Ranibizumab

(BAN, USAN, rINN)
Synonyms: Ranibizumabum; rhuFab V2. Immunoglobulin G1, anti-(human vascular endothelial growth factor) Fab fragment (human-mouse monoclonal rhuFAB V2 monoclonal rhuFAB V2
Cyrillic synonym: Ранибицумаб.

💊 Chemical information

CAS — 347396-82-1.
ATC — S01LA04.
ATC Vet — QS01LA04.

💊 Adverse Effects and Precautions

Intra-ocular inflammation and raised intra-ocular pressure may occur with ranibizumab. Adverse effects relating to the injection procedure include endophthalmitis, rhegmatogenous retinal detachment, retinal tear, and iatrogenic traumatic cataract. Patients should be monitored for signs of infections for a week after the procedure. Common but less serious ocular adverse effects include red eye, eye pain, vitreous floaters, eye irritation, increased lachrymation, and the sensation of a foreign body in the eye. Non-ocular adverse effects that have been reported include headache, nausea, arthralgia, back pain, bronchitis, anaemia, and hypertension. Arterial thromboembolic events are a theoretical possibility with vascular endothelial growth factor inhibitors. Ranibizumab is contra-indicated in patients with active or suspected ocular or periocular infections, or active severe intra-ocular inflammation.

Stroke.

The manufacturers of ranibizumab have reported that interim analysis of results from an ongoing study have revealed a higher incidence of stroke in a group of patients given doses of 500 micrograms compared with a group receiving 300 micrograms. Patients with a history of stroke appeared to be at greater risk.

💊 Uses and Administration

Ranibizumab is a recombinant humanised monoclonal antibody used in the treatment of neovascular (wet) age-related macular degeneration. It is given by intravitreal injection into the affected eye in doses of 500 micrograms once a month initially for 3 to 4 months. In the UK, after the first 3 months, maintenance treatment is based on regular assessment of visual acuity, with ranibizumab being given if the patient had a loss of greater than 5 letters in visual acuity; the interval between consecutive doses should be at least one month. In the USA, if monthly administration is not feasible after the first four injections, treatment may be given once every 3 months, although this is not as effective as monthly doses.

Age-related macular degeneration.

Ranibizumab is a recombinant humanised monoclonal antibody fragment related to bevacizumab used in the treatment of (wet) age-related macular degeneration (AMD). It binds to and inhibits vascular endothelial growth factor A (VEGF-A), which is a stimulant of angiogenesis thought to play a role in the neovascularisation and retinal changes associated with AMD. Ranibizumab inhibits all active forms of VEGF-A.1 Positive outcomes have been reported from two international multicentre randomised controlled phase III studies.2,3 Vision loss was prevented and mean visual acuity improved in patients given either monthly injections of 300 micrograms or 500 micrograms for 2 years compared with patients receiving sham injections.2 Ranibizumab given in the same doses was also shown to be superior to photodynamic therapy with verteporfin at 1 year in the second study.3 A review4 of interim results of other ongoing phase III studies of ranibizumab for AMD suggests that reducing the dosing interval to once every 3 months is less satisfactory than monthly injections, although tailoring the treatment to morphological parameters was as effective at 1 year as giving a fixed dosage regimen. However, ranibizumab in combination with photodynamic therapy does not necessarily result in better visual acuity outcomes and may even be worse than ranibizumab alone. A systematic review5 of 5 randomised controlled studies found that ranibizumab was effective in reducing the risk of loss of visual acuity, and also improved visual acuity in a significant proportion of eyes.
1. Blick SKA, et al. Ranibizumab. Drugs 2007; 67: 1199–1206
2. Rosenfeld PJ, et al. for the MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006; 355: 1419–31
3. Brown DM, et al. for the ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006; 355: 1432–44
4. Rosenfeld PJ, et al. Ranibizumab: phase III clinical trial results. Ophthalmol Clin North Am 2006; 19: 361–72
5. Vedula SS, Krzystolik MG. Antiangiogenic therapy with antivascular endothelial growth factor modalities for neovascular age-related macular degeneration. Available in The Cochrane Database of Systematic Reviews; Issu
2. Chichester: John Wiley; 2008 (accessed 06/06/08).

💊 Preparations

Proprietary Preparations

Austral.: Lucentis; Cz.: Lucentis; Fr.: Lucentis; Gr.: Lucentis; Indon.: Lucentis; Malaysia: Lucentis; Port.: Lucentis; UK: Lucentis; USA: Lucentis.
Published May 08, 2019.