Fluocinolone Intravitreal Implant

Fluocinolone Intravitreal Implant is a prescription medication used for the treatment of Uveitis and Diabetic Macular Edema. 

• Fluocinolone Intravitreal Implant is available under the following different brand names: Retisert, Iluvien, Yutiq

Common side effects of Fluocinolone Intravitreal Implants include:

• Mild eye redness or pain,
• Feeling like something is in the eye,
• Headache, and
• Your eyes may be more sensitive to light.

Serious side effects of Fluocinolone Intravitreal Implant include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Blurred vision,
• Tunnel vision,
• Problems with peripheral (side) vision,
• Eye redness,
• Eye pain or swelling,
• Seeing halos around lights,
• Bleeding, oozing, or crusting of the eyes,
• Flashes of light or “floaters” in your vision, and
• Cloudiness in the pupil or iris (colored part of the eyes)

Rare side effects of Fluocinolone Intravitreal Implant include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intravitreal insert

• 0.18 mg/insert (Yutiq)
• 0.19 mg/insert (Iluvien)
• 0.59 mg/insert (Retisert)

Uveitis

Adult dosage

• Retisert
  • Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over approximately 30 months
  • Replace when evidence of uveitis recurs.
• Yutiq
  • Releases at an initial rate of 0.25 mcg/day over approximately 36 months
  • Pediatric dosage
• Uveitis (Retisert)
• Below 12 years: Safety and efficacy not established.
• Above 12 years
  • Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over approximately 30 months
  • Replace when evidence of uveitis recurs.

Diabetic Macular Edema

Adult dosage

• Iluvien: Releases at an initial rate of 0.25 mcg/day over approximately 36 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fluocinolone Intravitreal Implant has no noted severe interactions with any other drugs.
• Fluocinolone Intravitreal Implant has no noted serious interactions with any other drugs.
• Fluocinolone Intravitreal Implant has no noted moderate interactions with any other drugs.
• Fluocinolone Intravitreal Implant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to product or components
• Active viral, bacterial, mycobacterial, and fungal ocular or periocular infection
• Iluvien only: Glaucoma with cup-to-disc ratios above 0.8

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluocinolone Intravitreal Implant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluocinolone Intravitreal Implant?”

Cautions

• Nearly all phakic patients are expected to develop cataracts and require cataract surgery.
• Monitor for endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments.
• Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma with damage to the optic nerve, defects in visual acuity, and fields of vision.
• Periodically monitor for the integrity of the implant
• Risk for implant migration into the anterior chamber if the posterior capsule of the lens is absent or has a tear.
• Risk of postoperative infections in both eyes may be reduced by unilateral implantation.
• May mask or exacerbate the existing infection.
• Corticosteroids are not recommended with a history of ocular herpes simplex, and potential for viral reactivation.

Pregnancy and Lactation

• Adequate and well-controlled studies have not been conducted on pregnant women to inform a drug-associated risk.
• Animal reproduction studies have not been conducted.
• Unknown whether fetal harm occurs when administered to a pregnant woman or can affect reproduction capacity.
• Corticosteroids are teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
• Consider potential benefit justifies the potential risk to the fetus.
• Lactation
  • Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production
  • Clinical or nonclinical lactation studies have not been conducted.
  • Unknown if distributed in human breast milk.
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.