Embedded Files
Pharmacologic Category
Calcineurin Inhibitor; Immunosuppressant Agent
Dosing: Adult
Keratoconjunctivitis sicca: Ophthalmic: Instill 1 drop in each eye twice daily (approximately 12 hours apart).
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Pediatric
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 0.05% (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 of 54 pediatric patients (mean age: 9.6 years; range: 5 to 14 years); after 3 months of therapy, improved symptoms were observed, no adverse effects were reported (Keklikci 2008). A case series in 6 patients (6 to 14 years) treated with 1 drop twice daily or 4 times daily was also shown to improve symptoms; in 4 patients cyclosporine was weaned after 6 months (n=1) or 12 months (n=3) of therapy; in 3 other patients, therapy was still ongoing at the time of publication (Ozcan 2007). 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 US (Vichyanond 2013).
Ophthalmic emulsion 0.1% (Verkazia [Canadian product]): Children ≥4 years and Adolescents: Ophthalmic: Instill 1 drop 4 times daily; after clinical response established, may consider reduced daily dose to 1 drop twice daily; discontinue treatment after resolution of signs and symptoms; safety and efficacy has not been evaluated past 12 months of therapy (Leonardi 2019).
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 (Lambiase 2011).
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
Use: Labeled Indications
Keratoconjunctivitis sicca: Increase tear production when suppressed tear production is presumed to be due to keratoconjunctivitis sicca-associated ocular inflammation (in patients not already using topical anti-inflammatory drugs or punctal plugs)
* See Uses in AHFS Essentials for additional information.
Comparative Efficacy
Administration: Ophthalmic
Administer immediately after opening single-use vial; discard remaining contents after use. Remove contact lenses prior to instillation of drops; may be reinserted 15 minutes after administration. May be used with lubricant eye drops; allow 15-minute interval between products. To avoid contamination, do not touch bottle tip or vial tip to eyelids or other surfaces.
Emulsion 0.05%: 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).
Administration: Pediatric
Ophthalmic: For ophthalmic use only. Avoid contact of vial tip with skin or eye; remove contact lenses prior to administration; lenses may be inserted 15 minutes after instillation. May be used with artificial tears; separate administration by at least 15 minutes. Single-dose containers should be discarded after each use.
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% (Canadian product [Verkazia]): Supplied in a single-dose container containing adequate volume to treat both eyes. Single-dose containers should be discarded after each use. Shake prior to use; after instillation, apply gentle pressure to lacrimal sac during and immediately following instillation for 2 minutes.
Hazardous Drugs Handling Considerations
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).
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F).
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to help some patients make more tears.
Frequently reported side effects of this drug
• Eye pain
• Eye redness
• Burning
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Vision changes
• Severe eye irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
High alert medication:
Contraindications
Hypersensitivity to cyclosporine or any component of the formulation.
Warnings/Precautions
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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Evaluate the patient's or caregiver's ability to safely administer the correct dose of ophthalmic medication.
Pregnancy Considerations
Adverse events were not observed following the use of oral cyclosporine in animal reproduction studies. Serum concentrations are below the limit of detection (<0.1 ng/mL) following ophthalmic use; fetal exposure following ophthalmic administration is not expected.
Breast-Feeding Considerations
Cyclosporine is present in breast milk following oral administration (refer to the Cyclosporine [Systemic] monograph for additional information). Serum concentrations are below the limit of detection (<0.1 ng/mL) following ophthalmic use. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
>10%: Ophthalmic: Eye pain (1% to 22%), burning sensation of eyes (17%)
1% to 10%:
Central nervous system: Foreign body sensation of eye (1% to 5%), headache (1% to 5%)
Genitourinary: Urinary tract infection (1% to 5%)
Ophthalmic: Conjunctival hyperemia (1% to 6%), blepharitis (1% to 5%), blurred vision (1% to 5%), epiphora (1% to 5%), eye discharge (1% to 5%), eye irritation (1% to 5%), eye pruritus (1% to 5%), stinging of eyes (1% to 5%), visual disturbance (1% to 5%)
<1%, postmarketing and/or case reports: Hypersensitivity reaction
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Advanced Practitioners Physical Assessment/Monitoring
Assess for vision changes, eye pain or irritation, and hypersensitivity reactions.
