Vabysmo Special Precautions

General: In order to improve traceability of biological medicinal products, the trade 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. 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.
Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with VABYSMO. 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 and/or vision must be monitored and managed appropriately.
Systemic effects: Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may be related to VEGF inhibition.
Immunogenicity: As with all therapeutic proteins, there is the potential for immune response to VABYSMO. Patients should be instructed to report 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.
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 in the same eye.
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: There is only limited experience in the treatment of DME patients with HbA1c over 10%, patients with high-risk proliferative diabetic retinopathy (DR), or nAMD and DME 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.
Drug Abuse and Dependence: There is no evidence that VABYSMO has the potential for drug abuse and dependence.
Renal Impairment: No dose adjustment is required in patients with renal impairment (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).
Hepatic Impairment: The safety and efficacy of VABYSMO in patients with hepatic impairment has not been studied (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).
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.
Use in Children: The safety and efficacy of VABYSMO in pediatric patients have not been established.
Use in the Elderly: In the four Phase III clinical studies, approximately 60% (1,149/1,929) of patients randomized to treatment with VABYSMO were ≥ 65 years of age. No significant differences in efficacy or safety of VABYSMO were seen with increasing age in these studies (see Special Dosage Instructions under Dosage & Administration and Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).