dm+d
25502511000001105
Refrigerated Storage
Gazyvaro Roche Products Ltd
Roche Products Ltd
Gazyvaro
1000mg concentrate for solution for infusion
Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
28 September 2020
London MI Service
New Medicines
Gazyvaro (EU), Gazyva (US) Proliferative lupus nephritis
Information
Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Monoclonal antibody that attaches to CD20 on B cells
Lupus nephritis is a complication of systemic lupus erythematosus, an autoimmune disease. Up to 60 percent of those with SLE will develop lupus nephritis, and up to 25 percent develop end-stage renal disease [1]. Lupus affects about 1 in 1,000 people in the UK. It is about six times more common in women than in men and more common in those of Caribbean, Chinese or Asian descent [2].
Proliferative lupus nephritis
Intravenous infusion
Gazyvaro (EU), Gazyva (US) Membranous nephropathy
Information
Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype
In membranous nephropathy, widespread thickening of the glomerular basement membrane occurs. It is a relatively common cause of nephrotic syndrome in adults. It progresses to end-stage kidney disease in 30-50% of patients. The remainder with idiopathic membranous nephropathy has a complete or partial spontaneous remission of nephrotic syndrome with stable renal function [1]. It has an estimated incidence of 8-10 cases per 1 million [2].
Membranous nephropathy
Intravenous infusion
Gazyvaro (EU), Gazyva (US) Serologically active extra-renal systemic lupus erythematosus (SLE)
Information
Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Genentech
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
Recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype
Lupus affected nearly 1 in 1,000 of the population in 2012 in the UK. The age-standardised incidence in the UK is 8.3 per 100,000/year for females and 1.4 per 100,000/year for males in the UK [1].
Serologically active extra-renal systemic lupus erythematosus (SLE)
Intravenous infusion