Nursing Physical Assessment/Monitoring
Educate patient on proper administration technique. Monitor for and have patient report visual changes or signs of eye irritation.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic [preservative free]:
Restasis: 0.05% (30 ea, 60 ea) [contains polysorbate 80]
Restasis MultiDose: 0.05% (1.5 mL, 5.5 mL) [contains polysorbate 80]
Solution, Ophthalmic [preservative free]:
Cequa: 0.09% (60 ea) [contains cremophor el]
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic:
Restasis: 0.05% (0.4 mL, 1 ea) [contains polysorbate 80]
Restasis MultiDose: 0.05% (1.5 mL, 5.5 mL) [contains polysorbate 80]
Verkazia: 0.1% (0.3 mL)
Generic: 0.05% (0.4 mL)
Anatomic Therapeutic Chemical (ATC) Classification
- S01XA18
Generic Available (US)
No
Pricing: US
Emulsion (Restasis MultiDose Ophthalmic)
0.05% (per mL): $127.77
Emulsion (Restasis Ophthalmic)
0.05% (per each): $11.71
Solution (Cequa Ophthalmic)
0.09% (per each): $10.14
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.
Pharmacodynamics/Kinetics
Absorption: Serum concentrations were below the quantitation limit of 0.1 ng/mL
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Related Information
Index Terms
Cequa; Ciclosporin; CsA; CyA; Cyclosporin A
FDA Approval Date
December 23, 2002
References
<800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.
Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597.[PubMed 3960626]
Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm[PubMed 6423951]
Cequa (cyclosporine) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; September 2019.
Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]
Keklikci U, Soker SI, Sakalar YB, Unlu K, Ozekinci S, Tunik S. Efficacy of topical cyclosporin A 0.05% in conjunctival impression cytology specimens and clinical findings of severe vernal keratoconjunctivitis in children. Jpn J Ophthalmol. 2008;52(5):357-362.[PubMed 18991035]
Lambiase A, Leonardi A, Sacchetti M, Deligianni V, Sposato S, Bonini S. Topical cyclosporine prevents seasonal recurrences of vernal keratoconjunctivitis in a randomized, double-masked, controlled 2-year study. J Allergy Clin Immunol. 2011;128(4):896-897.[PubMed 21868078]
Leonardi A, Doan S, Amrane M, et al. A randomized, controlled trial of cyclosporine A cationic emulsion in pediatric vernal keratoconjunctivitis: the VEKTIS study. Ophthalmology. 2019;126(5):671-681.[PubMed 30593775]
Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]
Ozcan AA, Ersoz TR, Dulger E. Management of severe allergic conjunctivitis with topical cyclosporin a 0.05% eyedrops. Cornea. 2007;26(9):1035-1038.[PubMed 17893529]
Restasis (cyclosporine) [prescribing information]. Irvine, CA: Allergan Inc; received July 20, 2017.
Restasis Multidose (cyclosporine) [prescribing information]. Irvine, CA: Allergan Inc; October 2016.
Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]
US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.
Verkazia (cyclosporine) [product monograph]. Emeryville, CA: Santen Incorporated; December 2018.
Vichyanond P, Kosrirukvongs P. Use of cyclosporine A and tacrolimus in treatment of vernal keratoconjunctivitis. Curr Allergy Asthma Rep. 2013;13(3):308-314.[PubMed 23625179]
Brand Names: International
Clacier (KR); Cyclomocond (EG); Cyclomune (IN); Cyporin (BD, LK); Ikervis (ES, GB, HK, MY, PH, SG, TH); Modusik-A Ofteno (CN, PE); Papilock (JP); Restasis (AR, BB, BR, CN, CO, GR, HK, IL, KR, LB, MY, PE, PH, SI, TH, TW, UA, VE, VN); Restor (BD); Sporium (BD)
Last Updated 2/14/20
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