 | |
| Clinical data | |
|---|---|
| Trade names | Tegsedi |
| Other names | GSK-2998728, ISIS-420915 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Antisense oligonucleotides |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C230H318N69O121P19S19 |
| Molar mass | 7183.08 g·mol−1 |
| 3D model (JSmol) | |
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| |
Inotersen, sold under the brand name Tegsedi, is a 2'-O-(2-methoxyethyl) (2'-MOE) antisense oligonucleotide medication used for the treatment of nerve damage in adults with hereditary transthyretin-mediated amyloidosis.[6][7] The sequence is TCTTG GTTACATGAA ATCCC, where C is methylated C, and the first and third section (bases 1-5 and 16–20, separated from the middle section by spaces) are MOE-modified.[8]
The most common side effects are injection site reactions (redness, swelling, bleeding, pain, rash, and itching at the injection site), nausea, headache, tiredness, low platelet counts, and fever.[6]
Inotersen can cause serious side effects, including low platelet counts and kidney inflammation.[6] Because of these serious side effects, Inotersen is available in the United States only through a restricted program called the Tegsedi Risk Evaluation and Mitigation (REMS) Program.[6]
The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Tegsedi inotersen injection" (PDF). Product Monograph Including Patient Medication Information. Akcea Therapeutics, Inc. Archived (PDF) from the original on 1 June 2022. Retrieved 1 June 2022 – via The Drug and Health Product Register, Government of Canada.
- ^ "Tegsedi 284 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 15 October 2019. Archived from the original on 7 October 2020. Retrieved 3 October 2020.
- ^ "Tegsedi- inotersen injection, solution". DailyMed. 2 September 2020. Archived from the original on 7 October 2020. Retrieved 3 October 2020.
- ^ Cite error: The named reference
Tegsedi EPARwas invoked but never defined (see the help page). - ^ a b c d "Drug Trial Snapshot: Tegsedi". U.S. Food and Drug Administration (FDA). 23 July 2019. Archived from the original on 19 December 2019. Retrieved 18 December 2019.
This article incorporates text from this source, which is in the public domain.
- ^ Benson MD, Dasgupta NR, Monia BP (February 2019). "Inotersen (transthyretin-specific antisense oligonucleotide) for treatment of transthyretin amyloidosis". Neurodegenerative Disease Management. 9 (1): 25–30. doi:10.2217/nmt-2018-0037. PMID 30561247. S2CID 56178847.
- ^ Yu RZ, Collins JW, Hall S, Ackermann EJ, Geary RS, Monia BP, et al. (June 2020). "Population Pharmacokinetic-Pharmacodynamic Modeling of Inotersen, an Antisense Oligonucleotide for Treatment of Patients with Hereditary Transthyretin Amyloidosis". Nucleic Acid Therapeutics. 30 (3): 153–163. doi:10.1089/nat.2019.0822. PMC 7249474. PMID 32286934.
{{cite journal}}: CS1 maint: overridden setting (link) - ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original on 17 September 2020. Retrieved 16 September 2020.
