Ranibizumab

Must be administered by a qualified ophthalmologist experienced in intravitreal injections. In wet AMD, DME, PDR and RVO, initially three or more consecutive monthly injections may be needed. Treat-and-extend: once maximum visual acuity is achieved and/or no signs of disease activity, treatment intervals can be extended stepwise — by no more than two weeks at a time for wet AMD, and by up to one month at a time for DME; for PDR and RVO intervals may also be gradually extended but there are insufficient data to conclude on their length. If disease activity recurs, shorten the interval accordingly. CNV: treatment determined individually per patient — some patients may need only one injection during the first 12 months, others a monthly injection; for CNV secondary to pathologic myopia many patients may need only one or two injections during the first year. If given on the same day as laser photocoagulation (DME, macular oedema secondary to BRVO), administer at least 30 minutes after the laser. Discontinue if visual and anatomic parameters indicate the patient is not benefiting from continued treatment. WITHHOLD the dose (and do not resume before the next scheduled treatment) if: BCVA decrease of >=30 letters vs the last assessment; intraocular pressure >=30 mmHg; a retinal break; a subretinal haemorrhage involving the centre of the fovea or >=50% of the total lesion area; intraocular surgery performed or planned within the previous or next 28 days. Do not administer concurrently with other anti-VEGF medicinal products (systemic or ocular). PAEDIATRIC (fixed dose, NOT per-kg — recorded here rather than in paedDose): in PRETERM INFANTS for retinopathy of prematurity the recommended dose is 0.2 mg given as an intravitreal injection (injection volume 0.02 ml); treatment is initiated with a single injection per eye and may be given bilaterally on the same day; in total up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity; administration of more than three injections per eye has not been studied; the interval between two doses injected into the same eye should be at least four weeks; use the low-volume high-accuracy syringe with a 30G x 1/2 inch needle (VISISURE kit), inserting the needle 1.0 to 2.0 mm posterior to the limbus pointing towards the optic nerve. For indications OTHER than retinopathy of prematurity, safety and efficacy in children and adolescents below 18 years have not been established (data in adolescents aged 12-17 with visual impairment due to CNV exist but no posology recommendation can be made). Adults: insert the needle 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe; use a different scleral site for subsequent injections. Elderly: no dose adjustment required (limited experience above 75 years with DME). Hepatic impairment: not studied, but no special considerations are needed.