GNH USA

Europe — EMA

Iluvien

GNH USA supplies Iluvien (Fluocinolone Acetonide), a corticosteroid for chronic diabetic macular edema and 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 use. It treats chronic diabetic macular edema and non‑infectious posterior uveitis in patients whose disease has not responded adequately to other therapies.

GNH USA supplies Iluvien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Fluocinolone Acetonide used for?

Iluvien is used in ophthalmology to manage chronic retinal conditions characterized by inflammation and fluid accumulation.

- Chronic diabetic macular edema: reduces retinal swelling and improves visual acuity in patients unresponsive to other treatments. - Non‑infectious posterior uveitis: decreases intra‑ocular inflammation and helps preserve vision in chronic posterior segment inflammation.

What are the side effects of Fluocinolone Acetonide?

Iluvien may cause ocular and systemic adverse reactions that vary in frequency and severity.

Common Side Effects: - Increased intraocular pressure: may require topical or systemic pressure‑lowering therapy. - Cataract progression: accelerated lens opacity especially in phakic eyes. - Ocular pain or discomfort after injection. - Vitreous floaters or transient visual disturbances. - Conjunctival hemorrhage at the injection site.

Serious or Rare Side Effects: - Endophthalmitis: intra‑ocular infection requiring urgent treatment. - Retinal detachment or tear. - Implant migration into the anterior chamber. - Persistent or severe intra‑ocular inflammation. - Optic nerve damage or vision loss.

What precautions apply to Fluocinolone Acetonide?

Prior to Iluvien implantation, clinicians should assess ocular health and monitor for potential complications.

- Intraocular pressure monitoring: check baseline and follow‑up pressures regularly. - Cataract evaluation: assess lens status before and during treatment. - Avoid in active ocular infection: postpone implantation until infection resolves. - Caution in patients with uncontrolled glaucoma: risk of pressure spikes may outweigh benefits. - Hypersensitivity screening: do not use if known allergy to fluocinolone acetonide or implant components. - Store below 25°C: keep in the original packaging, protect from moisture and light.

What does Fluocinolone Acetonide interact with?

Iluvien may interact with other ocular or systemic therapies; awareness helps mitigate risks.

Major Interactions (Avoid): - Systemic corticosteroids: may increase systemic glucocorticoid exposure and related adverse effects. - Potent immunosuppressants (e.g., biologics): heightened risk of intra‑ocular infection. - Recent intra‑ocular surgery (within 6 weeks): may impair wound healing.

Moderate Interactions (Monitor Closely): - Topical ocular steroids: cumulative intra‑ocular pressure elevation. - Anti‑glaucoma medications: may require dose adjustment if pressure rises. - Anti‑VEGF agents: potential additive effect on retinal fluid control. - Non‑steroidal anti‑inflammatory eye drops: monitor for delayed healing.

Frequently asked questions

What conditions is Iluvien used to treat?+
Iluvien is indicated for the treatment of chronic diabetic macular edema that has not responded adequately to other therapies, and for non‑infectious posterior uveitis. In both conditions it helps reduce retinal swelling and control intra‑ocular inflammation, aiming to preserve or improve visual function.
How does fluocinolone acetonide work in the eye?+
Fluocinolone acetonide binds to glucocorticoid receptors inside ocular cells, modulating gene transcription. This suppresses inflammatory cytokines, prostaglandins, and other mediators, leading to reduced vascular permeability, decreased fluid leakage, and control of inflammatory processes within the retina and posterior segment.
What is the usual dose of Iluvien?+
Iluvien is supplied as a single‑use 0.19 mg intravitreal implant. The prescribing ophthalmologist determines the need for implantation and may consider re‑implantation after approximately 36 months, based on the patient’s response and disease activity.
Is Iluvien safe to use during pregnancy or breastfeeding?+
The pregnancy category for fluocinolone acetonide intravitreal implants is unknown. Use is only recommended if the potential benefit justifies any possible risk to the fetus. Limited data exist for breastfeeding; the decision should be made in consultation with a healthcare professional.
How do I order Iluvien from GNH USA?+
To order Iluvien, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The team then replies with pricing, availability, shipping details (including any cold‑chain requirements), and import documentation.
How does Iluvien compare with other treatments for the same conditions?+
The main alternative intravitreal corticosteroid is the dexamethasone implant (Ozurdex), which releases drug over a shorter period and may require more frequent re‑injection. Anti‑VEGF agents are also used for diabetic macular edema but act on a different pathway. Iluvien provides a longer‑lasting release (up to 36 months), reducing the need for repeated procedures.
What are the storage requirements for Iluvien?+
Iluvien should be stored below 25 °C in its original packaging. Protect the implant from moisture and direct light. Do not freeze or expose it to extreme temperatures, as this could compromise the sustained‑release matrix.
How is Iluvien administered?+
Iluvien is implanted by a qualified ophthalmic surgeon using a sterile intravitreal injection technique. The implant is placed into the vitreous cavity through a pars plana approach under local or topical anesthesia, typically in an outpatient setting.
What are the most serious risks associated with Iluvien?+
Serious risks include elevated intra‑ocular pressure that may lead to glaucoma, cataract formation, endophthalmitis (intra‑ocular infection), retinal detachment, and rare cases of implant migration. Patients should be monitored regularly for these complications, and any signs of infection or vision loss require immediate medical attention.
Who should not receive Iluvien?+
Iluvien is contraindicated in patients with active ocular infection, known hypersensitivity to fluocinolone acetonide or implant components, uncontrolled glaucoma, or those who cannot undergo intravitreal surgery. Caution is also advised for individuals with a history of severe steroid‑induced intra‑ocular pressure spikes.
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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