May 29, 2016
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Jetrea

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Jetrea




Jetrea Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/22/2016

Jetrea (ocriplasmin) is an antiplasmin inhibitor injection that works to dissolve a protein found in the eye, used to treat the eye condition symptomatic vitreomacular adhesion (SVA). Side effects of Jetrea include eye floaters, eye pain, blurred vision, bleeding within the outside lining of the eye (conjunctival hemorrhage), flashes of light (photopsia), and visual impairment. After receiving the Jetrea injection, patients may experience inflammation or infections of the eye, as well as hemorrhage and increased pressure within the eye.

The recommended dose of Jetrea is 0.125 mg injected into the eye as a single dose. Symptomatic vitreomacular adhesion may progress, resulting in decreases in vision. Patients experiencing decreases in vision should report their symptoms to their doctors immediately. Jetrea may interact with other drugs. Tell your doctor all medications you use. It is not known if the use of Jetrea in pregnant women may result in harm to the fetus. It is not known if Jetrea passes into breast milk. Doctors should use caution when giving Jetrea to a nursing woman.

Our Jetrea (ocriplasmin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Jetrea FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

Approximately 800 patients have been treated with an intravitreal injection of JETREA. Of these, 465 patients received an intravitreal injection of ocriplasmin 0.125 mg (187 patients received vehicle) in the 2 vehicle-controlled studies (Study 1 and Study 2).

The most common adverse reactions (incidence 5% -20% listed in descending order of frequency) in the vehicle-controlled clinical studies were: vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, macular hole, reduced visual acuity, visual impairment, and retinal edema.

Less common adverse reactions observed in the studies at a frequency of < 5% in patients treated with JETREA included macular edema, increased intraocular pressure, anterior chamber cell, photophobia, vitreous detachment, ocular discomfort, iritis, cataract, dry eye, metamorphopsia, pupillary reflex impaired, conjunctival hyperemia, retinal degeneration, and visual symptoms perceived in the contralateral eye. .

Dyschromatopsia was reported in 2% of patients injected with JETREA, with the majority of cases reported from two uncontrolled clinical studies. In approximately half of these dyschromatopsia cases there were also electroretinographic (ERG) changes reported (a-and b-wave amplitude decrease).

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity for this product has not been evaluated.

Postmarketing Experience

Night blindness has been identified during post-approval use of JETREA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Jetrea (Ocriplasmin Injection)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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