Lucentis 10mg/ml Solution for Injection

INJECTION, SOLUTION

**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage regimen** Single-use vial (adults and preterm infants) or single-use pre-filled syringe (adults only) 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 (0.05 mL) or 0.3mg (0.03mL) given monthly as a single intravitreal injection. The interval between two doses injected into the same eye should not be shorter than one month. The recommended maximal dose (0.5mg) should not be exceeded. One eye only should be injected on each occasion and post-injection monitoring is recommended (see section WARNINGS AND PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The treat-and-extend regimen and the treatment of PDR is only pertaining to the 0.5mg dose. The recommended dose for Lucentis in preterm infants is 0.2 mg given as an intravitreal injection. This corresponds to an injection volume of 0.02 mL. In preterm infants treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In the clinical study (RAINBOW), up to three ranibizumab injections per eye (i.e. 6 injections in total per subject) were allowed within six months of treatment initiation if there were signs of disease activity. Most patients (57 (78%.1)) in the clinical study received a total of one injection per eye. Ten (13.7%) patients received a total of two injections per eye and two (2.7%) received a total of three injections per eye. The 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. The pre-filled syringe can only deliver a dose of 0.5mg (0.05mL) due to a fixed dose mark. The single-use vial must be used when a dose of 0.3mg (0.03mL) or 0.2mg (0.02mL) is required. **General target population** **Treatment of wet AMD, DME, 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. In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed. 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. If, in the physician’s opinion, visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, Lucentis should be discontinued. 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, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended, by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude the length of these intervals. 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. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. 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, (see section CLINICAL STUDIES – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Lucentis and laser photocoagulation in DME and branch RVO** Lucentis has been used concomitantly with laser photocoagulation in clinical studies (see section CLINICAL STUDIES – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. **Lucentis and Verteporfin photodynamic therapy in CNV secondary to PM** There is no experience of concomitant administration of Lucentis and Verteporfin. Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. **Treatment of ROP in preterm infants** Treatment in preterm infants is initiated with a single injection per eye and may be given bilaterally on the same day. **Special populations** **Renal impairment** Dose adjustment is not needed in patients with renal impairment (see section CLINICAL PHARMACOLOGY/PHARMACOKINETICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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 of age)** The safety and efficacy of Lucentis in children and adolescents for indications other than retinopathy of prematurity have not been established. Limited data on adolescent patients aged 12 to 17 years with visual impairment due to CNV is available (see section CLINICAL STUDIES, Pediatric patients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Geriatric patients (65 years of age and 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 should be carefully evaluated for hypersensitivity reactions prior to performing the intravitreal procedure (see section 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 more information on preparation of Lucentis, see section INSTRUCTIONS FOR USE AND HANDLING – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. 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 centre of the globe. The injection volume of 0.03mL or 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. Lucentis contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.