Drug Reference

Cyclosporine

Calcineurin inhibitors

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Rx only

Fact box

Therapeutic class
Calcineurin inhibitors
Action class
Calcineurin Inhibitor Immunosuppressant
Mechanism
Calcineurin Inhibitors
Habit forming
No
Availability
Prescription (Rx)

Brand names

AtopicaCequaCyclavanceGengrafModulisNeoralOptimmuneRestasisSandimmuneSporimuneVerkaziaVevye

Available as

0.002 MG/MG · Ophthalmic Ointment25 MG · Oral Capsule50 MG · Oral Capsule5 ML · Injection0.9 MG/ML · Ophthalmic Solution100 MG · Oral Capsule0.4 ML · Ophthalmic Suspension1 MG/ML · Ophthalmic Suspension1 MG/ML · Ophthalmic Solution100 MG/ML · Oral Solution0.5 MG/ML · Ophthalmic Suspension10 MG · Oral Capsule

FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.

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 )
How it works
12.1 Mechanism of Action Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.
How to use / dosing
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%).

Safety advice

Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.

PregnancyUnsafe
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. Data Animal Data Oral administration of cyclosporine oral solution to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 7,250 and 48,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.67 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 4,100 and 14,500 times higher than the MRHOD, respectively). An oral dose of 45 mg/kg/day cyclosporine (approximately 10,900 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in mothers or offspring were observed at oral doses of up to 15 mg/kg/day (3600 times greater than MRHOD).
BreastfeedingConsult your doctor
…8.2 Lactation Risk Summary Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated.…
Breastfeeding details — LactMed (NLM) →
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )

Pediatric use

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

⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.

Current FDA labels (DailyMed)

42 marketed products on record (RxNorm)

Authoritative sources

Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.