"The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter "...
Retisert Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Retisert (fluocinolone acetonide intravitreal implant) is a corticosteroid used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The implant slowly releases the drug into the eye over a period of approximately 30 months. Retisert will not treat an eye infection. Common side effects include swelling of the eyelids; eye irritation; dry or watery eyes; itching, mild skin rash; feeling something is in your eye; headache, dizziness; runny or stuffy nose, sore throat, fever, cough; nausea, vomiting; or back pain, joint or muscle pain.
The Retisert implant contains one tablet of 0.59 mg of fluocinolone acetonide. Retisert is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months. Retisert may interact with oral, nasal, or inhaled steroids. Tell your doctor all medications and supplements you use. It is unknown if Retisert ophthalmic implant is harmful to a fetus if you receive the implant while you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is unknown if the drug from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Retisert (fluocinolone acetonide intravitreal implant) 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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Retisert in Detail - Patient Information: Side Effects
For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- sudden vision loss, eye pain or redness;
- bleeding, oozing, or crusting of your eyes;
- cloudiness in the pupils or iris of your eyes;
- seeing flashes of light, halos around lights, or "floaters" in your vision; or
- tunnel vision, problems with peripheral (side) vision.
Less serious side effects may include:
- swelling of the eyelids;
- mild eye irritation;
- dry or watery eyes;
- itching, mild skin rash;
- the feeling that something is in your eye;
- headache, dizziness;
- runny or stuffy nose, sore throat, fever, cough;
- nausea, vomiting; or
- back pain, joint or muscle pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Retisert (Fluocinolone Acetonide Intravitreal Implant)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Retisert FDA Prescribing Information: Side Effects
Clinical Trials Experience - Ocular Events
The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter controlled clinical trials. Patients were randomized to dosage regimens of 0.59 mg or 2.1 mg implants.
The most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain. These events occurred in approximately 50 - 90% of patients. Cataract includes aggravated cataract, and posterior capsular opacification. Procedural complications includes post-op complication, post-op wound complication, post-op wound site erythema, and wound dehiscense.
Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery. IOP lowering medications to lower intraocular pressure were required in approximately 77% of patients; filtering surgeries were required to control intraocular pressure in 37% of patients. Ocular adverse events occurring in approximately 10 - 40% of patients in decreasing order of incidence were ocular/conjunctival hyperemia, reduced visual acuity, glaucoma, conjunctival hemorrhage, blurred vision, abnormal sensation in the eye, eye irritation, maculopathy, vitreous floaters, hypotony, pruritus, ptosis, increased tearing, vitreous hemorrhage, dry eye, eyelid edema, macula edema and visual disturbance.
Ocular adverse events occurring in approximately 5 - 9% of patients in decreasing order of incidence were eye discharge, photophobia, blepharitis, corneal edema, iris adhesions, choroidal detachment, diplopia, eye swelling, retinal detachment, photopsia, retinal hemorrhage and hyphema.
Clinical Trials Experience - Non-Ocular Events
The most frequently reported non-ocular adverse event was headache (33%). Other non-ocular adverse events occurring in approximately 5-20% of patients in decreasing order of incidence were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, upper respiratory tract infection, influenza, vomiting, nausea, cough, back pain, limb pain, and rash.
Read the entire FDA prescribing information for Retisert (Fluocinolone Acetonide Intravitreal Implant)
Additional Retisert Information
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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