Byooviz · 4.5 Interaction with other medicinal products and other forms of interaction · 2

HOS-099803 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile 6 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. Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4). 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. Infections and infestations Very common Nasopharyngitis Common Urinary tract infection* Blood and lymphatic system disorders Common Anaemia Immune system disorders Common Hypersensitivity Psychiatric disorders Common Anxiety Nervous system disorders Very common Headache Eye disorders Very common Vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus. Common Retinal degeneration, retinal disorder, retinal detachment,

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HOS-099809 · has-adverse-reaction-information · PDF-Seite 29

29 Summary of the safety profile 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. Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4). 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. Infections and infestations Very common Nasopharyngitis Common Urinary tract infection* Blood and lymphatic system disorders Common Anaemia Immune system disorders Common Hypersensitivity Psychiatric disorders Common Anxiety Nervous system disorders Very common Headache Eye disorders Very common Vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus. Common Retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigm

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HOS-099805 · has-contraindication-information · PDF-Seite 27

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

HOS-099799 · has-contraindication-information · PDF-Seite 4

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

HOS-099804 · has-indication-information · PDF-Seite 25

Byooviz 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 retinal vein occlusion (branch RVO or central RVO)  The treatment of visual impairment due to choroidal neovascularisation (CNV)

HOS-099798 · has-indication-information · PDF-Seite 2

Byooviz 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 retinal vein occlusion (branch RVO or central RVO)  The treatment of visual impairment due to choroidal neovascularisation (CNV)

HOS-099807 · has-interaction-information · PDF-Seite 29

No formal interaction studies have been performed. For the adjunctive use of verteporfin photodynamic therapy (PDT) and ranibizumab in wet AMD and PM, see section 5.1. For the adjunctive use of laser photocoagulation and ranibizumab in DME and BRVO, see sections 4.2 and 5.1. In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with ranibizumab was not affected by concomitant treatment with thiazolidinediones.

HOS-099801 · has-interaction-information · PDF-Seite 6

No formal interaction studies have been performed. For the adjunctive use of verteporfin photodynamic therapy (PDT) and ranibizumab in wet AMD and PM, see section 5.1. For the adjunctive use of laser photocoagulation and ranibizumab in DME and BRVO, see sections 4.2 and 5.1. In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with ranibizumab was not affected by concomitant treatment with thiazolidinediones.

HOS-099808 · has-pregnancy-information · PDF-Seite 29

Women of childbearing potential/contraception in females Women of childbearing potential should use effective contraception during treatment. Pregnancy For ranibizumab no clinical data on exposed pregnancies are available. Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development (see section 5.3). The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic. Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus. For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child. Breast-feeding Based on very limited data, ranibizumab may be excreted in human milk at low levels. The effect of ranibizumab on a breast-fed newborn/infant is unknown. As a precautionary measure, breast-feeding is not recommended during the use of ranibizumab. Fertility There are no data available on fertility.

HOS-099802 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential/contraception in females Women of childbearing potential should use effective contraception during treatment. Pregnancy For ranibizumab no clinical data on exposed pregnancies are available. Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development (see section 5.3). The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic. Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus. For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child. Breast-feeding Based on very limited data, ranibizumab may be excreted in human milk at low levels. The effect of ranibizumab on a breast-fed newborn/infant is unknown. As a precautionary measure, breast-feeding is not recommended during the use of ranibizumab. Fertility There are no data available on fertility.

HOS-099806 · has-warning-information · PDF-Seite 27

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 Intravitreous injections, including those with ranibizumab, 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 ranibizumab. 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 Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of ranibizumab. Sustained IOP increases have also been identified (see section 4.8). Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately. Patients should be informed of the symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8). 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. Immunogenicity 27 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) Ranibizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular). Withholding ranibizumab The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: 

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HOS-099800 · has-warning-information · PDF-Seite 4

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 Intravitreous injections, including those with ranibizumab, 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 ranibizumab. 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. Sustained IOP increases have also been identified (see section 4.8). Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately. Patients should be informed of the symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8). 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. 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 4 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) Ranibizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular). Withholding ranibizumab in adults The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment

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