Active Ingredient: Aflibercept
Aflibercept is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Intravitreal, 0.4 milligrams aflibercept, one dose.
Regimen B, in case that there is absent response to treatment
Intravitreal, 0.4 milligrams aflibercept, one dose, over the duration of 1 to 6 months. Afterwards, intravitreal, 0.4 milligrams aflibercept, one dose.
The recommended dose is a single intravitreal injection of 0.4 mg aflibercept.
Treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In total, up to 2 injections per eye may be administered within 6 months of treatment initiation if there are signs of disease activity. The treatment interval between the 2 doses injected into the same eye should be at least 4 weeks.
Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections. In general, adequate anaesthesia and asepsis, including topical broad spectrum microbicide (e.g. povidone iodine applied to the periocular skin, eyelid and ocular surface), have to be ensured. Surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) are recommended.
The injection needle should be inserted into the eye 1.0 to 2.0 mm from the limbus with the needle pointing towards the optic nerve.
Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available.
Patients with ROP should be observed by healthcare professionals for any signs suggestive of endophthalmitis (e.g. redness/irritation of the eye, ocular discharge, lid swelling, photophobia).
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