Pronunciation:

sye-kloe-SPOR-een

Brand Names:

• Cequa
• Restasis
• Restasis Multidose
• Verkazia
• Vevye

Dosage Forms:

• Emulsion
• Solution

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Calcineurin Inhibitor

Uses of This Medicine:

Cyclosporine eye drops are used to increase tear production in patients who have a certain eye condition (eg, keratoconjunctivitis sicca). It is also used to treat vernal keratoconjunctivitis (allergic eye condition) and signs and symptoms of dry eye disease. This medicine belongs to a class of medicines known as immunosuppressants.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Cequa™ and Vevye® in children or Restasis ™ in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Verkazia® in children 4 years of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Cequa™, Restasis ™, or Vevye® in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of Verkazia® in the elderly. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Take this medicine only as directed by your eye doctor (ophthalmologist). Do not use more of it, do not use it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may use Verkazia® for at least 10 minutes before using other eye products (eg, eye ointment, gel, or other thick eye drops).

If you or your child are wearing contact lenses, remove them while you are using this medicine. You can reinsert your contacts 15 minutes after you put the medicine in your eyes. Talk to your eye doctor about this if you have questions.

To use Cequa™ or Restasis ™:

• First, wash your hands.
• Rotate the vial gently back and forth before use. Do not shake the vial.
• Tilt the head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye).
• This medicine can be used with lubricant eye drops (eg, artificial tears). After putting in your artificial tears, you must wait 15 minutes before putting the cyclosporine eye drops into your eyes.

To use Verkazia®:

• First, wash your hands.
• Gently shake the vial.
• Tilt the head back and look up, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine onto your eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Blink a few times so that the medicine spreads across your eye.
• Press the corner of your eye closest to your nose and gently close your eyelids for 2 minutes.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye).
• Wait at least 10 minutes before you use other eye products (eg, eye ointment, gel, or other thick eye drops).

To use Vevye®:

• Wash your hands with soap and water before and after you use this medicine.
• Tilt the head back and look up, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine onto your eye.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.
• Wait at least 15 minutes before you use other eye drops.

You might not use all of the medicine in each single-dose vial. Use each single-dose vial only one time. Do not save an open single-dose vial.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For dry eye disease:
  • For ophthalmic solution dosage form (eye drops):
    • Adults—Instill one drop into the affected eye(s) 2 times a day (every 12 hours).
    • Children—Use and dose must be determined by your doctor.
• To increase tear production:
  • For ophthalmic emulsion dosage form (eye drops):
    • Adults and children 16 years of age and older—Instill one drop into the affected eye(s) 2 times a day (every 12 hours).
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
  • For ophthalmic solution dosage form (eye drops):
    • Adults—Instill one drop into the affected eye(s) 2 times a day (every 12 hours).
    • Children—Use and dose must be determined by your doctor.
• To treat vernal keratoconjunctivitis:
  • For ophthalmic emulsion dosage form (eye drops):
    • Adults and children 4 years of age and older—Instill one drop into the affected eye(s) 4 times a day (morning, noon, afternoon, and evening).
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you miss a dose of Verkazia®, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your eye doctor check your or your child's eyes at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If your or your child's symptoms do not improve or if they become worse, check with your doctor.

This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive or do anything else that could be dangerous until you know how this medicine affects you.

While applying this medicine, your eyes will probably sting or burn for a short time. This is to be expected.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chills

cough

difficult, burning, or painful urination

ear congestion

fever

headache

loss of voice

lower back or side pain

runny or stuffy nose

sneezing

sore throat

trouble breathing

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, pain, itching, or other discomfort of the eye

pain upon instillation of drops

redness of the white part of your eyes or inside of your eyelids

Less common

Blurred vision

clear or yellow fluid from the eye

difficulty with reading

eye irritation

feeling of having something in the eye

halos around lights

headache

itching skin

redness, swelling, or itching of the eyelid

sticky or matted eyelashes

stinging

watery eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.