Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Lucentis is indicated in adults for:
Lucentis is indicated in preterm infants for:
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 be at least four weeks.
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 i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment. 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 anatomical 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 on 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. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1). 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.
There is no experience of concomitant administration of Lucentis and verteporfin.
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 total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity. Most patients (78%) in the clinical study received one injection 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.
Lucentis has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.
Dose adjustment is not needed in patients with renal impairment (see section 5.2).
No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.
The safety and efficacy of Lucentis in children and adolescents below 18 years of age for indications other than retinopathy of prematurity have not been established. Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.
Single-use vial for intravitreal use only.
Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml for adults and 0.02 ml for preterm infants), a portion of the volume contained in the vial must be discarded prior to administration.
Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
For information on preparation of Lucentis, see section 6.6.
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) and the availability of sterile paracentesis (if required). The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.
In adults the injection needle should be inserted 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. The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
For treatment of preterm infants the low volume high accuracy syringe provided together with an injection needle (30G x 1⁄2′′) in the VISISURE kit should be used (see also section 6.6).
In preterm infants, the injection needle should be inserted into the eye 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.
Cases of accidental overdose have been reported from the clinical studies in wet AMD and post- marketing data. Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain. If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Shelf life: 3 years.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (25°C) for up to 24 hours.
Vial-only pack: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Vial + filter needle pack: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution and 1 blunt filter needle (18G x 11⁄2′′, 1.2 mm x 40 mm, 5 μm).
Not all pack sizes may be marketed.
The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the packaging seal remains intact.
For preparation and intravitreal injection the following medical devices for single use are needed:
These medical devices are not included within this pack.
The vial and filter needle are for single use only. Re-use may lead to infection or other illness/injury. All components are sterile. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact.
For preparation and intravitreal injection the following medical devices for single use are needed:
To prepare Lucentis for intravitreal administration to adults, please adhere to the following instructions:
After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
To prepare Lucentis for intravitreal administration to preterm infants, please adhere to the instructions for use included in the VISISURE kit.
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