Description
Tegsedi contains inotersen, an antisense oligonucleotide that inhibits the hepatic production of transthyretin (TTR). It is indicated for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy. hATTR is a rare, progressive condition caused by mutations in the TTR gene, leading to accumulation of misfolded amyloid deposits in nerves and organs. Tegsedi reduces serum TTR protein levels, thereby slowing disease progression and improving neurologic function and quality of life in affected individuals.
| F act Table |
| Formula | C230H305N67O122P19S19 |
| License | US FDA (2018), EMA |
| Bioavailability | ~79% (subcutaneous) |
| Legal status | Prescription only (Rx); Orphan drug |
| Chemical Name | Inotersen |
| Elimination half-life | ~30 days |
| Dosage (Strength) | 284 mg once weekly by subcutaneous injection |
| Pregnancy | Use only if clearly needed (Category not assigned; animal studies show risk) |
| Brands | Tegsedi |
| Protein binding | >94% |
| PubChem CID | 121304016 |
| MedlinePlus | a619055 |
| ChEBI | 182483 |
| ATC code | N07XX14 |
| DrugBank | DB15063 |
| KEGG | D11052 |
| Routes of administration | Subcutaneous |
Directions
Tegsedi is administered by subcutaneous injection at a dose of 284 mg once weekly. It should be injected into the abdomen, thigh, or upper arm, rotating sites with each dose. Laboratory monitoring is essential prior to initiation and during treatment, including platelet counts, renal function (serum creatinine and urine protein), and liver function tests. Patients or caregivers may be trained for at-home administration, or the injections can be administered in a healthcare setting.
Ingredients
Each prefilled syringe of Tegsedi contains 284 mg of inotersen in 1.5 mL of solution. Inactive ingredients include water for injection, and it is preservative-free. The formulation is designed for single-use subcutaneous injection.
Contraindications
Tegsedi is contraindicated in patients with a platelet count below 100 × 10?/L, a history of thrombocytopenia associated with anti-platelet antibodies, or acute glomerulonephritis. It is also contraindicated in patients with known hypersensitivity to inotersen or any component of the formulation.
Cautions
Serious risks associated with Tegsedi include thrombocytopenia and glomerulonephritis, which may be life-threatening. Therefore, treatment requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program. Regular laboratory monitoring is critical. Use caution in patients with pre-existing bleeding disorders or renal impairment. Discontinue use if clinically significant bleeding, kidney dysfunction, or hypersensitivity reactions occur. Tegsedi is not recommended during pregnancy or breastfeeding unless the benefits clearly outweigh the risks.
Side Effects
Common side effects may include:
- Thrombocytopenia (can be severe or life-threatening)
Patients should be advised to report signs of unusual bleeding, edema, decreased urine output, or signs of infection immediately.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 14202
Prescription Required