Chemical formula: C₂₁₅₈H₃₂₈₂N₅₆₂O₆₈₁S₁₂
Ranibizumab interacts in the following cases:
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. 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.
Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD and potentially also other forms of CNV, include a large and/or high pigment epithelial retinal detachment. When initiating ranibizumab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
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. 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.
It is unknown whether ranibizumab is excreted in human milk. Breast-feeding is not recommended during the use of ranibizumab.
Women of childbearing potential should use effective contraception during treatment.
There are no data available on fertility.
The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines. Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
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.
The adverse reactions experienced following administration of ranibizumab in clinical trials are summarised in the list below.
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.
Very common: Nasopharyngitis
Common: Urinary tract infection*
Common: Anaemia
Common: Hypersensitivity
Common: Anxiety
Very common: Headache
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 pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid oedema, eyelid pain, conjunctival hyperaemia.
Uncommon: Blindness, endophthalmitis, hypopyon, hyphaema, keratopathy, iris adhesion, corneal deposits, corneal oedema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation.
Common: Cough
Common: Nausea
Common: Allergic reactions (rash, urticaria, pruritus, erythema)
Very common: Arthralgia
Very common: Intraocular pressure increased
# Adverse reactions were defined as adverse events (in at least 0.5 percentage points of patients) which occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with ranibizumab 0.5 mg than in those receiving control treatment (sham or verteporfin PDT).
* observed only in DME population
In the wet AMD phase III studies, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in ranibizumab-treated patients. However, there was no consistent pattern among the different haemorrhages. There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. A low incidence rate of arterial thromboembolic events was observed in the ranibizumab clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
The safety of ranibizumab 0.2 mg was studied in a 6-month clinical trial (RAINBOW), which included 73 preterm infants with ROP treated with ranibizumab 0.2 mg. Ocular adverse reactions reported in more than one patient treated with ranibizumab 0.2 mg were retinal haemorrhage and conjunctival haemorrhage. Non-ocular adverse reactions reported in more than one patient treated with ranibizumab 0.2 mg were nasopharyngitis, anaemia, cough, urinary tract infection and allergic reactions. Adverse reactions established for adult indications are considered applicable to preterm infants with ROP, though not all were observed in the RAINBOW trial. The long-term safety profile in preterm infants has not been established.
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