Consumer medicine information

Cequa

Ciclosporin

BRAND INFORMATION

Brand name

Cequa

Active ingredient

Ciclosporin

Schedule

SUMMARY CMI

CEQUA™

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using CEQUA?

CEQUA contains the active ingredient ciclosporin. CEQUA is used to CEQUA is used to treat a condition known as 'keratoconjunctivitis sicca' which is also known as 'dry eye'.

For more information, see Section 1. Why am I using CEQUA? in the full CMI.

2. What should I know before I use CEQUA?

Do not use if you have ever had an allergic reaction to CEQUA or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CEQUA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CEQUA and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CEQUA?

One drop of CEQUA twice daily (about 12 hours apart) into each eye. You can use other artificial tears eye drops but you should wait at least 15 minutes after applying CEQUA.

More instructions can be found in Section 4. How do I use CEQUA? in the full CMI.

5. What should I know while using CEQUA?

Things you should do	Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you visit that you are using CEQUA.
Things you should not do	Do not stop taking your medicine or lower the dosage without checking with the doctor.
Things to be careful	If you are wearing contact lenses, remove them first before applying CEQUA. To avoid injury, be careful not to touch your eye with the tip of the ampoule.
Looking after your medicine	Keep your medicine in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using CEQUA? in the full CMI.

6. Are there any side effects?

Common side effects include pain, stinging or itchiness in your eye that persists after you add the drops to your eyes; persistent red or bloodshot eyes. Serious side effects include light sensitivity and/or blurred vision; Urinary Tract Infection: a change in the amount of urine passed or in the number of times you urinate, pain or a burning sensation when urinating, bloody, smelly or cloudy urine, pain in the pelvis.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

CEQUA™

Active ingredient(s): Ciclosporin

Consumer Medicine Information (CMI)

This leaflet provides important information about using CEQUA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CEQUA.

Where to find information in this leaflet:

1. Why am I using CEQUA?
2. What should I know before I use CEQUA?
3. What if I am taking other medicines?
4. How do I use CEQUA?
5. What should I know while using CEQUA?
6. Are there any side effects?
7. Product details

1. Why am I using CEQUA?

CEQUA contains the active ingredient ciclosporin. CEQUA belongs to a group of medicines called immunosuppressants. It works by reducing inflammation and increasing tear production so that your eyes are better lubricated.

CEQUA is used to treat a condition known as 'keratoconjunctivitis sicca' which is also known as 'dry eye'. When you have this condition, your tear glands do not produce enough tears and your eyes can become dry, red and irritated.

Your doctor will give you CEQUA if you have this condition and treatment with tear substitute medicines alone have not worked.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

CEQUA is not addictive.

CEQUA is available only with a doctor's prescription.

CEQUA is not expected to affect your ability to drive a car or operate machinery.

There is not enough information to recommend the use of this medicine for children under the age of 18 years.

2. What should I know before I use CEQUA?

Warnings

Do not use CEQUA if:

you are allergic to ciclosporin, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
you have an eye infection or think you may have an eye infection.
you have a cancer of the eye or around the eye.
the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor if you:

have allergies to any other medicines, foods, preservatives or dyes.
use contact lenses as you must not use CEQUA while you are wearing contact lenses. Your contact lenses must be removed before you use CEQUA and may be reinserted 15 minutes after using CEQUA.
are using artificial tears as you must not apply artificial tears at the same time as CEQUA. You can apply artificial tears 15 minutes after applying CEQUA.
are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using CEQUA.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant.

Possible effects of CEQUA on a developing baby have not been studied and are unknown.

Do not breast-feed if you are taking this medicine. Possible effects of CEQUA on a breast-feeding baby have not been studied and are unknown.

Children under the age of 18 years

Do not give this medicine to a child under the age of 18 years.

Safety and effectiveness in children younger than 18 years have not been established.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with CEQUA and affect how it works. These include:

Other eye drop

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CEQUA.

4. How do I use CEQUA?

How much to use

One drop of CEQUA twice daily (about 12 hours apart) into each eye. You can use other artificial tears eye drops but you should wait at least 15 minutes after applying CEQUA.

