Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
Saphnelo 300 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to slightly yellow, pH 5.9 solution. |
Each mL of concentrate for solution for infusion contains 150 mg of anifrolumab.
One vial of 2.0 mL of concentrate contains 300 mg of anifrolumab (150 mg/mL).
Anifrolumab is a human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Anifrolumab |
Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biologic activity of type I IFNs. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T-cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in SLE. |
| List of Excipients |
|---|
|
Histidine |
2.0 mL of concentrate in a clear type I glass vial with an elastomeric stopper and a gray flip-off aluminium seal.
Pack size of 1 vial.
AstraZeneca AB, SE-151 85, Södertälje, Sweden
EU/1/21/1623/001
| Drug | Countries | |
|---|---|---|
| SAPHNELO | Austria, Australia, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
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