Version May 2024
Keratoconjunctivitis sicca:
Emulsion 0.05% (eg, Restasis): Adolescents ≥16 years: Ophthalmic: Instill 1 drop in each eye every 12 hours.
Solution 0.09% (eg, Cequa): Adolescents ≥18 years: Ophthalmic: Instill 1 drop in each eye every 12 hours.
Vernal keratoconjunctivitis, severe:
Treatment:
Ophthalmic emulsion 0.1% (eg, Verkazia): Children ≥4 years and Adolescents: Ophthalmic: Instill 1 drop in affected eye(s) 4 times daily until signs/symptoms resolve. Treatment may be reinitiated if there is a recurrence (Ref).
Ophthalmic emulsion 0.05% (eg, Restasis): Limited data available: Children ≥5 years and ≤14 years: Ophthalmic: Instill 1 drop in affected eye(s) 4 times daily. Dosing based on experience from a prospective trial (n=54; age: 9.6 ± 2.5 years [range: 5 to 14 years]) and a case series (n=6; age: 6 to 14 years) (Ref). Higher concentrations of cyclosporine have also shown efficacy in clinical trials (1% and 2%); however, those formulations have a different vehicle and are not commercially available in the United States (Ref).
Prevention: Limited data available:
Ophthalmic emulsion 0.05% (eg, Restasis): Children ≥6 years and Adolescents: Ophthalmic: Instill 1 drop in affected eye(s) twice daily; dosing based on a blinded, comparative (ketotifen) crossover trial in 34 pediatric patients (mean age: 14 ± 7 years) with severe but stable vernal keratoconjunctivitis; over a 2-year period, cyclosporine showed a statistically significant reduction in number of recurrences or flare-up compared to ketotifen; both drugs were considered to be well-tolerated (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
(For additional information see "Cyclosporine (ciclosporin) (ophthalmic): Drug information")
Dry eye disease (Cequa, Restasis, Vevye): Ophthalmic: Instill 1 drop in each eye twice daily (~12 hours apart).
Vernal keratoconjunctivitis (Verkazia): Ophthalmic: Instill 1 drop in each affected eye 4 times daily (morning, noon, afternoon, and evening) until signs/symptoms resolve. Treatment may be reinitiated if there is a recurrence.
Missed dose: If a dose is missed, treatment should be continued as normal, at the next scheduled administration.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Burning sensation of eyes (17%), eye pain (1% to 22%)
1% to 10%:
Genitourinary: Urinary tract infection (1% to 5%)
Nervous system: Headache (1% to 5%)
Ophthalmic: Blepharitis (1% to 5%), blurred vision (1% to 5%), conjunctival hyperemia (1% to 6%), decreased visual acuity (3% to 5%), epiphora (1% to 5%), eye discharge (1% to 5%), eye discomfort (≤6%), eye irritation (1% to 5%), eye pruritus (1% to 8%), foreign body sensation of eye (≤6%), ocular hyperemia (4%), stinging of eyes (1% to 5%), visual disturbance (1% to 5%)
Respiratory: Cough (5%), upper respiratory tract infection (2%)
Postmarketing: Hypersensitivity: Angioedema, hypersensitivity reaction
Hypersensitivity to cyclosporine or any component of the formulation.
Vevye: There are no contraindications listed in the US labeling.
Canadian labeling: Additional contraindications (not in US labeling):
Cequa, Verkazia: Patients with active or suspected ocular or periocular infection; patients with ocular or periocular malignancies or premalignant conditions.
Restasis, Restasis multidose: Patients with active ocular infections.
