User:Noxoug1/natalizumab-sztn
| Clinical data | |
|---|---|
| Trade names | Tyruko |
| Other names | PB006 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a605006 |
| License data |
|
| Routes of administration | Intravenous infusion |
| ATC code |
|
| Legal status | |
| Legal status | |
natalizumab-sztn, sold under the brand name Tyruko, is a medication used to treat multiple sclerosis and Crohn's disease. [2] It is a an anti-α4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis. It is given by intravenous infusion every 28 days.[1]
natalizumab-sztn was approved for medical use in the United States in August 2023.[2]
Medical uses[edit]
natalizumab-sztn is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. [2]
Tyruko is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).[2]
The approval of Tyruko, a biosimilar to Tysabri (natalizumab), was based on evidence that showed there are no clinically meaningful differences between the two products in terms of safety, purity and potency.[2]
Adverse effects[edit]
The most common adverse reactions were headache and fatigue in both the multiple sclerosis and Crohn's disease studies. Other common adverse reactions in the MS population were arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash.[1]
Other common adverse reactions in the CD population were upper respiratory tract infections and nausea [2]
History[edit]
The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.[2][3]
References[edit]
- ^ a b c "View full prescribing information for Tyruko" (PDF). Food and Drug Administration. Retrieved 25 August 2023.
- ^ a b c d e f g h "FDA grants accelerated approval to natalizumab-sztn-bcmm for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 24 August 2023. Retrieved 24 August 2023.
This article incorporates text from this source, which is in the public domain.
- ^ "Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis". Novartis. Retrieved 25 August 2023.
This article incorporates public domain material from the United States Department of Health and Human Services
