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Vabysmo is a brand name for Faricimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vabysmo is indicated for the treatment of adult patients with: • neovascular (wet) age-related macular degeneration (nAMD), • visual impairment due to diabetic macular oedema (DME), • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO). 3
Verbatim from this product's EMA label. Tap a section to expand.
This medicinal product must be administered by a qualified physician experienced in intravitreal injections. 05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 16 and/or 20 weeks after treatment initiation so that treatment can be individualised.
In patients without disease activity, administration of faricimab every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. 1). 4).
Monitoring between the dosing visits should be scheduled based on the patient's status and at the physician's discretion, but there is no requirement for monthly monitoring between injections. 05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed.
Thereafter, treatment is individualised using a treat -and-extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended in increments of up to 4 weeks. 1). Treatment intervals shorter than 4 weeks and longer than 4 months between injections have not been studied.
Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion but there is no requirement for monthly monitoring between injections. Duration of treatment This medicinal product is intended for long-term treatment.
If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, treatment should be discontinued. Delayed or missed dose If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician’s discretion.
2). 4). 2). 2). Paediatric population There is no relevant use of this medicinal product in the paediatric population for the indications of nAMD, DME, and RVO. Method of administration For intravitreal use only. Each pre-filled syringe or vial should only be used for the treatment of a single eye.
Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the pre-filled syringe or vial should not be used. The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, a sterile drape and a sterile eyelid speculum (or equivalent).
Summary of the safety profile The most frequently reported adverse reactions were cataract (10%), conjunctival haemorrhage (7%), vitreous detachment (4%), IOP increased (4%), vitreous floaters (4%), eye pain (3%), and retinal pigment epithelial tear (nAMD only) (3%).
4). Tabulated list of adverse reactions The adverse reactions reported in clinical studies or during post-marketing surveillance are listed according to the MedDRA system organ class and ranked by 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) or not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Frequencies of adverse reactions MedDRA System organ class Frequency category Eye disorders Cataract Common Conjunctival haemorrhage Common Vitreous detachment Common Increased intraocular pressure Common Vitreous floaters Common Retinal pigment epithelial tear (nAMD only) Common Eye pain Common Corneal abrasion Uncommon Eye irritation Uncommon Increased lacrimation Uncommon Blurred vision Uncommon Eye pruritus Uncommon Ocular discomfort Uncommon Ocular hyperaemia Uncommon Iritis Uncommon Reduced visual acuity Uncommon Uveitis Uncommon Endophthalmitis Uncommon Sensation of foreign body Uncommon Vitreous haemorrhage Uncommon Vitritis Uncommon Iridocyclitis Uncommon Conjunctival hyperaemia Uncommon Procedural pain Uncommon Retinal tear Uncommon Rhegmatogenous retinal detachment Uncommon Transiently reduced visual acuity Rare Traumatic cataract Rare Retinal vasculitis* Not known Retinal occlusive vasculitis* Not known 9 Terms marked with asterisk (*) are adverse reactions which have been identified based on post- marketing spontaneous reports.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. 8). Proper aseptic injection techniques must always be used when administering Vabysmo.
Patients should be instructed to report any symptoms, such as pain, loss of vision, photophobia, blurred vision, floaters, or redness, suggestive of endophthalmitis or any of the above- mentioned adverse reactions without delay, to permit prompt and appropriate management.
Patients with increased frequency of injections may be at increased risk of procedural complications. 8). Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the IOP is ≥ 30 mmHg). In all cases, both the IOP and perfusion of the optic nerve head must be monitored and managed appropriately.
Systemic effects Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors and there is a theoretical risk that these may be related to VEGF inhibition.
A low incidence rate of arterial thromboembolic events was observed in the faricimab clinical trials in patients with nAMD, DME, and RVO. This is similar to that reported in the other clinical trials with anti-VEGF inhibitors in patients.
There are limited data on the safety of faricimab treatment in DME patients with high blood pressure (≥ 140/90 mmHg) and vascular disease, and in nAMD and RVO patients ≥ 85 years of age. 8). 8). Bilateral treatment The safety and efficacy of faricimab administered in both eyes concurrently have not been studied.
Bilateral treatment could cause bilateral ocular adverse reactions and/or potentially lead to an increase in systemic exposure, which could increase the risk of systemic adverse reactions. Until data for bilateral use become available, this is a theoretical risk for faricimab.
1. Active or suspected ocular or periocular infections. Active intraocular inflammation.
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8). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface should be administered prior to the injection. Pre-filled syringe The pre-filled syringe contains an excess of volume.
The excess volume must be expelled before injecting the recommended dose. Injecting the entire volume of the pre-filled syringe could result in overdose. 6). 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 slowly; a different scleral site should be used for subsequent injections. 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 slowly; a different scleral site should be used for subsequent injections.
Post-injection monitoring After injection, any unused medicinal product or waste material should be disposed of in accordance with local requirements. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available. g. vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay.
6. 5
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. 4). Retinal vasculitis and retinal occlusive vasculitis have also been reported in patients treated with IVT therapies.
Product-class-related adverse reactions There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. 4). Across indications, no notable difference between the groups treated with faricimab and the comparator were observed.
4). 4% of patients with nAMD, DME, and RVO randomised to faricimab, respectively. The clinical significance of anti- faricimab antibodies on safety is unclear at this time. 8%; RVO). 3%; RVO). Anti-faricimab antibodies were not associated with an impact on clinical efficacy or systemic pharmacokinetics.
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.
6 Concomitant use of other anti-VEGF There are no data available on the concomitant use of faricimab with anti-VEGF medicinal products in the same eye. Faricimab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
Use of other injection needles with the pre-filled syringe Only use the pre-filled syringe with the co-packaged injection filter needle. There are no clinical data available on the use of other injection needles with the pre-filled syringe.
Withholding treatment Treatment should be withheld in patients with: • Rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break; treatment should not be resumed until an adequate repair has been performed. • Treatment related decrease in Best Corrected Visual Acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; treatment should not be resumed earlier than the next scheduled treatment.
• An intraocular pressure of ≥ 30 mmHg. • 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; treatment should not be resumed earlier than the next scheduled treatment.
Retinal pigment epithelial tear Retinal pigment epithelial (RPE) tear is a complication of pigment epithelial detachment (PED) in patients with nAMD. Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for nAMD, include a large and/or high pigment epithelial detachment.
When initiating faricimab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears. RPE tears are common in nAMD patients with PED, treated with intravitreal anti-VEGF agents including faricimab.
5%). The majority of events occurred during the loading phase, and were mild to moderate, without impact on vision. Populations with limited data There is only limited experience in the treatment of nAMD and RVO patients ≥ 85 years, and DME patients with type I diabetes, patients with HbA1c over 10%, patients with high-risk proliferative diabetic retinopathy (DR), high blood pressure (≥ 140/90 mmHg) and vascular disease, sustained dosing intervals shorter than every 8 weeks (Q8W), or nAMD, DME, and RVO patients with active systemic infections.
There is limited safety information on sustained dosing intervals of 8 weeks or less and these may be associated with a higher risk of ocular and systemic adverse reactions, including serious adverse reactions. There is also no experience of treatment with faricimab in diabetic or RVO patients with uncontrolled hypertension and patients with RVO who have failed previous therapy.
This lack of information should be considered by the physician when treating such patients. 7 Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. Polysorbate content This medicinal product […]