Tegsedi Generic Name & Formulations
Legal Class
Rx
General Description
Inotersen 284mg/1.5mL; soln for SC inj; preservative-free.
Pharmacological Class
Antisense oligonucleotide.
How Supplied
Single-dose prefilled syringes—1, 4
Manufacturer
Generic Availability
NO
Tegsedi Indications
Indications
Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Tegsedi Dosage and Administration
Adult
Give as SC inj in abdomen, upper thigh, or outer area of upper arm; rotate inj sites. 284mg once weekly. Monitoring and treatment recommendations: see full labeling.
Children
Not established.
Tegsedi Contraindications
Contraindications
Platelet count <100x109/L. History of acute glomerulonephritis due to Tegsedi.
Tegsedi Boxed Warnings
Boxed Warning
Thrombocytopenia. Glomerulonephritis.
Tegsedi Warnings/Precautions
Warnings/Precautions
Risk of thrombocytopenia, glomerulonephritis. Do not initiate if platelets <100x109/L or UPCR ≥1000mg/g; discontinue and/or give corticosteroids (based on platelet count) or immunosuppressants; see full labeling. Avoid Tegsedi therapy if glucocorticoids or immunosuppressants are not advised. Monitor platelets, serum creatinine, eGFR, urine protein to creatinine ratio (UPCR), and urinalysis prior to treatment, every 2 weeks during, and for 8 weeks after discontinuation. Perform repeat platelet count if EDTA-mediated platelet clumping is suspected. Withhold if UPCR ≥1000mg/g or eGFR <45mL/min/1.73m2 develops; may resume treatment once resolved. Permanently discontinue if acute glomerulonephritis is confirmed. Nephrotic syndrome. Monitor ALT/AST, and total bilirubin prior to treatment, every 4 months during (monthly in liver transplant recipients), and for 8 weeks after discontinuation. Interrupt or discontinue if hepatic dysfunction or signs of liver transplant rejection develop. Risk of stroke and CNS arterial dissection. Discontinue if hypersensitivity reaction occurs. Give recommended Vit. A supplementation; refer for eye exam if symptoms of Vit. A deficiency (eg, night blindness). Moderate or severe hepatic impairment, severe renal impairment or ESRD: not studied. Elderly. Pregnancy. Nursing mothers.
REMS
Tegsedi Pharmacokinetics
See Literature
Tegsedi Interactions
Interactions
Thrombocytopenia risk with concomitant antiplatelets (eg, adenosine, clopidogrel, prasugrel, ticagrelor, ticlopidine, aspirin, NSAIDs) or anticoagulants (eg, heparin, warfarin); consider discontinuing these agents if platelets <50x109/L. Caution with concomitant nephrotoxic drugs or drugs that may impair renal function.
Tegsedi Adverse Reactions
Adverse Reactions
Inj site reactions, nausea, headache, fatigue, thrombocytopenia, fever; glomerulonephritis, renal toxicity, inflammatory/immune effects, hepatic effects, hypersensitivity, reduced serum Vit. A.
Tegsedi Clinical Trials
See Literature
Tegsedi Note
Not Applicable
Tegsedi Patient Counseling
See Literature