Prescribing information

 

   

Information about recommended dosing and administration of LUCENTIS.

The recommended dose of LUCENTIS in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml. The interval between 2 doses injected into the same eye should be at least 4 weeks.1

Treatment is initiated with 1 injection per month until maximum VA is achieved and/or there are no signs of disease activity. In patients with wet AMD, DMO, PDR and RVO, initially, 3 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.1

LUCENTIS is available in a pre-filled syringe, saving time (vs vial)2,3

 

 Image of the LUCENTIS pre-filled syringe

Data from a cross-sectional, 2-centre, time-and-motion study to assess and quantify the potential time saved when preparing a LUCENTIS pre-filled syringe vs vial injections in a real-life clinical setting. The data for preparation time of 24 pre-filled syringes and 24 vial injections were collected at 2 hospitals in the UK over 4 half-day sessions. Within each hospital, both pre-filled syringe and vial injections were prepared by the same team of healthcare professionals and data collection was performed by the same independent healthcare professional observer. The primary endpoint was the total time taken to prepare a LUCENTIS intravitreal injection using the pre-filled syringe and the vial. This was defined as the sum of the individual steps involved. Secondary endpoints were: mean total preparation time using PFS and vial; the difference in sample preparation means across the 2 hospitals; and answers to survey questionnaires on convenience benefit of injection preparation procedures.

LUCENTIS Treat & Extend* is a personalised treatment regimen1,2

Wet AMD1

Diagram showing the LUCENTIS T&E regimen in wet AMD

DMO1

Diagram showing the LUCENTIS T&E regimen in DMO

*Once maximum VA is achieved and/or there are no signs of disease activity.1

PDR and RVO1

For the treatment of PDR and RVO, treatment intervals may also be gradually extended; however, there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.

CNV1

The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; 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. 

The recommended dose of LUCENTIS in preterm infants is 0.2 mg given as an intravitreal injection. This corresponds to an injection volume of 0.02 ml.1

Treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In total, up to 3 injections per eye may be administered within 6 months of treatment initiation if there are signs of disease activity.The interval between 2 doses injected into the same eye should be at least 4 weeks.1

*Once maximum VA is achieved and/or there are no signs of disease activity.1

Stability/stable: no change in VA and/or signs and symptoms of the disease under continued treatment.1

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.

 

AMD, age-related macular degeneration; DMO, diabetic macular oedema; PDR, proliferative diabetic retinopathy; ROP, retinopathy of prematurity; RVO, retinal vein occlusion; VA, visual acuity.

References

  1. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
  2. LUCENTIS® (ranibizumab) in Pre-filled Syringe Summary of Product Characteristics, October 2019.
  3. Ayan F et al. Poster presented at 17th ESASO Retina Academy, 29 June–1 July 2017, Berlin, Germany.
LUC20-C030i 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]