Tegsedi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Tegsedi Indications
Indications
Tegsedi Dosage and Administration
Adult
Children
Administration
Tegsedi Contraindications
Contraindications
Platelet count <100×109/L. History of acute glomerulonephritis due to Tegsedi.
Tegsedi Boxed Warnings
Boxed Warning
Tegsedi Warnings/Precautions
Warnings/Precautions
Risk of thrombocytopenia, glomerulonephritis. Do not initiate if platelets <100×109/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, monthly during (esp. with history of liver transplant), and for 8 weeks after discontinuation. Discontinue if liver injury 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
Absorption
Median time to maximum plasma concentrations: 2–4 hours.
Distribution
Apparent volume of distribution (at steady-state): 293 L. Plasma protein bound: >94%.
Elimination
Half-life: 32.3 days. Clearance: 3.18 L/h.
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 <50×109/L. Caution with concomitant nephrotoxic drugs or drugs that may impair renal function.
Tegsedi Adverse Reactions
Adverse Reactions
Tegsedi Clinical Trials
See Literature
Tegsedi Note
Not Applicable
Tegsedi Patient Counseling
See Literature