For: Amyloidogenic Transthyretin Amyloidosis
Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. 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.
Pack of 1 prefilled syringe: NDC 72126-007-03
Pack of 4 prefilled syringes: NDC 72126-007-01
The individual tray of 1 syringe is NDC 72126-007-02.
Pharmacy
Store 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/Caregivers
Store 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). These highlights do not include all the information needed to use TEGSEDI� safely and effectively. See full prescribing information for TEGSEDI.
TEGSEDI (inotersen) injection, for subcutaneous use
Initial U.S. Approval: 2018
WARNING: THROMBOCYTOPENIA AND GLOMERULONEPHRITIS
See full prescribing information for complete boxed warning.
Thrombocytopenia
TEGSEDI causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia, which can be life-threatening. (5.1)
Testing prior to treatment and monitoring during treatment is required (2.3, 2.4, 5.1)
Glomerulonephritis
TEGSEDI can cause glomerulonephritis that may require immunosuppressive treatment and may result in dialysis-dependent renal failure. (5.2)
Testing prior to treatment and monitoring during treatment is required (2.3, 2.4, 5.2)
TEGSEDI is available only through a restricted distribution program called the TEGSEDI REMS Program (5.3).
RECENT MAJOR CHANGES
Dosage and Administration, Laboratory Testing and Monitoring to Assess Safety after Initiating TEGSEDI (2.4) 10/2019
Warnings and Precautions, Liver Injury (5.6) 10/2019
INDICATIONS AND USAGE
TEGSEDI is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (1).
DOSAGE AND ADMINISTRATION
The recommended dosage is 284 mg administered by subcutaneous injection once weekly. (2.1)
Laboratory tests must be measured prior to treatment, continue to be monitored after treatment initiation, and for 8 weeks following discontinuation of treatment, as directed. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 284 mg/ 1.5 mL in a single-dose prefilled syringe (3)
CONTRAINDICATIONS
Platelet count less than 100 x 109/L (4, 5.1)
History of acute glomerulonephritis caused by TEGSEDI (4, 5.2)
Patients with a history of a hypersensitivity reaction to TEGSEDI (4, 5.7)
WARNINGS AND PRECAUTIONS
Stroke and Cervicocephalic Arterial Dissection: These adverse events occurred within 2 days of first dose and with symptoms of cytokine release. Educate patients on symptoms of stroke and central nervous system arterial dissection. (5.4)
Inflammatory and Immune Effects: Serious neurologic adverse reactions consistent with inflammatory and immune effects occurred. (5.5)
Liver Injury: Monitor alanine amino transferase, aspartate aminotransferase, and total bilirubin every 4 months during treatment and in case of symptoms of hepatic dysfunction. (5.6)
Hypersensitivity Reactions: If these occur, discontinue and initiate appropriate therapy. (5.7)
Uninterpretable Platelet Counts: Reaction between Antiplatelet Antibodies and ethylenediaminetetra-acetic acid: Platelet clumping can cause uninterpretable platelet measurement; repeat test if thisis suspected. (5.8)
Reduced Serum Vitamin A Levels and Recommended Supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur. (5.9)
ADVERSE REACTIONS
The most common adverse reactions (those that occurred in at least 20% of TEGSEDI-treated patients and more frequently than on placebo) were injection site reactions, nausea, headache, fatigue, thrombocytopenia, and fever (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Akcea Therapeutics, Inc. at 1-833-642-5232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 10/2019
