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Ranibizumab - Lucentis

SPEP 580 Rotation Presentaiton
by

Andrea Tang

on 4 February 2013

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Transcript of Ranibizumab - Lucentis

Take Home Points Ranibizumab is a VEGF inhibitor and decreases neovascularization and vision loss
Intravitreal injection
Batched to obtain 3 treatments per 0.3 mL vial of 10 mg/mL solution
Adverse effects: mainly ocular, thromboembolic events
Coverage only available for AMD and must meet other EDS criteria (prescriber agreement)
Billed on a microgram basis
Coverage for macular edema due to diabetes or retinal vein occlusion currently under review Indications Ranibizumab - Lucentis Ranibizumab is indicated by Health Canada for the treatment of three conditions:
neovascular (wet) age-related macular degeneration (AMD)
visual impairment due to diabetic macular edema
visual impairment due to macular edema secondary to retinal vein occlusion
The Drug Plan only provides coverage for AMD Age-related Macular Degeneration (AMD) Ranibizumab Class: ear, eye, nose, throat drug, miscellaneous
Recombinant humanized immunoglobulin G1 kappa monoclonal fragment
MOA: vascular endothelial growth factor inhibitor (VEGF inhibitor)
Dosage Forms
In Canada, available as 10 mg/mL (0.3 mL) intravitreal solution
Batching done in health regions with eye care centres/ophthalmologists
No generic product is available Adverse Effects > 10%
CV: arterial thromboembolic events
Ocular: conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, blurred vision/visual disturbance, intraocular inflammation, foreign body sensation

1-10%
CV: stroke
Ocular: retinal degeneration, injection site hemorrhage
Miscellaneous: ranibizumab antibodies, influenza

Patient Education Administration Intravitreal injection only, 0.5 mg (0.05 mL) once every month
For AMD: frequency of injections may be reduced after the first 4 injections to once every 3 months if monthly injections aren't feasible (PIER)
Patient should have adequate anesthesia and a broad spectrum topical antibiotic (e.g., Viagmox) before the procedure Also called age-related maculopathy or macular syndrome

Adults >50 years old are mostly affected

An aging retina is characterized by:
Drusen
Geographic atrophy of retinal pigment epithelium
Neovascularization

This can lead to visual impairment AMD - Classification AREDS Classification:
Early- any combination of multiple small drusen, few medium-sized drusen, pigmentary abnormalities
Intermediate- characterized by 1 or more of: at least 1 large drusen, medium-sized drusen, or geographic atrophy that does not extend to center of fovea
Advanced/Late- choroidal neovascularization and any of its potential sequelae (e.g., lipid deposition, hemorrhage)
Wet vs. dry AMD AMD - Risk Factors The cause of AMD is generally unknown, but it is likely that it involves:
Oxidative effects
Genetics/family history
Age
Cigarette Smoking
Race
Hypertension DPEBB/EDS/CADTH CDEC recommends that ranibizumab be listed for all three of the Health Canada indications

BUT the Drug Plan only provides EDS coverage for ranibizumab when used for wet AMD and the circumstances as outlined in Appendix A

Prescriber agreement that states the patient meets EDS criteria and is eligible for treatment
The quantity billed for is in micrograms
Coverage for macular edema due to retinal vein occlusion and diabetic macular edema is currently under review Comparator Drugs/Treatments For subfoveal neovascularization:
Bevacizumab (Avastin)*
Pegaptanib (Macugen)- but ANCHOR study deemed Lucentis was superior
Photodynamic Therapy w/verteporfin (Visudyne)
Afibercept (new drug approved by FDA in 2011)
Thermal laser photocoagulation surgery Thank you!
Full transcript