Conjunctivitis (Pink Eye) Treatments

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Generic Name

CycloSPORINE

Brand Names

CEQUA, Gengraf, Neoral, Restasis, Restasis MultiDose, Sandimmune, Verkazia, VEVYE

FDA approval date: November 14, 1983

Classification: Calcineurin Inhibitor Immunosuppressant

Form: Injection, Emulsion, Capsule, Solution

What is CEQUA (CycloSPORINE)?

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca . CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca .

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Brand Information

CEQUA (cyclosporine)

1INDICATIONS AND USAGE

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (

2DOSAGE AND ADMINISTRATION

Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. CEQUA can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard the vial immediately after using in both eyes. (

3DOSAGE FORMS AND STRENGTHS

Ophthalmic solution containing cyclosporine 0.9 mg/mL (

4CONTRAINDICATIONS

None. (

5DESCRIPTION

CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:

Structural Formula

Formula: C

Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains:

Active: cyclosporine 0.09%
Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.

6CLINICAL STUDIES

Two multicenter, randomized, adequate and well-controlled clinical studies treated 1,048 patients with keratoconjunctivitis sicca (NCT # 02254265 and NCT # 02688556). In both studies, compared to vehicle at Day 84, there was a statistically significant (p<0.01) higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 17% of CEQUA-treated patients versus approximately 9% of vehicle-treated patients.

7HOW SUPPLIED/STORAGE AND HANDLING

CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial

contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a

polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of

60 vials must be dispensed intact.

60 Single-Use Vials 0.25 mL each - NDC 47335-506-96

Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.

8PATIENT COUNSELING INFORMATION

Handling the Vial

Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may

contaminate the solution. Advise patients also not to touch the vial tip to their eye to avoid the

potential for injury to the eye

Use with Contact Lenses

CEQUA should not be administered while wearing contact lenses. Patients with decreased tear

production typically should not wear contact lenses. Advise patients that if contact lenses are

worn, they should be removed prior to the administration of the solution. Lenses may be

reinserted 15 minutes following administration of CEQUA ophthalmic solution

and Precautions (5.2)].

Administration

Advise patients that the solution from one individual single-use vial is to be used immediately

after opening for administration to one or both eyes, and the remaining contents should be

discarded immediately after administration.

Rx Only

Manufactured for: Sun Pharmaceutical Industries Limited

By: Laboratoire Unither

1 rue de l’Arquerie

50200 Coutances

France

Cyclosporine (active ingred.) Product of Czech Republic.

Product of France

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

07/2022

uspi-CEQUA-sol-00004