Lanadelumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Kallikrein |
| Clinical data | |
| Trade names | Takhzyro |
| Other names | lanadelumab-flyo |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6468H10016N1728O2012S47 |
| Molar mass | 145684.18 g·mol−1 |
Lanadelumab, sold under the brand name Takhzyro, is a human monoclonal antibody (class IgG1 kappa)[7] that targets plasma kallikrein (pKal)[8] in order to promote prevention of angioedema in people with hereditary angioedema.[9][10] Lanadelumab, was approved in the United States as the first monoclonal antibody indicated for prophylactic treatment to prevent hereditary angioedema attacks.[5][11] Lanadelumab is the first treatment for hereditary angioedema prevention made by using cells within a lab, not human plasma.[12]
Common side effects include pain associated with injection site reactions, injection site bruising, upper respiratory infection, headache, rash, myalgia, dizziness, and diarrhea.[12]
The US Food and Drug Administration approved the use of lanadelumab in August 2018, for people that are 12 years and older and have either type I or type II hereditary angioedema.[13][11][14]
- ^ "Lanadelumab (Takhzyro) Use During Pregnancy". Drugs.com. 19 September 2018. Archived from the original on 20 October 2020. Retrieved 4 September 2020.
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/takhzyro-takeda-pharmaceuticals-australia-pty-ltd
- ^ "Takhzyro Product information". Health Canada. 25 April 2012. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
- ^ "Takhzyro 300 mg solution for injection in pre-filled syringe - Patient Information Leaflet (PIL)". (emc). 1 July 2022. Archived from the original on 19 April 2021. Retrieved 1 July 2022.
- ^ a b "Takhzyro- lanadelumab-flyo solution Takhzyro- lanadelumab-flyo injection, solution". DailyMed. 17 February 2022. Archived from the original on 20 January 2022. Retrieved 30 May 2022.
- ^ "Takhzyro EPAR". European Medicines Agency. 17 October 2018. Archived from the original on 19 October 2021. Retrieved 30 May 2022.
- ^ Kenniston JA, Faucette RR, Martik D, Comeau SR, Lindberg AP, Kopacz KJ, et al. (August 2014). "Inhibition of plasma kallikrein by a highly specific active site blocking antibody". The Journal of Biological Chemistry. 289 (34): 23596–23608. doi:10.1074/jbc.M114.569061. PMC 4156074. PMID 24970892.
{{cite journal}}: CS1 maint: overridden setting (link) - ^ Banerji A, Busse P, Shennak M, Lumry W, Davis-Lorton M, Wedner HJ, et al. (February 2017). "Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis" (PDF). The New England Journal of Medicine. 376 (8): 717–728. doi:10.1056/NEJMoa1605767. hdl:2434/550555. PMID 28225674. S2CID 54486011. Archived (PDF) from the original on 31 October 2021. Retrieved 2 September 2019.
{{cite journal}}: CS1 maint: overridden setting (link) - ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Lanadelumab Archived 2 April 2016 at the Wayback Machine, American Medical Association.
- ^ World Health Organization (2015). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 114" (PDF). WHO Drug Information. 29 (4). Archived (PDF) from the original on 7 August 2020. Retrieved 5 October 2020.
- ^ a b "FDA approves new treatment for rare hereditary disease". U.S. Food and Drug Administration. 30 September 2021. Archived from the original on 19 January 2021. Retrieved 15 March 2021. This article incorporates text from this source, which is in the public domain.
- ^ a b "www.takhzyro.com". Archived from the original on 3 August 2021. Retrieved 1 July 2022.
- ^ "FDA approves new treatment for rare hereditary disease". U.S. Food and Drug Administration (Press release). 30 September 2021. Archived from the original on 7 February 2023. Retrieved 10 February 2023. This article incorporates text from this source, which is in the public domain.
- ^ "Drug Trials Snapshots: Takhzyro". U.S. Food and Drug Administration (FDA). 9 February 2019. Archived from the original on 30 September 2022. Retrieved 10 February 2023.