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CEQUA is a brand name for Cyclosporine (also known as Ciclosporin), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CEQUA (cyclosporine ophthalmic solution 0.09% w/v) is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye). 1.1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of CEQUA has not been established in pediatric patients; therefore, Health Canada…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations For topical ophthalmic use. Each CEQUA vial is for single use in one patient only. There are no special dosing considerations which need to be taken into account prior to initiating therapy with CEQUA. 2 Recommended Dose and Dosage Adjustment Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye.
The dose should not exceed two drops (administered 12 hours apart) in the affected eye(s) daily. Limited data from clinical studies exists for long-term administration of CEQUA (up to 12 months). It is expected that use of the product will continue long-term.
3 Pediatrics). 4 Administration 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.
Advise patients to wash their hands before each use and not to touch the tip of the vial to their eye or any other surface, in order to avoid eye injury or contamination of the solution (see 7 WARNINGS AND PRECAUTIONS, Potential for Eye Injury and Contamination).
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. CEQUA can be used concomitantly with artificial tears, allowing a 15-minute interval between products. 5 Missed Dose If a dose of this medication is missed, treatment should be continued on the next instillation as normal.
Doses should not be doubled. Patients should be advised not to instill more than two drops in the affected eye(s) daily.
1 Adverse Reaction Overview The most common adverse reaction reported in subjects following the use of CEQUA was pain on instillation of drops (22%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
OTX-101-2014-001 and OTX 101-2016-001 Pooled Safety Data The primary assessment of safety is derived from two multicenter, randomized, double - masked, 12-week, vehicle-controlled trials of similar design in subjects with keratoconjunctivitis sicca.
Study OTX-101-2016-001 was a pivotal Phase 3 study and study OTX- 101-2014-001 was a supportive Phase 2b/3 study. e. 09% w/v). The majority of the treated subjects were female (83%) and the mean age was 59 years. 7% vs. 2% vs. 6%) compared with the Vehicle group.
However, CEQUA was generally well tolerated with most adverse events considered mild and did not require treatment. The most common adverse events (AEs) reported in greater than 1% of subjects (Table 2) were instillation site pain (22%) and conjunctival hyperemia (6%).
The most common non-ocular AEs (≥ 1% of subjects in either group) were headache and urinary tract infection. 7% vs. 8% vs. 2% vs. 7%) of study drug were low. 1% in both treatment groups). One subject randomized to CEQUA in study OTX-101-2016-001 died from an unknown cause, but not considered to be related to study drug.
e. OTX-101-2016- 002. All 258 subjects from the Phase 3 study OTX-101-2016-001 who subsequently participated in the open-label 40-week OTX-101-2016-002 extension study were treated with CEQUA. Of these, 129 subjects had previously received CEQUA (Group 1) and another 129 subjects had received Vehicle (Group 2) during the 12-week OTX-101-2016-001 study period.
, Immune 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................
4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
5 5 OVERDOSAGE ............................................................................................................. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS ..................................................................................
CEQUA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with active or suspected ocular or peri-ocular infections. • Patients with ocular or peri-ocular malignancies or premalignant conditions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cyclosporine in Canada.
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At completion of the extension study, a total of 225 subjects had more than 6 months exposure to CEQUA including 138 subjects who had ≥12 months of total exposure. 42 months. An analysis of adverse events in the full safety population for study OTX-101-2016-002 did not reveal any new findings.
There were no changes to the serious adverse event profile. Instillation site pain remained the most commonly reported adverse event. It was reported at a higher incidence, as expected, in subjects who had received Vehicle prior to being switched to CEQUA.
2%) were the most commonly reported treatment-emergent adverse events (Table 3). Punctate keratitis was reported by more subjects in Group 1, but it was considered unrelated to treatment in all cases but one, and the difference is attributed to the natural variability of the presentation of KCS.
4%) reporting severe intensity. 2) Group 1 subjects continued with CEQUA in the Safety Extension Study. Group 2 subjects began CEQUA treatment in the Safety Extension Study. 3 Less Common Clinical Trial Adverse Reactions Eye disorders: Conjunctival edema, eye pain, lacrimation increased, vision blurred General disorders and administrative site conditions: Instillation site lacrimation, […]
1 Special Populations ............................................................................................ 1 Pregnant Women ......................................................................................... 2 Breast-feeding..............................................................................................
3 Pediatrics ..................................................................................................... 4 Geriatrics ..................................................................................................... 8 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions ..................................................
5 Post-Market Adverse Reactions........................................................................ 11 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview..............................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 12 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics ....................................................................................... 13 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
13 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 13 PART II: SCIENTIFIC INFORMATION ......................................................................................
15 13 PHARMACEUTICAL INFORMATION............................................................................ 15 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 16 Keratoconjunctivitis sicca (KCS).................................................................................. 16 16 NON-CLINICAL TOXICOLOGY .....................................................................................
18 PATIENT MEDICATION INFORMATION ................................................................................. 09% w/v) is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye).
1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of CEQUA has not been established in pediatric patients; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
2 CONTRAINDICATIONS CEQUA is contraindicated in: • Patients who are hypersensitive to this drug or […]