Prescribing information

 

   

Safety profile of LUCENTIS across its ophthalmic indications.

Ocular AEs reported following administration of LUCENTIS in clinical trials1*

Very common (≥1/10) 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, intraocular pressure increased  
Common (≥1/100 to <1/10) 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 (≥1/1,000 to <1/100) 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  

Non-ocular AEs reported following administration of LUCENTIS in clinical trials1*

Very common (≥1/10) Nasopharyngitis, headache, arthralgia
Common (≥1/100 to <1/10) Urinary tract infection, anaemia, hypersensitivity, anxiety, cough, nausea, allergic reactions (rash, urticaria, pruritus, erythema)

*Includes AEs (in at least 0.5% of patients) which occurred at a higher rate (at least 2%) in patients receiving treatment with LUCENTIS 0.5 mg than in those receiving control treatment (sham or verteporfin PDT).1

Observed only in DMO population.1

The safety of LUCENTIS in preterm infants was studied in a 24 week clinical trial (RAINBOW), which included 73 preterm infants with ROP treated with LUCENTIS 0.2 mg.1

  • Ocular AEs reported in ≥1 patient were retinal haemorrhage and conjunctival haemorrhage.
  • Non-ocular AEs reported in ≥1 patient were nasopharyngitis, anaemia, cough, urinary tract infection and allergic reactions.
  • AEs established for adult indications are considered applicable to preterm infants with ROP, though not all were observed in the RAINBOW trial.

Long-term safety in preterm infants with ROP treated with LUCENTIS has been studied for 2 years in the RAINBOW extension trial and showed no new safety signals (consistent with the established safety profile for LUCENTIS in adults).1

  • The safety profile in preterm infants has not been established beyond 2 years.

Indications1

LUCENTIS 0.5 mg 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 (DMO)
  • 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)

LUCENTIS 0.2 mg is indicated in preterm infants for:

  • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.

 

AE, adverse event; DMO, diabetic macular oedema; ROP, retinopathy of prematurity.

Reference

  1. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
LUC20-C030h September 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]