Lucentis Dosage/Direction for Use

Dosage Regimen: Single-use vial (adults and preterm infants) for intravitreal use only. Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection.
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Lucentis in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should not be shorter than one month.
The recommended dose for Lucentis in preterm infants is 0.2 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.02 mL. Treatment of ROP is initiated with a single dose and can be given bilaterally on the same day. Further treatment may be administered if there are signs of disease activity. The interval between two doses injected into the same eye should not be shorter than one month.
General target population: Treatment of wet AMD, DME, moderately severe to severe NPDR or PDR, macular edema secondary to RVO, CNV or CNV secondary to PM: Treatment in adults is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity.
Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity as assessed by visual acuity and/or anatomic parameters.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
If patients are being treated according to a treat-and-extend regimen, for example, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by two weeks at a time for wet AMD and central RVO (CRVO), or by one month at a time for DME and branch RVO (BRVO). If disease activity recurs, the treatment interval should be shortened accordingly.
The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. In the treatment of visual impairment due to CNV secondary to PM, many patients may only need one or two injections during the first year, while some patients may need more frequent treatment (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Lucentis and laser photocoagulation in DME and branch RVO: Lucentis has been used concomitantly with laser photocoagulation in clinical studies (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have received previous laser photocoagulation.
Treatment of ROP in preterm infants: Treatment in preterm infants is initiated with a single injection. Further treatment may be administered if there are signs of disease activity.
Special populations: Renal impairment: Dose adjustment is not needed in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Lucentis has not been studied in patients with hepatic impairment. However, as systemic exposure is negligible, no special measures are considered necessary in this population.
Pediatric patients (below 18 years): Lucentis is not recommended for use in children and adolescents due to insufficient data on safety and efficacy in these sub-populations. Limited data on adolescent patients aged 12 to 17 years with visual impairment due to CNV is available (see Pharmacology: Pharmacodynamics: Clinical Studies: Pediatric patients under Actions).
Geriatric patients (65 years or above): No dose adjustment is required in the elderly.
Method of administration: As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Sterile paracentesis equipment should be available as a precautionary measure. The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see Contraindications). Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
For information on preparation of Lucentis, see Instructions for Use and Handling under Cautions for Usage.
In adults the injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the center of the globe. The injection volume of 0.05 mL is then delivered; the scleral site should be rotated for subsequent injections.
In preterm infants, the injection needle should be inserted 1.0 to 2.0 mm posterior to the limbus with the needle pointing towards the optic nerve. The injection volume of 0.02 mL is then delivered.