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Tegsedi

Generic Name: inotersen (IN oh TER sen)
Brand Names: Tegsedi
Tegsedi (inotersen) is used to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis. Includes Tegsedi approval status, regulatory history and clinical trial results.
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Drug Information:
Tegsedi (inotersen) works by decreasing a protein called transthyretin (TTR, made primarily in the liver). Hereditary transthyretin-mediated amyloidosis (hATTR) is a rare condition in which abnormal deposits of TTR protein build up in many parts of the body, interfering with normal function. Tegsedi injection is used to treat polyneuropathy (damage of multiple nerves throughout the body) in adults with hATTR. This medicine can help reduce symptoms such as pain, numbness, tingling, abnormal heartbeats, diarrhea, constipation, weakness, and problems with movement in your arms or legs. Learn more

Tegsedi Side Effects

Tegsedi Side Effects

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.

For the Consumer

Applies to inotersen: subcutaneous solution prefilled syringe

Warning

  • This drug can cause low platelet levels. Sometimes, very low platelet levels have led to life-threatening or deadly bleeding problems. If you have questions, talk with the doctor.
  • If you have a low platelet count, talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Call your doctor right away if you have any signs of bleeding problems, like bruising; black, tarry, or bloody stools; bleeding gums; blood in the urine; coughing up blood; cuts that take a long time to stop bleeding; feel dizzy; feeling very tired or weak; nosebleeds; pain or swelling; throwing up blood or throw up that looks like coffee grounds; or very bad headache.
  • Kidney problems have happened with this drug. Sometimes, people have needed dialysis. Kidney problems may be long-lasting. If you have questions, talk with the doctor.
  • If you have kidney disease, talk to your doctor.
  • Have your urine checked as you have been told by your doctor.
  • Call your doctor right away if you have signs of kidney problems like not able to pass urine; change in how much urine is passed; bloody, brown, or foamy urine; shortness of breath or cough; or puffy or swollen face, feet, or hands.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very bad headache.
  • Stiff neck.
  • Trouble walking.
  • Muscle pain or weakness.
  • Muscle spasm.
  • Back pain.
  • Weight loss.
  • Swelling in the arms or legs.
  • Feeling very tired or weak.
  • A heartbeat that does not feel normal.
  • A burning, numbness, or tingling feeling that is not normal.
  • Shortness of breath.
  • Very bad dizziness or passing out.
  • Change in eyesight like trouble seeing at night.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Upset stomach or throwing up.
  • Headache.
  • Feeling tired or weak.
  • Fever.
  • Not hungry.
  • Dry mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

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.

For Healthcare Professionals

Applies to inotersen: subcutaneous solution

General

The more commonly reported adverse reactions have included injection site reactions, nausea, headache, fatigue, thrombocytopenia, and fever.

Hematologic

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

Renal

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

Hypersensitivity

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.

Hepatic

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

Nervous system

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.

Immunologic

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.

Local

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%)

Musculoskeletal

Very common (10% or more): Myalgia (15%), arthralgia (13%)

Metabolic

Common (1% to 10%): Decreased appetite

Respiratory

Common (1% to 10%): Dyspnea

Other

Very common (10% or more): Fatigue (25%), fever (20%), chills (18%)

Cardiovascular

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

Dermatologic

Common (1% to 10%): Contusion

Gastrointestinal

Very common (10% or more): Nausea (31%), vomiting (15%)

Common (1% to 10%): Dry mouth

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Tegsedi