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.

Storage at ambient temperature: not provided by manufacturer

Comments Do not freeze. Keep the vial in the outer carton in order to protect from light.

28 September 2020
London MI Service

New Medicines

Gazyvaro (EU), Gazyva (US) Proliferative lupus nephritis

Information

Gazyvaro (EU), Gazyva (US)
Licence extension / variation
Roche
Roche

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
Roche

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