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1 X 0.23 ml
Pre-filled Syringe (solution for injection)
1 X 0.165 ml
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Adults: 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.
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.
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. 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.
Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO: There is some experience of Lucentis administered concomitantly with laser photocoagulation. 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.
Preterm infants: 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.
Hepatic impairment: Lucentis has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.
Renal impairment: Dose adjustment is not needed in patients with renal impairment.
Elderly: No dose adjustment is required in the elderly.
Paediatric population: Lucentis is not indicated for use in children and adolescents.
Method of administration
Single-use pre-filled syringe for intravitreal use only.
The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg ranibizumab).
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.
Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection.
Pre-filled syringe and Vial
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) 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. 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.
Adults: 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.
Each pre-filled syringe should only be used for the treatment of a single eye.
Paediatric population: 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.
Treatment of neovascular (wet) age-related macular degeneration (AMD). Treatment of adult patients with visual impairment due to diabetic macular edema (DME).
Treatment of visual impairment due to macular edema secondary to retinal vein occulsion (RVO).
Treatment of visual impairment due to choroidal neovascularization (CNV).
Lucentis 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 3+) or AP-ROP (aggressive posterior ROP) disease.
Hypersensitivity to the active substance or to any of the excipients.
Patients with active or suspected ocular or periocular infections.
Patients with active severe intraocular inflammation.
Treatment with Lucentis is for intravitreal injection only.
Intravitreal injection-related reactions: Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Proper aseptic injection techniques must always be used when administering Lucentis. In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Intraocular pressure increases: Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis. Sustained IOP increases have also been reported. Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Bilateral treatment: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.
Immunogenicity: There is a potential for immunogenicity with Lucentis.
Concomitant use of other anti-VEGF (vascular endothelial growth factor): Lucentis should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
Withholding Lucentis in adults: The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; an intraocular pressure of ≥30 mmHg; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days.
Retinal pigment epithelial tear: Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD, include a large and/or high pigment epithelial retinal detachment. When initiating Lucentis therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Rhegmatogenous retinal detachment or macular holes: Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Systemic effects following intravitreal use: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors. There is a potential risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF (vascular endothelial growth factor) inhibitors.
See prescribing information for full details.
The majority of adverse reactions reported following administration of Lucentis are related to the intravitreal injection procedure. The most frequently reported ocular adverse reactions following injection of Lucentis are: eye pain, ocular hyperaemia, increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye and eye pruritus.
The most frequently reported non-ocular adverse reactions are headache, nasopharyngitis and arthralgia.
Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract.
See prescribing information for full details.
No formal interaction studies have been performed.
For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis in wet AMD and PM, see section 5.1 at the attached doctor’s leaflet.
For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1 at the attached doctor’s leaflet.
In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with Lucentis was not affected by concomitant treatment with thiazolidinediones.
Paediatric population: No interaction studies have been performed.
Pregnancy and Lactation
Pregnancy: For ranibizumab no clinical data on exposed pregnancies are available.
Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development. The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic. Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus. For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child.
Lactation: It is unknown whether Lucentis is excreted in human milk. Breast-feeding is not recommended during the use of Lucentis.
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.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage: Vial: 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.
Pre-filled syringe: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in its sealed tray in the carton in order to protect from light.