Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lucentis 10 mg/ml solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ranibizumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Lucentis is Lucentis is a solution which is injected into the eye. Lucentis belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab. What Lucentis is used for Lucentis is used in adults to treat several eye diseases causing vision impairment. These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by: Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV. Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)). How Lucentis works Lucentis specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Lucentis can block its actions and prevent this abnormal growth and swelling. In these diseases, Lucentis can help to stabilise and in many cases improve your vision. 2.
What you need to know before you take it
Lucentis
You must not receive Lucentis If you are allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6). If you have an infection in or around your eye. If you have pain or redness (severe intraocular inflammation) in your eye. 1
Warnings and precautions Talk to your doctor before you are given Lucentis. Lucentis is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur after Lucentis treatment. It is important to identify and treat such an infection or retinal detachment as soon as possible. Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light. In some patients the eye pressure may increase for a short period directly after the injection. This is something you may not notice, therefore your doctor may monitor this after each injection. Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding). This information will be taken into account to evaluate if Lucentis is the appropriate treatment for you. Please see section 4 ("Possible side effects") for more detailed information on side effects that could occur during Lucentis therapy. Children and adolescents (below 18 years of age) The use of Lucentis in children and adolescents has not been established and is therefore not recommended. Other medicines and Lucentis Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Lucentis. There is no experience of using Lucentis in pregnant women. Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Lucentis. Small amounts of Lucentis may pass into breast milk, therefore Lucentis is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Lucentis treatment. Driving and using machines After Lucentis treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves. 3.
How to take it
Lucentis is administered as a single injection into your eye by your eye doctor under a local anaesthetic. The usual dose of an injection is 0.05 ml (which contains 0.5 mg of active substance). The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume 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. The interval between two doses injected into the same eye should be at least four weeks. All injections will be administered by your eye doctor. Before the injection, your doctor will wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection. 2
The treatment is started with one injection of Lucentis per month. Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment. Detailed instructions for use are given at the end of the leaflet under "How to prepare and administer Lucentis". Elderly (age 65 years and over) Lucentis can be used for people of 65 years of age and over without dose adjustment. Before stopping Lucentis treatment If you are considering stopping Lucentis treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Lucentis. If you have any further questions on the use of this medicine, ask your doctor. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects associated with the administration of Lucentis are either due to the medicine itself or the injection procedure and mostly affect the eye. The most serious side effects are described below: Common serious side effects (may affect up to 1 in 10 people): Detachment or tear of the layer in the back of the eye (retinal detachment or tear), resulting in flashes of light with floaters progressing to a temporary loss of sight, or a clouding of the lens (cataract). Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye. The symptoms you might experience are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light. Please tell your doctor immediately if you develop any of these side effects. The most frequently reported side effects are described below: Very common side effects (may affect more than 1 in 10 people) Visual side effects include: Inflammation of the eye, bleeding in the back of the eye (retinal bleeding), visual disturbances, eye pain, small particles or spots in your vision (floaters), bloodshot eye, eye irritation, a feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margins, dry eye, redness or itching of the eye and increased eye pressure. Non-visual side effects include: Sore throat, nasal congestion, runny nose, headache and joint pain. Other side effects which may occur following Lucentis treatment are described below: Common side effects Visual side effects include: Decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of eye), small marks on the surface of the eye, blurred vision, bleeding at the site of injection, bleeding in the eye, discharge from the eye with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, swelling of the eyelid, eyelid pain. Non-visual side effects include: Urinary tract infection, low red blood cells count (with symptoms such as tiredness, breathlessness, dizziness, pale skin), anxiety, cough, nausea, allergic reactions like rash, hives, itching and skin reddening.
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Uncommon side effects Visual side effects include: Inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 5.
How to store it
Lucentis
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Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Prior to use, the sealed tray may be kept at room temperature (25°C) for up to 24 hours. Keep the pre-filled syringe in its unopened tray in the carton in order to protect from light. Do not use any pack that is damaged.
6.
