GNH USA

Europe — EMA

Iluvien

GNH USA supplies Iluvien (Fluocinolone Acetonide), a corticosteroid for diabetic macular edema and chronic non‑infectious posterior uveitis.

Fluocinolone Acetonide

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What is Fluocinolone Acetonide?

Fluocinolone Acetonide, the active ingredient in Iluvien, is a corticosteroid presented as a 0.19 mg intravitreal sustained‑release implant for intravitreal injection use. It delivers a continuous anti‑inflammatory effect to treat diabetic macular edema and chronic non‑infectious posterior uveitis in adult patients, reducing retinal swelling and preserving vision over several months.

GNH USA supplies Iluvien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing regulatory‑approved product documentation and logistics support for global distribution and ensuring compliance with local import requirements.

What is Fluocinolone Acetonide used for?

Iluvien (fluocinolone acetonide) is used to manage ocular inflammatory conditions that cause retinal swelling.

- Diabetic macular edema (DME): reduces fluid accumulation in the macula and helps stabilize or improve visual acuity. - Chronic non‑infectious posterior uveitis: suppresses intra‑ocular inflammation and limits disease progression. - Uveitic macular edema: provides sustained anti‑inflammatory therapy to control swelling associated with posterior uveitis.

What are the side effects of Fluocinolone Acetonide?

Iluvien may cause a range of ocular adverse reactions, most of which are related to its corticosteroid activity.

Common Side Effects: - Increased intraocular pressure: may require topical pressure‑lowering medication. - Cataract formation: accelerated lens opacity, especially in phakic eyes. - Ocular discomfort or pain at the injection site. - Vitreous floaters or visual disturbances. - Conjunctival hemorrhage following the procedure. - Transient blurred vision.

Serious or Rare Side Effects: - Endophthalmitis: intra‑ocular infection requiring urgent treatment. - Retinal detachment or tear. - Persistent or severe inflammation despite therapy. - Optic nerve damage leading to vision loss. - Implant migration or dislocation. - Systemic corticosteroid effects (rare) such as hyperglycemia.

What precautions apply to Fluocinolone Acetonide?

Prior to Iluvien implantation, clinicians should evaluate patient‑specific risk factors and follow appropriate monitoring.

- Patient selection: assess baseline intraocular pressure and glaucoma risk. - Monitoring: schedule regular IOP checks after implantation. - Contraindications: avoid in eyes with active infection or uncontrolled inflammation. - Surgical technique: ensure sterile intravitreal injection to minimize infection risk. - Pregnancy and lactation: use only if potential benefit outweighs potential risk. - Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

What does Fluocinolone Acetonide interact with?

Iluvien may interact with other ocular or systemic agents, influencing safety or efficacy.

Major Interactions (Avoid): - Concurrent intravitreal corticosteroids: additive risk of ocular hypertension and cataract. - Systemic potent CYP3A4 inducers (e.g., rifampin): may reduce local steroid exposure.

Moderate Interactions (Monitor Closely): - Topical ocular NSAIDs: increased risk of corneal complications. - Systemic anticoagulants: heightened chance of intra‑ocular hemorrhage during injection. - Antifungal azoles (e.g., ketoconazole): may increase local steroid levels, requiring IOP monitoring.

Frequently asked questions

What conditions is Iluvien used to treat?+
Iluvien is indicated for the treatment of diabetic macular edema and chronic non‑infectious posterior uveitis. In both conditions it provides a sustained anti‑inflammatory effect that helps reduce retinal swelling and preserve visual function.
How does fluocinolone acetonide work in the eye?+
Fluocinolone acetonide binds to glucocorticoid receptors in ocular tissues, modulating gene transcription to suppress inflammatory cytokines and mediators. This reduces vascular leakage, stabilizes the blood‑retinal barrier, and limits leukocyte infiltration, thereby decreasing macular edema and intra‑ocular inflammation.
What is the usual dose of Iluvien?+
The dose of Iluvien is determined by the prescribing ophthalmologist. The product is supplied as a 0.19 mg intravitreal sustained‑release implant, and the clinician decides the appropriate implantation schedule based on the patient’s condition.
Is Iluvien safe to use during pregnancy or breastfeeding?+
Safety of Iluvien in pregnancy or lactation has not been established. It should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision must be made by the treating physician.
How do I order Iluvien from GNH USA?+
To order Iluvien, submit an enquiry on the product page at gnh-usa.com indicating the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.
How does Iluvien compare with other treatments for diabetic macular edema?+
Iluvien offers a sustained‑release corticosteroid option that can provide therapeutic effect for up to 36 months with a single implantation, reducing the need for frequent injections. Alternative therapies include anti‑VEGF agents that require monthly or bimonthly dosing, and other intravitreal steroids with shorter duration of action.
What are the storage requirements for Iluvien?+
Iluvien should be stored at 2‑8 °C in a refrigerator. Keep the implant in its original packaging, protect it from light, and do not freeze or shake the product to maintain its integrity.
How is Iluvien administered?+
Iluvien is administered by a trained ophthalmologist via a sterile intravitreal injection. The 0.19 mg implant is placed into the vitreous cavity of the eye, where it releases fluocinolone acetonide slowly over several months.
What are the most serious risks associated with Iluvien?+
Serious risks include elevated intraocular pressure that may lead to glaucoma, cataract formation, endophthalmitis (eye infection), retinal detachment, and rare systemic corticosteroid effects. Patients should be monitored regularly for these complications.
Who should not receive Iluvien?+
Iluvien is contraindicated in patients with active ocular infection, uncontrolled glaucoma, or known hypersensitivity to fluocinolone acetonide or any component of the implant. Caution is also advised for patients with a history of steroid‑responsive intraocular pressure elevation.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Fluocinolone Acetonide
Route
Intravitreal Use
Manufacturer
Alimera Sciences Europe Limited
Origin
EU

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