Inotersen
| Clinical data | |
|---|---|
| Trade names | Tegsedi |
| Other names | GSK-2998728, ISIS-420915 |
| AHFS/Drugs.com | Monograph |
| License data | |
Antisense oligonucleotides | |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
JSmol) | |
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Inotersen, sold under the brand name Tegsedi, is a 2'-O-(2-methoxyethyl) (2'-MOE)
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 U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]
History
Inotersen was approved for medical use in the European Union in July 2018.[5]
The U.S. Food and Drug Administration (FDA) approved inotersen in October 2018.[6] The application for inotersen was granted orphan drug designation.[10]
The FDA approved inotersen based on evidence from one clinical trial (Trial 1/NCT01737398) that included 172 patients with hereditary transthyretin-mediated amyloidosis.[6] The trial was conducted at 24 sites in Australia, Europe, South America, and the United States.[6]
The benefits and side effects of inotersen were evaluated in one clinical trial that enrolled patients with hereditary transthyretin-mediated amyloidosis.[6] Patients were randomly assigned to receive inotersen or placebo by subcutaneous injection given once a week for 65 weeks.[6] During the first week of treatment, patients received three doses of treatment, followed by once weekly subcutaneous injections for 64 weeks.[6] Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.[6]
References
- FDA. Retrieved 22 October 2023.
- ^ "PrTEGSEDITM inotersen injection" (PDF). Product Monograph Including Patient Medication Information. Akcea Therapeutics, Inc. – 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. Retrieved 3 October 2020.
- ^ "Tegsedi- inotersen injection, solution". DailyMed. 2 September 2020. Retrieved 3 October 2020.
- ^ a b "Tegsedi EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 3 October 2020.
- ^ a b c d e f g h i j k "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.
- S2CID 56178847.
- PMID 32286934.
- ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
- ^ "Inotersen Orphan Drug Designation and Approval". U.S. Food and Drug Administration (FDA). 24 July 2012. 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.
External links
- "Inotersen". Drug Information Portal. U.S. National Library of Medicine (NLM).
