One drop BID in each eye, approximately 12 hours apart
Sign improvement on corneal staining begins at day 28 and builds through day 84, without symptom relief.
Contraindications
None.
Available Forms
0.09% (0.9 mg/mL) preservative-free solution, 0.25 mL single-use vials, 60-vial box (6 pouches of 10) that must be dispensed intact
Mechanism of Action
Calcineurin inhibitor immunosuppressant; blocking calcineurin suppresses the T-cell cytokine signaling that drives ocular surface inflammation, and the label calls topical cyclosporine a partial immunomodulator whose exact ocular mechanism is not known. Supplied as a clear aqueous nanomicellar solution of cyclosporine 0.09%, and blood levels after BID dosing are at or below 0.2 ng/mL.
Warnings & Precautions
Vial tip contamination: Contact between the vial tip and the eye or any other surface risks eye injury and contamination of the solution.
Contact lens wear: Not to be administered during lens wear; remove lenses before instillation and reinsert 15 minutes afterward.
Common Side Effects
Ocular, greater than 5%: Pain on instillation of drops 22%, conjunctival hyperemia 6%.
Ocular, 1% to 5%: Blepharitis, eye irritation.
Systemic, 1% to 5%: Headache, urinary tract infection.
Pregnancy & Lactation
Pregnancy: No adequate and well-controlled studies in pregnant women. Oral cyclosporine was not teratogenic in rats or rabbits at clinically relevant doses; teratogenicity appeared only at maternally toxic doses roughly 3200 and 21000 times the maximum recommended human ophthalmic dose.
Lactation: Blood concentrations after topical dosing are low, and presence in human milk after topical administration is unknown. Oral cyclosporine given to rats during lactation produced no adverse effects in offspring at clinically relevant doses.