Source: FDA, National Drug Code (US) Revision Year: 2020
Inotersen is an antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) protein synthesis.
TEGSEDI contains inotersen sodium as the active ingredient. Inotersen sodium is a white to pale yellow solid and it is freely soluble in water and in phosphate buffer (pH 7.5 to 8.5).
The chemical name of inotersen sodium is DNA, d(Pthio)([2'O]m5rU[2'O(2-methoxyethyl)]m5rC-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)]rG-G-T-T-A-m5C-A-T-G-A-A-[2'O(2-methoxyethyl)]rA-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)]m5rC-[2'O(2-methoxyethyl)]m5rC-[2'O(2-methoxyethyl)]m5rC).
The molecular formula of inotersen sodium is C230H299N69Na19O121P19S19 and the molecular weight is 7600.73 Da.
It has the following structural formula:
The molecular formula of inotersen free base is C230H318N69O121P19S19 and its molecular weight is 7183.08.
TEGSEDI is a sterile, preservative-free, aqueous solution for subcutaneous injection. It is supplied in a prefilled syringe (PFS). Each PFS contains 1.5 mL of solution containing 284 mg inotersen (equivalent to 300 mg inotersen sodium salt) TEGSEDI is formulated in Water for Injection and may include hydrochloric acid and/or sodium hydroxide for pH adjustment to 7.5-8.5.
| Dosage Forms and Strengths |
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Injection: 284 mg/1.5 mL clear, colorless to pale yellow solution in a single-dose prefilled syringe. |
| How Supplied |
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TEGSEDI is a clear, colorless to pale yellow solution supplied in a single-dose, prefilled syringe with a SSD. Each prefilled syringe of TEGSEDI is filled to deliver 1.5 mL of solution containing 284 mg of inotersen (equivalent to 300 mg inotersen sodium salt). TEGSEDI is available in cartons containing 1 or 4 prefilled syringes supplied in individual trays.
The individual tray of 1 syringe is NDC 72126-007-02. PharmacyStore refrigerated at 2°C to 8°C (36°F to 46°F) in the original container and protect from direct light. Do not freeze. For Patients/CaregiversStore refrigerated at 2°C to 8°C (36°F to 46°F) in the original container. Do not freeze. TEGSEDI can be kept at room temperature (up to 30°C [86°F]) in the original container for up to 6 weeks; if not used within the 6 weeks, discard TEGSEDI. Remove from refrigerated storage (2°C to 8°C [36°F to 46°F]) at least 30 minutes before use. [TEGSEDI] prefilled syringe should be allowed to reach room temperature prior to injection. Avoid exposure to temperatures above 30°C (86°F). |
| Drug | Countries | |
|---|---|---|
| TEGSEDI | Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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