Special populations:
• Contact lens wearers: Remove contact lens prior to administration and wait 15 minutes before reinserting.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: To avoid contamination, do not touch vial tip to eyelids or other surfaces.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Emulsion, Ophthalmic [preservative free]:
Restasis: 0.05% (30 ea, 60 ea) [contains polysorbate 80]
Restasis MultiDose: 0.05% (1.5 mL [DSC], 5.5 mL) [contains polysorbate 80]
Verkazia: 0.1% (120 ea)
Generic: 0.05% (30 ea, 60 ea)
Solution, Ophthalmic:
Vevye: 0.1% (2 mL)
Solution, Ophthalmic [preservative free]:
Cequa: 0.09% (60 ea) [contains peg-40 hydrog castor oil(cremophor rh40)]
May be product dependent
Emulsion (cycloSPORINE Ophthalmic)
0.05% (per each): $12.27
Emulsion (Restasis MultiDose Ophthalmic)
0.05% (per mL): $140.87
Emulsion (Restasis Ophthalmic)
0.05% (per each): $12.91
Emulsion (Verkazia Ophthalmic)
0.1% (per each): $18.31
Solution (Cequa Ophthalmic)
0.09% (per each): $11.74
Solution (Vevye Ophthalmic)
0.1% (per mL): $462.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic:
Restasis: 0.05% (0.4 mL) [contains polysorbate 80]
Restasis MultiDose: 0.05% (5.5 mL) [contains polysorbate 80]
Verkazia: 0.1% (0.3 mL)
Generic: 0.05% (0.4 mL)
Solution, Ophthalmic:
Cequa: 0.09% (0.25 mL) [contains peg-40 hydrog castor oil(cremophor rh40)]
Ophthalmic: For ophthalmic use only. Administer immediately after opening single-use vial; discard remaining contents after use. Avoid contact of vial tip with skin or eye; remove contact lenses prior to administration; lenses may be inserted 15 minutes after instillation.
Emulsion 0.05% (eg, Restasis): Prior to use, invert vial several times to obtain a uniform emulsion. For multidose container, prime bottle for first-time use by squeezing 2 drops onto a tissue; do not let bottle tip touch tissue.
Emulsion 0.1% (eg, Verkazia): Supplied in a single-dose container containing adequate volume to treat both eyes; discard immediately after use. Shake prior to use. Separate other eye products by at least 10 minutes; administer 10 minutes before using any eye gel, ointment, or viscous eye drops.
Missed dose: Skip missed dose and administer next scheduled dose.
Ophthalmic: Administer single-use vials immediately after opening; discard remaining contents after use. Remove contact lenses prior to instillation of drops; may be reinserted 15 minutes after administration. To avoid contamination, do not touch bottle tip or vial tip to eyelids or other surfaces.
Cequa: May be used with lubricant eye drops; allow 15-minute interval between products.
Restasis: Prior to use, invert bottle or vial several times to obtain a uniform emulsion. Prime multidose bottle for first-time use by squeezing 2 drops onto a tissue (do not let bottle tip touch tissue). May be used with lubricant eye drops; allow 15-minute interval between products.
Verkazia: Gently shake vial several times prior to use. Separate other eye products by at least 10 minutes; administer 10 minutes before using any eye gel, ointment, or viscous eye drops.
Vevye: Separate other eye products by at least 15 minutes.
Hazardous agent (NIOSH 2016 [group 2]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
Cequa, Restasis: Store at 20°C to 25°C (68°F to 77°F).
Verkazia: Store at 20°C to 25°C (68°F to 77°F); do not freeze. Keep in aluminum pouch to protect from light and avoid evaporation.
Vevye: Store at 15°C to 25°C (59°F to 77°F); do not freeze or refrigerate.
Treatment of vernal keratoconjunctivitis (Ophthalmic emulsion 0.1% [eg, Verkazia]: FDA approved in ages ≥4 years and adults); increase tear production in patients with moderate to severe keratoconjunctivitis sicca-associated ocular inflammation (Ophthalmic emulsion 0.05% [eg, Restasis]: FDA approved in ages ≥16 years and adults; Ophthalmic solution 0.09% [eg, Cequa]: FDA approved in ages ≥18 years and adults); has also been used for the prevention of vernal keratoconjunctivitis.
CycloSPORINE may be confused with cycloPHOSphamide, Cyklokapron, cycloSERINE, voclosporin
Restasis may be confused with Refresh Celluvisc
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
None known.
There are no known significant interactions.
Serum concentrations are below the limit of detection (<0.1 ng/mL) following ophthalmic use; fetal exposure following ophthalmic administration is not expected.
Absorption: Cequa, Restasis: Serum concentrations were below the quantitation limit of 0.1 ng/mL; Verkazia: Maximum serum concentration 0.67 ng/mL.
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