Note: This document contains side effect information about inotersen. Some of the dosage forms listed on this page may not apply to the brand name Tegsedi.
Applies to inotersen: subcutaneous solution prefilled syringe
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You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Applies to inotersen: subcutaneous solution
The more commonly reported adverse reactions have included injection site reactions, nausea, headache, fatigue, thrombocytopenia, and fever.
Sudden and unpredictable platelet count reductions have been reported. Three clinical trial patients had sudden and severe thrombocytopenia with platelet counts below 25 x 10(9)/L. One patient died of a fatal intracranial hemorrhage. All 3 of these patients had treatment-emergent antiplatelet IgG antibodies detected shortly before or at the time of the severe thrombocytopenia. For 2 of these patients, platelet clumping cause by a reaction between antiplatelet antibodies and ethylenediaminetetraacetic acid (EDTA) caused a delay in interpretable platelet measurements which delayed diagnosis and treatment.
Very common (10% or more): Thrombocytopenia (24%), anemia (17%)
Common (1% to 10%): Eosinophilia
Glomerulonephritis was reported in 3 treated patients during clinical trials; glomerulonephritis did not resolve with discontinuation and immunosuppressive therapy was necessary. One patient did not receive immunosuppressive treatment and remained dialysis-dependent.
Nephrotic syndrome was reported as accompanying cases of glomerulonephritis. Tubular proteinuria was reported and attributed to the accumulation of antisense oligonucleotides in the proximal tubule cells of the kidney. UPCR elevations to greater than 5 times the upper limit of normal (5xULN) occurred in 15% of drug treated patients compared to 8% in placebo patients.
Very common (10% or more): Decreased renal function (14%), increased urine protein to creatinine ratio (UPCR; 15%); increased serum creatinine (11%)
Common (1% to 10%): Glomerulonephritis
Frequency not reported: Nephrotic syndrome, tubular proteinuria
Common (1% to 10%): Hypersensitivity reactions
Hypersensitivity reactions have been reported and generally occurred within 2 hours of receiving the drug. Reactions have included headache, chest pain, hypertension, chills, flushing, dysphagia, palmar erythema, eosinophilia, involuntary choreaform movements, arthralgia, myalgia, and flu-like symptoms. Drug antibodies were present when the reactions occurred.
ALT elevations to at least 3 times the upper limit of normal (3 x ULN) occurred in 8% of drug-treated patients compare to 3% of placebo patients; 3% of drug-treated patients had an ALT of 8 x ULN compared to 0% of placebo patients. Some patients had resolution of these ALT elevations with continued therapy.
One case of immune-mediated biliary disease was reported and a single case of autoimmune hepatitis with primary biliary cirrhosis in a patient with a family history of primary biliary cirrhosis.
Common (1% to 10%): ALT elevations
Uncommon (0.1% to 1%): Autoimmune hepatitis with primary biliary cirrhosis; biliary obstruction of unclear etiology
Frequency not reported: Immune-mediated biliary disease
Very common (10% or more): Headache (26%)
Common (1% to 10%): Paresthesia
Uncommon (0.1% to 1%): Carotid artery dissection and stroke; serious neurologic adverse reaction
Neurologic serious reactions consistent with inflammatory and immune effects have occurred. One patient developed a change in gait 2 months after the first dose, it progressed to paraparesis over 6 months. No radiologic evidence of spinal cord compression was found. Another patient developed progressive lumbar pain, weight loss, headache, vomiting, and impaired speech 7 months after starting therapy. Cerebrospinal fluid analysis showed elevated protein, and a lymphocyte-predominant pleocytosis that was negative for infection. This patient recovered after high-dose steroids and antibiotics and resumed therapy.
Very common (10% or more): Anti-drug antibodies
Common (1% to 10%): Influenza-like illness, bacterial infection
Frequency not reported: Immune thrombocytopenia, antineutrophil cytoplasmic autoantibody (ANCA) positive systemic vasculitis
Bacterial infection includes bacteremia, cellulitis staphylococcal, clostridium difficile infection, conjunctivitis bacterial, cystitis Escherichia, Helicobacter gastritis, Helicobacter infection, Staphylococcal infection.
Anti-drug antibodies were present in 30% of patients after 65 weeks of receiving this drug. As with other measures of anti-drug antibodies, the detection is highly dependent on the sensitivity and specificity of the assay. The assay used measured IgG isotypes only; other isotypes may be possible. Anti-drug antibodies were present in many case of adverse reactions, although the data was too limited to make definitive conclusions about the relationship.
Injection site reactions included bruising, erythema, hematoma, hemorrhage, induration, inflammation, mass, edema, pain, pruritus, rash, swelling, and urticaria. Injection site reactions occurred in 49% of patients receiving this drug compared with 10% of placebo patients.
Very common (10% or more): Injection site reactions (49%)
Very common (10% or more): Myalgia (15%), arthralgia (13%)
Common (1% to 10%): Decreased appetite
Common (1% to 10%): Dyspnea
Very common (10% or more): Fatigue (25%), fever (20%), chills (18%)
Arrhythmia included arrhythmia, atrial fibrillation, atrial flutter, bradyarrhythmia, bradycardia, extrasystoles, sinus arrhythmia, sinus bradycardia, supraventricular extrasystoles, tachycardia, and ventricular extrasystoles.
Very common (10% or more): Peripheral edema (19%), arrhythmia (13%), pre-syncope or syncope (13%)
Common (1% to 10%): Orthostasis
Common (1% to 10%): Contusion
Very common (10% or more): Nausea (31%), vomiting (15%)
Common (1% to 10%): Dry mouth
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Tegsedi