Contents of the pack and other information
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What Lucentis contains The active substance is ranibizumab. Each ml contains 10 mg ranibizumab. One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab. The other ingredients are α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections. What Lucentis looks like and contents of the pack Lucentis is a solution for injection in a pre-filled syringe. The pre-filled syringe contains 0.165 ml of a sterile, clear, colourless to pale brownish-yellow aqueous solution. The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume 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. Pack size of one pre-filled syringe, packed in a sealed tray. The pre-filled syringe is for single use only. Marketing Authorisation Holder and Manufacturer Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane London, W12 7FQ United Kingdom For any information about this medicine, please contact the local representative of the Marketing
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Authorisation Holder: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 This leaflet was last revised in 01/2025 Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
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The following information is intended for healthcare professionals only: Please also refer to section 3 "How Lucentis is given". How to prepare and administer Lucentis Single-use pre-filled syringe for intravitreal use only Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. In wet AMD, in CNV, in PDR and in visual impairment due to DME or to macular oedema secondary to RVO the recommended dose for Lucentis 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 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 anatomical 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. Lucentis and laser photocoagulation in DME and 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. 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. 6
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. The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The sterility of the pre-filled syringe cannot be guaranteed unless the tray remains sealed. Do not use the pre-filled syringe if the solution is discoloured, cloudy or contains particles. 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). For the intravitreal injection, a 30G x 1⁄2′′ sterile injection needle should be used. To prepare Lucentis for intravitreal administration, please adhere to the instructions for use: Introduction
Read all the instructions carefully before using the pre-filled syringe. The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The opening of the sealed tray and all subsequent steps should be done under aseptic conditions. Note: The dose must be set to 0.05 ml.
Pre-filled syringe description
Syringe cap
0.05 ml dose mark
Luer lock
Rubber stopper
Finger grip
Plunger rod
Figure 1 Prepare
1. 2.
Check syringe
3. 4.
Make sure that the pack contains: a sterile pre-filled syringe in a sealed tray. Peel the lid off the syringe tray and, using aseptic technique, carefully remove the syringe. Check that: the syringe cap is not detached from the Luer lock. the syringe is not damaged. the solution looks clear, colourless to pale brownish-yellow and does not contain any particles. If any of the above is not true, discard the pre-filled syringe and use a new one.
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Remove syringe cap
5. 6.
Snap off (do not turn or twist) the syringe cap (see Figure 2). Dispose of the syringe cap (see Figure 3).
Figure 2
Figure 3 Attach needle
7.
Attach a 30G x 1⁄2′′ sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 4). 8. Carefully remove the needle cap by pulling it straight off (see Figure 5). Note: Do not wipe the needle at any time.
Figure 4
8
Figure 5
Dislodge air bubbles
9. Hold the syringe upright. 10. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).
Figure 6 Set dose
Inject
11. Hold the syringe at eye level and carefully push the plunger until the edge below the dome of the rubber stopper is aligned with the dose mark (see Figure 7). This will expel the air and the excess solution and set the dose to 0.05 ml. Note: The plunger rod is not attached to the rubber stopper – this is to prevent air being drawn into the syringe.
Figure 7 The injection procedure should be carried out under aseptic conditions. 12. 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. 13. Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 ml. 14. A different scleral site should be used for subsequent injections. 15. 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.
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Frequently asked questions about Lucentis 10 mg/ml solution for injection in pre-filled syringe
How do I take Lucentis 10 mg/ml solution for injection in pre-filled syringe?
Lucentis 10 mg/ml solution for injection in pre-filled syringe comes as injection containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Lucentis 10 mg/ml solution for injection in pre-filled syringe?
The active substance in Lucentis 10 mg/ml solution for injection in pre-filled syringe is ranibizumab.
Are there equivalent medicines to Lucentis 10 mg/ml solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Byooviz 10 mg/ml solution for injection, Byooviz 10 mg/ml solution for injection in pre-filled syringe, Lucentis 10 mg/ml solution for injection. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lucentis 10 mg/ml solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lucentis 10 mg/ml solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ranibizumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Lucentis is indicated in adults for:
• The treatment of neovascular (wet) age-related macular degeneration (AMD)
• The treatment of visual impairment due to diabetic macular oedema (DME)
• The treatment of proliferative diabetic retinopathy (PDR)
• The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
• The treatment of visual impairment due to choroidal neovascularisation (CNV)
4.2. Posology and method of administration
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Posology
The recommended dose for Lucentis 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 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).
Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO
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.
Lucentis and verteporfin photodynamic therapy in CNV secondary to PM
There is no experience of concomitant administration of Lucentis and verteporfin.
Special populations
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 (see section 5.2).
Elderly
No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.
Paediatric population
The safety and efficacy of Lucentis in children and adolescents below 18 years of age 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.
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).
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 (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.
For information on preparation of Lucentis, see section 6.6.
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.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with active or suspected ocular or periocular infections.
Patients with active severe intraocular inflammation.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Intravitreal injection-related reactions
Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8). 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. Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
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 identified (see section 4.8). Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Patients should be informed of the symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8).
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. Since there is a potential for an increased systemic exposure in subjects with DME, an increased risk for developing hypersensitivity in this patient population cannot be excluded. Patients should also be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
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
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 and potentially also other forms of CNV, include a large and/or high pigment epithelial retinal detachment. When initiating ranibizumab 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.
Populations with limited data
There is only limited experience in the treatment of subjects with DME due to type I diabetes. Lucentis has not been studied in patients who have previously received intravitreal injections, in patients with active systemic infections, or in patients with concurrent eye conditions such as retinal detachment or macular hole. There is limited experience of treatment with Lucentis in diabetic patients with an HbA1c over 108 mmol/mol (12%) and no experience in patients with uncontrolled hypertension. This lack of information should be considered by the physician when treating such patients.
There are insufficient data to conclude on the effect of Lucentis in patients with RVO presenting irreversible ischaemic visual function loss.
In patients with PM, there are limited data on the effect of Lucentis in patients who have previously undergone unsuccessful verteporfin photodynamic therapy (vPDT) treatment. Also, while a consistent effect was observed in subjects with subfoveal and juxtafoveal lesions, there are insufficient data to conclude on the effect of Lucentis in PM subjects with extrafoveal lesions.
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 are limited data on safety in the treatment of DME, macular oedema due to RVO and CNV secondary to PM patients with prior history of stroke or transient ischaemic attacks. Caution should be exercised when treating such patients (see section 4.8).
4.5. Interaction with other medicinal products and other forms of interaction
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.
For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1.
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.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females
Women of childbearing potential should use effective contraception during treatment.
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 (see section 5.3). 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.
Breast-feeding
Based on very limited data, ranibizumab may be excreted in human milk at low levels. The effect of ranibizumab on a breast-fed newborn/infant is unknown. As a precautionary measure, breast-feeding is not recommended during the use of Lucentis.
Fertility
There are no data available on fertility.
4.7. Effects on ability to drive and use machines
The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8). Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
4.8. Undesirable effects
Summary of the safety profile
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 section 4.4).
The adverse reactions experienced following administration of Lucentis in clinical studies are summarised in the table below.
Tabulated list of adverse reactions#
The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations
Very common
Nasopharyngitis
Common
Urinary tract infection*
Blood and lymphatic system disorders
Common
Anaemia
Immune system disorders
Common
Hypersensitivity
Psychiatric disorders
Common
Anxiety
Nervous system disorders
Very common
Headache
Eye disorders
Very common
Vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus.
Common
Retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid oedema, eyelid pain, conjunctival hyperaemia.
Uncommon
Blindness, endophthalmitis, hypopyon, hyphaema, keratopathy, iris adhesion, corneal deposits, corneal oedema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation.
Respiratory, thoracic and mediastinal disorders
Common
Cough
Gastrointestinal disorders
Common
Nausea
Skin and subcutaneous tissue disorders
Common
Allergic reactions (rash, urticaria, pruritus, erythema)
Musculoskeletal and connective tissue disorders
Very common
Arthralgia
Investigations
Very common
Intraocular pressure increased
# Adverse reactions were defined as adverse events (in at least 0.5 percentage points of patients) which occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis 0.5 mg than in those receiving control treatment (sham or verteporfin PDT).
* observed only in DME population
Product-class-related adverse reactions
In the wet AMD phase III studies, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in ranibizumab-treated patients. However, there was no consistent pattern among the different haemorrhages. There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical studies in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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.
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