Introduction

Topical immunomodulator; systemic immunosuppressive agent.

Uses for cycloSPORINE (EENT)

Keratoconjunctivitis Sicca

Used to increase tear production in adults whose tear production presumably is suppressed secondary to ocular inflammation related to keratoconjunctivitis sicca.

Increased tear production not observed in patients already receiving topical anti-inflammatory agents or using punctal plugs.

cycloSPORINE (EENT) Dosage and Administration

Administration

For ophthalmic use only. Not for injection. Not for subconjunctival injection or introduction directly into the anterior chamber of the eye.

Ophthalmic Administration

Apply topically to the eye as an ophthalmic emulsion.

Avoid contamination of emulsion container.

Invert unit-dose vial a few times before use to obtain a uniform, opaque, white emulsion.

Preservative-free emulsion is for single use only in one or both eyes; discard any unused portion immediately after administration.

Remove contact lenses prior to administration; may reinsert lenses 15 minutes after dose.

When used concomitantly with artificial tears, administer ophthalmic preparations at least 15 minutes apart.

Dosage

Adults

Keratoconjunctivitis Sicca

Ophthalmic

1 drop of a 0.05% emulsion into each eye twice daily, approximately 12 hours apart.

Contraindications

• Known hypersensitivity to cyclosporine or any ingredient in the formulation.

• Active ocular infections.

Warnings/Precautions

Warnings

Safety and efficacy not established in patients with history of herpes keratitis.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye. Caution advised if used in nursing women.

Pediatric Use

Safety and efficacy not established in children <16 years of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Ocular burning, conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, visual disturbance (e.g., blurring).

Administration

For ophthalmic use only. Not for injection. Not for subconjunctival injection or introduction directly into the anterior chamber of the eye.

Ophthalmic Administration

Apply topically to the eye as an ophthalmic emulsion.

Avoid contamination of emulsion container.

Invert unit-dose vial a few times before use to obtain a uniform, opaque, white emulsion.

Preservative-free emulsion is for single use only in one or both eyes; discard any unused portion immediately after administration.

Remove contact lenses prior to administration; may reinsert lenses 15 minutes after dose.

When used concomitantly with artificial tears, administer ophthalmic preparations at least 15 minutes apart.

Dosage

Adults

Keratoconjunctivitis Sicca

Ophthalmic

1 drop of a 0.05% emulsion into each eye twice daily, approximately 12 hours apart.

No formal drug interaction studies to date.