7 November 2012

Bevacizumab SPC updated – Why?

This post is not specifically about the stability of BmAb eye syringes.

However, given the attempts by Novartis to stop the use of BmAb as an unlicensed alternative to their Ranibizumab (Lucentis), we thought it interesting at least that Roche have added some warnings to their Bevacizumab SPC in relation to its unlicensed intravitreal use.

We compared the added sections of the BmAb SPC to the Lucentis SPC. Every single new warning that appears in the BmAb SPC also appears in the Lucentis SPC along with many others. We are sure many of you have already done this and come to your conclusions about its relevance.

We have highlighted the similarities below;

Red = Special warnings and precautions
Amber = Adverse reactions
Blue = Product class related adverse reaction

The text below is the new section of the Bevacizumab SPC.

Intravitreal use

Avastin is not formulated for intravitreal use.

Eye disorders

Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients. These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage. Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.

Systemic effects following intravitreal use

A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy. Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors, and there is a theoretical risk that these may relate to VEGF inhibition.

Weblink to Lucentis (Ranibizumab) SPC – click here
Weblink to Avastin (Bevacizumab) SPC – click here

 

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