CYCLOSPORINE
Generic: CYCLOSPORINE
Basic Information
Manufacturer
Saptalis Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
ff4dc2fc-667a-489a-b798-8d11cddfe716
Indications & Usage
1 IN DICATIONS AND USAGE Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Cyclosporine is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
( 1 )
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Cyclosporine is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
( 1 )
Adverse Reactions
6 A DVERSE R EACTIONS The following serious adverse reactions are described elsewhere in the labeling: Potential for Eye Injury and Contamination [ see Warnings and Precautions ( 5.1 ) ] The most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%).
Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of cyclosporine ophthalmic emulsion.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%).
Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of cyclosporine ophthalmic emulsion.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).