cyclosporine (Restasis)

Restasis ophthalmic emulsion is a prescription eye drop that helps patients increase their eyes' natural ability to produce tears. It is used to treat a type of chronic dry eye condition caused by inflammation. Cyclosporine, the medicine in Restasis, is also available in oral and injectable formulations that are used to treat various conditions including treatment or prevention of rejection of transplanted organs, psoriasis, and rheumatoid arthritis. Following oral administration or injection, cyclosporine is absorbed in the blood stream and works systemically to suppress the body's immune system. However, cyclosporine eye drop emulsion is thought to work differently. Restasis is believed to work locally in the eye as a partial modulator of the immune system. Tear production is thought to be decreased when lymphocytes, a type of white blood cell of the immune system, die and accumulate in the tear glands. Restasis reverses this condition, increasing tear production. Restasis does not produce its effect immediately. An increase in tear production may not be noticed until 3 to 6 months after starting treatment. Restasis ophthalmic emulsion was approved by the FDA in January, 2003.

Restasis

GENERIC AVAILABLE: No

Yes

The most common side effect of cyclosporine ophthalmic emulsion is a temporary burning sensation in the eye. Other side effects include:

• eye redness,
• discharge,
• watery eyes,
• eye pain,
• foreign body sensation,
• itching,
• stinging, and
• blurred vision.

One drop should be instilled in each eye twice daily. Patients may use Restasis with artificial tears or over-the-counter eye lubricants, allowing a 15 minute interval between products.

Restasis should not be used while wearing contact lenses. Patients with chronic dry eye are generally advised not to wear contact lenses. If contact lenses are worn, they should be removed before applying Restasis. Lenses may be inserted 15 minutes after applying Restasis.

The safety and effectiveness of Restasis has not been established in children below the age of 16.

The effectiveness of Restasis may be affected if administered with other eye drops. Patients using other eye drops should consult with their eye doctor for advice. Patients may use Restasis with artificial tears or over-the-counter eye lubricants, allowing a 15 minute interval between products.

Due to the lack of conclusive safety data, Restasis should be used in pregnancy only if clearly needed. Restasis is classified as FDA pregnancy risk category C (it caused harm in studies with animals, but use during pregnancy in humans has not been adequately evaluated).

It is not known if cyclosporine is excreted into breast milk following administration into the eye. Although blood levels were undetectable following ophthalmic administration, Restasis should be used cautiously during nursing.

What preparations of cyclosporine-ophthalmic are available?

Ophthalmic emulsion (eye drops): 0.5 mg/ml cyclosporine. Restasis is supplied in a sterile, preservative-free single-use vial.

How should I keep cyclosporine-ophthalmic stored?

Restasis should be stored at room temperature, between 15 C to 25 C (59 F to 77 F).