When to use CEQUA

As CEQUA should not be used more than twice a day and use should be about 12 hours apart, a morning and evening application is recommended.

Using it at the same times each day may help you remember when to use it.

It does not matter if you use this medicine before or after food.

How to use it

If you are wearing contact lenses, remove them first and wait at least 15 minutes after using CEQUA before reinserting.

Detach the ampoule from the connecting plastic strip and then twist the top off the plastic ampoule.

Tilt your head back and squeeze one drop into each eye.

To avoid injury, be careful not to touch your eye with the tip of the ampoule.

Immediately discard the ampoule after each use. Do not store any opened CEQUA ampoules.

How long to use it

Continue using your medicine for as long as your doctor tells you.

This medicine helps to control your condition but does not cure it.

If you forget to use CEQUA

If it is less than about 12 hours before your next dose, skip the dose you missed and use your next dose when you are meant to.

Do not use a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much CEQUA

If you think that you have used too much CEQUA, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CEQUA?

Things you should do

Call your doctor straight away if you:

become pregnant while taking CEQUA.
are about to have Blood tests.

Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you visit that you are using CEQUA.

Things you should not do

Do not use CEQUA to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen. If possible, your doctor will reduce the amount you use each day.
Do not store any opened CEQUA ampoules.

Things to be careful of

If you are wearing contact lenses, remove them first before applying CEQUA.

To avoid injury, be careful not to touch your eye with the tip of the ampoule.

Looking after your medicine

Keep your medicine in the foil pouch until you want to use it.

The ampoules may not keep well out of the foil pouch.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not freeze.

Do not store your medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
pain, stinging or itchiness in your eye that persists after you add the drops to your eyes persistent red or bloodshot eyes.	Speak to your doctor if you have any of these less serious side effects and they worry you.

If you suffer from damage to the clear layer at the front of your eye (the cornea), the phosphates in CEQUA may very rarely cause cloudy patches on your eye. Tell your doctor if you notice this.

Serious side effects

Serious side effects	What to do
light sensitivity and/or blurred vision. Urinary Tract Infection: a change in the amount of urine passed or in the number of times you urinate, pain or a burning sensation when urinating, bloody, smelly or cloudy urine, pain in the pelvis.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CEQUA contains

Active ingredient (main ingredient)	Ciclosporin 225 micrograms
Other ingredients (inactive ingredients)	PEG-40 hydrogenated castor oil octoxinol 40 povidone dibasic sodium phosphate monobasic sodium phosphate dihydrate sodium chloride water for injections sodium hydroxide or hydrochloric acid to adjust pH.

Do not take this medicine if you are allergic to any of these ingredients.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

This medicine is preservative free.

What CEQUA looks like

CEQUA is a clear, colourless liquid in soft plastic ampoules connected in cards of 5 ampoules. Two cards are enclosed in a sealed foil pouch and there are 6 foil pouches in a carton (60 ampoules per carton). (Aust R 313780).

Who distributes CEQUA

Sun Pharma ANZ Pty Ltd
ABN 17 110 871 826
12 Waterloo Road
Macquarie Park, Sydney NSW 2113
Australia
Email: [email protected]
Tel: 1800 726 229

This leaflet was prepared in December 2024

Published by MIMS March 2025

BRAND INFORMATION

Brand name

Cequa

Active ingredient

Ciclosporin

Schedule

1 Name of Medicine

Ciclosporin.

2 Qualitative and Quantitative Composition

Cequa contains ciclosporin 900 microgram/mL as the active ingredient. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops.
Cequa is a sterile, clear, colourless solution, practically free from visible particulates.

4 Clinical Particulars

4.1 Therapeutic Indications

Cequa is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient.

4.2 Dose and Method of Administration

For topical ophthalmic use.
Each Cequa ampoule is for single use in one patient only.
Instill one drop of Cequa twice daily (approximately 12 hours apart) into the affected eye(s).
Response to treatment should be reassessed at least every 6 months.
Cequa can be used concomitantly with artificial tears, allowing a 15-minute interval between products. Discard the ampoule immediately after using in both eyes.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients.
Active or suspected ocular or peri-ocular infection (see Section 4.4 Special Warnings and Precautions for Use).
Ocular or peri-ocular malignancies or premalignant conditions.

