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Ximluci is a brand name for Ranibizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ximluci 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…
Verbatim from this product's EMA label. Tap a section to expand.
Ximluci must be administered by a qualified ophthalmologist experienced in intravitreal injections. 5 mg given as a single intravitreal injection. 05 mL. The interval between two doses injected into the same eye should be at least four weeks.
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. 3 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, Ximluci should be discontinued. 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.
1). 1). When given on the same day, Ximluci should be administered at least 30 minutes after laser photocoagulation. Ximluci can be administered in patients who have received previous laser photocoagulation. Ximluci and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of ranibizumab and verteporfin.
Special populations Elderly No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME. 2). Hepatic impairment Ranibizumab has not been studied in patients with hepatic impairment.
Summary of the safety profile 7 The majority of adverse reactions reported following administration of ranibizumab are related to the intravitreal injection procedure. The most frequently reported ocular adverse reactions following injection of ranibizumab 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. 4). The adverse reactions experienced following administration of ranibizumab in clinical trials 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. 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 ranibizumab clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
8). Proper aseptic injection techniques must always be used when administering Ximluci. 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 In adults transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of ranibizumab. 8). Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
8). Bilateral treatment Limited data on bilateral use of ranibizumab (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment. 5 Immunogenicity There is a potential for immunogenicity with ranibizumab.
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) Ximluci should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular). Withholding Ximluci 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.
1. Patients with active or suspected ocular or periocular infections. Patients with active severe intraocular inflammation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, no special considerations are needed in this population. Paediatric population The safety and efficacy of Ximluci in children and adolescents below 18 years of age have not been established. 1 but no recommendation on a posology can be made.
Method of administration Single-use vial for intravitreal use only. 05 mL for adults), a portion of the volume contained in the vial must be discarded prior to administration. 4 Ximluci should be inspected visually for particulate matter and discolouration 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).
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. 0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
05 mL is then delivered; a different scleral site should be used for subsequent injections. 6.
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 national reporting system listed in Appendix V.
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 in adults 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. Ranibizumab 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 ranibizumab 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 ranibizumab in patients with RVO presenting irreversible ischaemic visual function loss. In patients with PM, there are limited data on the effect of ranibizumab 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 ranibizumab in PM subjects with extrafoveal lesions. Systemic effects following intravitreal use 6 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. 8).