCRIPTION 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...
Overview
11 DESCRIPTION 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...
Uses
1 INDICATIONS AND 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
2 DOSAGE AND 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.
Side Effects
6 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%).
Warnings
5 WARNINGS AND 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. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration.
Storage
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.
Frequently Asked Questions
What is Cyclosporine Ophthalmic Solution used for?▼
1 INDICATIONS AND 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 )
What are the side effects of Cyclosporine Ophthalmic Solution?▼
6 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%).
Can I take Cyclosporine Ophthalmic Solution during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration.
What are the important warnings for Cyclosporine Ophthalmic Solution?▼
5 WARNINGS AND 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.