4.4 Special Warnings and Precautions for Use

Potential for eye injury and contamination.

To avoid the potential for eye injury and contamination, advise patients not to touch the ampoule tip to the eye or other surfaces.

Use with contact lenses.

Cequa should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Cequa ophthalmic solution.
Patients wearing contact lenses have not been studied.
Careful monitoring of patients with severe keratitis is recommended.

Infections.

Resolve existing or suspected ocular or peri-ocular infections before initiating Cequa treatment. If an infection occurs during treatment, Cequa should be temporarily withheld until the infection has been resolved.

Effects on the immune system.

Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defenses against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when Cequa is used for long periods.

Use in the elderly.

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Paediatric use.

The safety and efficacy of Cequa ophthalmic solution have not been established in paediatric patients below the age of 18.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Male and female fertility were unaffected by ciclosporin in rats at oral doses up to 15 mg/kg/day (more than 1500 times higher than the maximum recommended human ophthalmic dose, based on body surface area-adjusted doses for a 50 kg subject).
(Category C)
There are no adequate and well-controlled studies of Cequa administration in pregnant women. Studies in animals do not indicate a likely risk of embryofetal harm with ophthalmic use of ciclosporin. No embryofetal toxicity was observed with ciclosporin at oral doses of 17 mg/kg/day in the rat and 30 mg/kg/day in the rabbit, which are approximately 1800 and 6200 times higher than the maximum recommended human ophthalmic dose (based on body surface area-adjusted doses for a 50 kg subject). Embryo- and fetotoxicity; as increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations, were observed in animals at higher oral doses that were maternally toxic (30 mg/kg/day in rats and 100 mg/kg/day in rabbits). The offspring of pregnant rabbits given ciclosporin subcutaneously at 10 mg/kg/day had reduced numbers of nephrons and exhibited renal hypertrophy, systemic hypertension and progressive renal insufficiency postnatally.
Ciclosporin blood concentrations are low following topical ocular administration of Cequa (see Section 5.2 Pharmacokinetic Properties). There is no information regarding the presence of ciclosporin in human milk following topical administration or on the effects of Cequa on the breastfed infants and milk production. While systemically absorbed ciclosporin is excreted in milk, ciclosporin blood concentrations are low following topical ocular administration of Cequa (see Section 5.2 Pharmacokinetic Properties). Adverse effects in breast-fed infants are not expected given the low level of potential exposure but cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cequa and any potential adverse effects on the breast-fed child from ciclosporin.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

OTX‐101‐2014‐001 and OTX 101‐2016‐001 pooled data.

Safety data from the two 12-week pivotal studies, where a total of 524 subjects received OTX-101 0.09% (Safety Population), were pooled to provide increased sensitivity and precision. Most subjects were treated between 9 and < 13 weeks.
Subjects in the OTX-101 0.09% group had a higher incidence of any AE (38.7% versus 27.1%) and treatment-related AEs (25.2% versus 8.6%) compared with the Vehicle group. However, OTX-101 0.09% was generally well tolerated, with most AEs (approximately 70%), including ocular AEs, considered mild and did not require treatment. The most common AE was instillation site pain (OTX-101: 21.8%, Vehicle: 4.0%).
AEs of severe intensity (1.7% vs 0.8%), and events that led to interruption (0.8% vs 0.4%) or discontinuation (4.2% vs 1.7%) of study drug were low. Serious adverse events were uncommon (1.1% in both treatment groups). One subject randomized to OTX-101 0.09% in OTX-101-2016-001 died from an unknown cause, but not considered to be related to study drug. Table 1 presents treatment-emergent adverse events (TEAEs) reported in ≥ 2% of subjects in the Safety Population.

OTX‐101‐2016‐002 safety extension study.

