Vabysmo Special Precautions

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: Intravitreal injections, including those with Vabysmo have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment and retinal tear (see Adverse Reactions). 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 previously mentioned events without delay, to permit prompt and appropriate management.
Intraocular pressure increases: Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with Vabysmo (see Adverse Reactions). Sustained (present at 2 or more consecutive visits) IOP increases >21 mmHg have also been reported. 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.
Vabysmo has not been studied in patients with poorly controlled glaucoma. Special precaution is needed in patients with poorly controlled glaucoma.
Systemic effects: Arterial thromboembolic events (ATEs): Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors, including Vabysmo, and there is a theoretical risk that these may be related to VEGF inhibition.
There is limited data on the safety of Vabysmo in patients with history of stroke or transient ischemic attack or myocardial infarction.
Immunogenicity: As this is a therapeutic protein, there is a potential for immunogenicity with Vabysmo (see Adverse Reactions). Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which might be a clinical sign attributable to hypersensitivity (see Adverse Reactions).
Bilateral treatment: The safety and efficacy of Vabysmo administered in both eyes concurrently have not been studied.
Concomitant use of other anti-VEGF: There are no data available on the concomitant use of Vabysmo with anti-VEGF medicinal products or other therapies (e.g., photodynamic therapy) for the treatment of nAMD or DMO in the same eye. Vabysmo should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
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); 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: 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 Vabysmo therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Populations with limited data: In nAMD clinical trials, there is limited data on patients with a total lesion size >9 disc areas on fundus fluorescein angiography. There is only limited experience in the treatment of DMO patients with HbA1c over 10%, patients with high-risk proliferative diabetic retinopathy (DR), or nAMD and DMO patients with active systemic infections. There is also no experience of treatment with Vabysmo in diabetic patients with uncontrolled hypertension.
This lack of information should be considered by the physician when treating such patients.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free".
Effects on ability to drive and use machines: Vabysmo may have a minor influence on the ability to drive and use machines due to possible temporary visual disturbances following the intravitreal injection and the associated eye examination. Patients should not drive or use machines until visual function has recovered sufficiently.