Ocriplasmin Intraocular

In the U.S.

• Jetrea

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Proteolytic Enzyme

Ocriplasmin injection is used to treat symptomatic vitreomacular adhesion. Symptomatic vitreomacular adhesion is an eye condition related to aging that may lead to blurring of vision or blindness.

ocriplasmin is only administered by or under the supervision of your doctor.

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 ocriplasmin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ocriplasmin 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ocriplasmin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ocriplasmin injection in the elderly.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

The presence of other medical problems may affect the use of ocriplasmin. Make sure you tell your doctor if you have any other medical problems, especially:

• Detached retina (eye disorder) or
• Dyschromatopsia (color vision disorder) or
• Eye infection or
• Glaucoma (increased pressure in the eye) or
• Lens subluxation (partial dislocation of the eye lens)—Use with caution. May make these conditions worse.

Your eye doctor will want to check your progress at regular visits, especially during the first few days after you receive ocriplasmin.

Serious eye problems may occur with ocriplasmin. Check with your eye doctor right away if your eye becomes red, sensitive to light, or painful, or if you have a change in vision, or feel increased pressure in the eye several days after the injection.

ocriplasmin may cause temporary blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not able to see well. If this symptom persists, have your eyes checked by an eye doctor.

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 or nurse immediately if any of the following side effects occur:

• Bloody eyes
• blurred vision or other change in vision
• decreased vision
• eye pain
• redness of the eye
• seeing flashes or sparks of light
• sensitivity of the eye to light
• tearing

• Change in color vision
• difficulty seeing at night
• eye discomfort
• loss of vision
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• throbbing pain

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:

• Dry eyes

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.