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 OTX-101 0.09%. Of these, 129 subjects had previously received OTX-101 0.09% (Group 1) and another 129 subjects received Vehicle (Group 2) during the 12-week OTX-101-2016-001 study period. At completion of the extension study, a total of 225 subjects had more than 6 months exposure to OTX-101 0.09%, including 138 subjects who had ≥ 12 months of total exposure. The overall mean duration of exposure was 10.42 months.
An analysis of AEs in the full safety population for OTX-101-2016-002 did not reveal any new findings. There were no changes to the SAE profile. Instillation site pain remained the most commonly reported AE. It was reported at a higher incidence, as expected, in subjects who had received Vehicle prior to being switched to OTX-101 0.09%.
Besides instillation site pain (22.9%), conjunctival hyperemia (10.1%), and punctate keratitis (6.2%) were the most commonly reported TEAEs. 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. Table 2 presents the TEAEs reported in ≥ 2% of total subjects.

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Post‐marketing experience.

Infections and infestations.

Urinary tract infection.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ciclosporin is a calcineurin inhibitor immunosuppressant agent when administered systemically. It is able to inhibit the activation of transcription factors required for T-cell activation and inflammatory cytokine production. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical administration of ciclosporin is thought to act as a partial immunomodulator. The exact mechanism of action in treating keratoconjunctivitis sicca is not known.

Clinical trials.

Two multicentre, randomised, vehicle-controlled clinical studies treated 1,048 patients with keratoconjunctivitis sicca (OTX-101-2014-001 and OTX-101-2016-001). 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. Table 3 presents data from the studies.

5.2 Pharmacokinetic Properties

Absorption.

Blood concentrations of ciclosporin after twice daily topical ocular administration of Cequa into each eye of healthy subjects for up to 7 days, and once on Day 8, were either not detectable or were marginally above the lower limit of assay quantitation of 0.100 nanogram/mL (range 0.101 to 0.195 nanogram/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple doses.

5.3 Preclinical Safety Data

Genotoxicity.

Ciclosporin was not genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. An in vitro sister chromatid exchange (SCE) assay using human lymphocytes gave indications of a positive effect for ciclosporin at high concentrations.

Carcinogenicity.

Systemic carcinogenicity studies were carried out in mice and rats. A 78-week mouse study, at oral doses of 1, 4, and 16 mg/kg/day, revealed a trend for increased incidences of lymphomas at the highest dose studied. In another study with ARK mice treated with ciclosporin at 150 mg/kg in the diet, ciclosporin accelerated the development of lymphomas.
In a 24-month rat study, conducted at oral doses of 0.5, 2, and 8 mg/kg/day, no significant increase in tumour incidence was observed. Adjusted for body surface area, the highest doses without tumourigenic effect in the mouse and rat are approximately 210 and 830 times higher than the maximum recommended ophthalmic dose of ciclosporin provided by Cequa therapy.

6 Pharmaceutical Particulars

6.1 List of Excipients

PEG-40 hydrogenated castor oil, octoxinol 40, povidone, dibasic sodium phosphate, monobasic sodium phosphate dihydrate, sodium chloride, water for injections and sodium hydroxide or hydrochloric acid to adjust pH.

6.2 Incompatibilities

Cequa should not be administered to patients while they are wearing contact lenses (see Section 4.4 Special Warnings and Precautions for Use).

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze. Store the ampoules in the original foil pouch. Protect from light.

6.5 Nature and Contents of Container

Cequa ophthalmic solution is packaged in single-use LDPE ampoules. Each ampoule contains 0.25 mL of the solution.
Cequa ampoules are packaged in cartons of 10 or 60 ampoules: 10 ampoules (2 cards of 5 ampoules) are packaged in a polyfoil aluminum pouch; 1 pouch (10s) or 6 pouches (60s) are packaged in the cartons. The carton of 10 ampoules is a sample pack only.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material can be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Ciclosporin is a white powder that is insoluble in water and freely soluble in ethanol.

Chemical structure.

Mol. Formula: C₆₂H₁₁₁N₁₁O₁₂.
Mol. Wt.: 1202.6.

CAS number.

59865-13-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

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Ciclosporin

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