Vabysmo · 4.8 Undesirable effects · 1

HOS-099895 · has-adverse-reaction-information · PDF-Seite 8

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%). The most serious adverse reactions were uveitis (0.5%), endophthalmitis (0.4%), vitritis (0.4%), retinal tear (0.2%), rhegmatogenous retinal detachment (0.1%), and traumatic cataract (< 0.1%) (see section 4.4). 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. 8 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099891 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or suspected ocular or periocular infections. Active intraocular inflammation.

HOS-099890 · has-indication-information · PDF-Seite 2

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).

HOS-099893 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. Based on the biotransformation and elimination of faricimab (see section 5.2), no interactions are expected. However, faricimab should not be administered concurrently with other systemic or ocular anti-VEGF medicinal products (see section 4.4).

HOS-099894 · has-pregnancy-information · PDF-Seite 7

Women of childbearing potential Women of childbearing potential should use effective contraception during treatment and for at least 3 months following the last intravitreal injection of faricimab. Pregnancy There are no or limited amount of data from the use of faricimab in pregnant women. The systemic exposure to faricimab is low after ocular administration, but due to its mechanism of action (i.e. VEGF inhibition), faricimab must be regarded as potentially teratogenic and embryo-/foetotoxic (see section 5.3). Faricimab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. 7 Breast-feeding It is unknown whether faricimab is excreted in human milk. A risk to the breast-fed newborn/infant cannot be excluded. Vabysmo should not be used during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from faricimab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No effects on reproductive organs or fertility were observed in a 6-month cynomolgus monkey study with faricimab (see section 5.3).

HOS-099892 · has-warning-information · PDF-Seite 5

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. Intravitreal injection-related reactions Intravitreal injections, including those with faricimab, 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 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. Intraocular pressure increases Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with faricimab (see section 4.8). 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. 5 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 therapies 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. Immunogenicity As this is a therapeutic protein, there is a potential for immunogenicity with faricimab (see section 4.8). 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 against far

Auszug; vollständigen Abschnitt im Original lesen.