이 정보는 교육 목적으로만 제공됩니다. 반드시 의료 전문가와 상담하시기 바랍니다. 자세히 알아보기

Cyclosporine Ophthalmic Solution

Prescription

상품명: VEVYE

제형
Drops
투여 경로
OPHTHALMIC
제조사
Harrow Eye, LLC

About This Medication

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 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

유효 성분

성분 함량
Cyclosporine -

적응증 및 용법

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 )

작용 원리

12.1 Mechanism of Action Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.

용량 및 투여 방법

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 Overview

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%).

경고 및 주의 사항

금기

약동학

12.3 Pharmacokinetics Following bilateral topical ocular dosing of one drop of VEVYE twice daily, the blood concentrations of cyclosporine were below the limit of quantification (0.1 ng/mL) at all timepoints.

Frequently Asked Questions

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 )

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 …

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 …

4 CONTRAINDICATIONS None. None. ( 4 )

Cyclosporine Ophthalmic Solution is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Similar Drops Products

Browse all Drops products →

References & Data Sources

의료 면책 조항

이 페이지의 정보는 교육 목적으로만 제공되며, 전문적인 의학적 조언, 진단 또는 치료를 대체하는 용도로 사용해서는 안 됩니다.

의학적 상태나 의약품에 관한 질문이 있으시면 반드시 의사 또는 자격을 갖춘 의료 전문가에게 조언을 구하시기 바랍니다.

데이터 출처: DailyMed (NLM), openFDA, MFDS

Medical Disclaimer

This content is for educational and informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making medication decisions.

Data sources: ChEMBL, PubChem, DailyMed.