Ranibizumab intravitreal injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of ranibizumab.
These products have been produced by recombinant technology using E.coli.
Drugs List
Therapeutic Indications
Uses
Macular oedema following branch or central retinal vein occlusion
Retinopathy of prematurity with zone 1, zone 2 or AP-ROP disease
Treatment of neovascular age-related macular degeneration
Treatment of proliferative diabetic retinopathy
Treatment of visual impairment due to diabetic macular oedema
Visual impairment due to choroidal neovascularisation (CNV)
Dosage
Treatment should be administered by ophthalmologists experienced in intravitreal injections.
Adults
500micrograms (0.05ml) given as a single intravitreal injection. The interval between two doses injected into the same eye should be at least four weeks.
Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity (there is no change in visual acuity and no change in other signs and symptoms of the disease under continued treatment). In patients with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR) and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO), initially three or more consecutive monthly injections may be needed.
Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters. If visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, this medication should be discontinued.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques such as optical coherence tomography or fluorescein angiography.
If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. Extend the treatment interval by no more than two weeks at a time for wet AMD and by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there is insufficient data to conclude on the length of these intervals. If disease activity recurs, shorten the treatment interval accordingly.
Treatment of CNV visual impairment is determined for each patient based on disease activity. Some patients may need only one injection during the first 12 months, whereas others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year.
Ranibizumab and laser photocoagulation in DME and in macular oedema secondary to BRVO:
There is some experience of this medication administered concomitantly with laser photocoagulation. When given on the same day, administer ranibizumab at least 30 minutes after laser photocoagulation. The medication can be administered in patients who have received previous laser photocoagulation.
Children
Treatment of retinopathy of prematurity (ROP)
Preterm infants
0.2mg (0.02ml) given as an intravitreal injection initiated with a single injection per eye. This can be given bilaterally on the same day. If signs of disease activity, up to 3 injections per eye may be administered within six months of treatment initiation. The interval between two doses injected into the same eye should be at least four weeks.
Administration
For intravitreal use only.
In preterm infants, insert injection needle into the eye 1.0 to 2.0mm posterior to the limbus with the needle pointing towards the optic nerve.
Contraindications
Breastfeeding
Ocular infection
Periocular infection
Recent ocular surgery
Severe intra-ocular inflammation
Precautions and Warnings
Children under 18 years
Females of childbearing potential
Risk factors for retinal pigment epithelial tears
Cerebrovascular accident
History of transient ischaemic attack
Pregnancy
Suspend treatment if planned surgery within next 28 days
Advise patient blurred vision may affect ability to drive/operate machinery
Not all formulations are licensed for all uses
Discard any unused portion
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Monitor during the week following injection for signs of infection
Monitor intra-ocular pressure post injection and manage appropriately
Monitor visual acuity during and after treatment
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any unexpected changes in eye symptoms immediately
Discontinue if rhegmatogenous retinal detachment or stage 3/4 macular holes
Suspend if best-corrected visual activity declines by 30 letters or more
Suspend treatment if central foveal haemorrhage
Suspend treatment if foveal haemorrhage >50% of the total lesion area
Suspend treatment if intraocular pressure of >29 mmHg
Suspend treatment if retinal break or tear develops
Female: Contraception required during and for 3 months after treatment
There is a potential for immunogenicity with ranibizumab. As there is a potential for an increased systemic exposure in patients 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.
Ranibizumab should not be administered concurrently with other anti-VEGF (vascular endothelial growth factor) medicinal products (systemic or ocular).
Pregnancy and Lactation
Pregnancy
Use ranibizumab with caution during pregnancy.
The manufacturer recommends ranibizumab is not used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Studies in cynomolgus monkeys have not indicated direct or indirect harmful effects regarding pregnancy or embryonal/foetal development. After ocular use, systemic exposure to ranibizumab is low but due to its mechanism of action, it is regarded as potentially teratogenic and embryotoxic and foetotoxic.
Lactation
Ranibizumab is contraindicated during breastfeeding.
The manufacturer advises that ranibizumab is not recommended when breastfeeding. The presence of ranibizumab in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abnormal sensation in eye
Allergic conjunctivitis
Anaemia
Anterior chamber inflammation
Anxiety
Arterial thrombosis
Arthralgia
Atrial fibrillation
Blepharitis
Blindness
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Conjunctivitis
Corneal abrasion
Corneal deposits
Corneal oedema
Corneal striae
Cough
Dry eyes
Endophthalmitis
Erythema
Eye pruritus
Eyelid oedema
Eyelid pain
Eyelid reaction
Floaters
Haemorrhage
Haemorrhage (injection site)
Headache
Hypersensitivity reactions
Hyphaema
Hypopyon
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iris adhesion
Iritis
Irritation (injection site)
Keratopathy
Local pain (injection site)
Nasopharyngitis
Nausea
Ocular discharge
Ocular discomfort
Ocular haemorrhage
Ocular hyperaemia
Ocular inflammation
Ocular irritation
Ocular pain
Photophobia
Photopsia
Posterior capsule opacification
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Retinal degeneration
Retinal detachment
Retinal disturbances
Retinal haemorrhage
Retinal pigment epithelial tear
Retinal tear
Sensation of foreign body in eye
Subcapsular cataract
Traumatic cataract
Urinary tract infections
Urticaria
Uveitis
Visual disturbances
Vitreous detachment
Vitreous disorder
Vitreous haemorrhage
Vitritis
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2019
Reference Sources
Summary of Product Characteristics: Lucentis 10mg/ml solution for injection. Novartis Pharmaceuticals UK Ltd. Revised October 2019.
Summary of Product Characteristics: Lucentis 10mg/ml solution for injection in pre-filled syringe. Novartis Pharmaceuticals UK Ltd. Revised October 2018.
Summary of Product Characteristics: Ongavia 10mg/ml solution for injection. Teva UK Ltd. Revised May 2022.
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