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Tegsedi

Last reviewed on RxList: 5/26/2020
Tegsedi Side Effects Center

What Is Tegsedi?

Tegsedi (inotersen) is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

What Are Side Effects of Tegsedi?

Common side effects of Tegsedi include injection site reactions, icluding:

  • bruising,
  • redness,
  • a hard lump,
  • inflammation,
  • swelling,
  • pain,
  • itching,
  • rash,
  • hives

Side effects may also include:

Dosage for Tegsedi

The recommended dosage of Tegsedi is 284 mg administered by subcutaneous injection once weekly.

What Drugs, Substances, or Supplements Interact with Tegsedi?

Tegsedi may interact with:

  • antiplatelet drugs,
  • aspirin,
  • nonsteroidal anti-inflammatory drugs (NSAIDs),
  • anticoagulants, and
  • nephrotoxic drugs and other drugs that may impair renal function.

Tell your doctor all medications and supplements you use.

Tegsedi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tegsedi. Tegsedi treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking Tegsedi. Vitamin A levels should be monitored in pregnant women taking Tegsedi. It is unknown if Tegsedi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tegsedi (inotersen) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tegsedi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding (from your nose, gums, or a cut), purple or red spots under your skin;
  • severe headache, neck stiffness;
  • sudden numbness or weakness (especially on one side of the body);
  • slurred speech, drooping eyelids, problems with vision or balance;
  • bloody or tarry stools;
  • blood in your urine, urine that looks foamy, little or no urination;
  • cough with bloody mucus or vomit that looks like coffee grounds;
  • bleeding in the whites of your eyes;
  • heavy menstrual bleeding;
  • puffy eyes, swelling in your hands or feet, shortness of breath;
  • nausea, vomiting, muscle pain, muscle weakness; or
  • a reaction within 2 hours after an injection--headache, chest pain, flu-like symptoms, warmth or chills, redness on the palms of your hands, muscle or joint pain, uncontrolled muscle movements.

Common side effects may include:

  • low platelets;
  • nausea;
  • fever;
  • headache; or
  • pain, swelling, itching, bruising, redness, bleeding, or a hard lump where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tegsedi (Inotersen Injection)

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Tegsedi Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Glomerulonephritis and Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Stroke and Cervicocephalic Arterial Dissection [see WARNINGS AND PRECAUTIONS]
  • Inflammatory and Immune Effects [see WARNINGS AND PRECAUTIONS]
  • Liver Injury[see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]
  • Reducted Serum Vitamin A Levels and Recommended Supplementation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of TEGSEDI cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

A total of 112 adult patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR) received TEGSEDI in Study 1 and 60 patients received placebo. The, mean age of the study patients was 59 years (27 to 78 years of age). Of the TEGSEDI-treated patients, 69% were male and 94% were Caucasian, with a mean exposure of 385 days, and median exposure of 449 days. Baseline disease characteristics were largely similar in TEGSEDI-treated patients and patients in the placebo control group. Sixty-seven percent of patients were in Stage 1 of the disease at baseline, and 33% in Stage 2. Fifty-two percent of patients had Val30Met mutations in the TTR gene, with the remaining 48% comprised of 26 different other point mutations.

Table 2 presents common adverse reactions that occurred in at least 5% of TEGSEDI-treated patients and that occurred at least 5% more frequently or two times more frequently than on placebo.

The most common adverse reactions 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. Serious adverse reactions were more frequent in TEGSEDI-treated patients (32%) than in patients on placebo (21%). The most common adverse reactions leading to discontinuation were thrombocytopenia and cachexia.

Table 2: Adverse Reactions Reported in At Least 5% TEGSEDI-Treated Patients and that Occurred At Least 5% More Frequently or At Least Two Times More Frequently than Placebo Patients (Study 1)

TEGSEDI
(N=112) %
Placebo
(N=60) %
Injection site reactionsa4910
Nausea3112
Headache2612
Fatigue2520
Thrombocytopenia242
Fever208
Peripheral edema1910
Chills183
Anemia173
Vomiting155
Myalgia1510
Decreased renal function145
Arrhythmiab135
Arthralgia138
Pre-syncope or syncope135
Decreased appetite100
Paresthesia103
Dyspnea93
Elevated liver function test93
Orthostasis82
Influenza like illness83
Contusion72
Bacterial infectionc73
Eosinophilia50
Dry mouth52
a Includes bruising, erythema, hematoma, hemorrhage, induration, inflammation, mass, edema, pain, pruritus, rash, swelling, and urticaria.
b Includes arrhythmia, atrial fibrillation, atrial flutter, bradyarrhythmia, bradycardia, extrasystoles, sinus arrhythmia, sinus bradycardia, supraventricular extrasystoles, tachycardia, and ventricular extrasystoles.
c Includes bacteremia, cellulitis staphylococcal, clostridium difficile infection, conjunctivitis bacterial, cystitis Escherichia, Helicobacter gastritis, Helicobacter infection, Staphylococcal infection.

Immunogenicity

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. In addition, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to TEGSEDI in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In Study 1, 30% of TEGSEDI-treated patients tested positive for anti-drug antibodies (ADA) following 65 weeks of treatment [see WARNINGS AND PRECAUTIONS]. However, the assay measured only IgG isotypes and the existence of other isotypes may be possible. In many cases adverse reactions occurred in patients with ADA, although the available data are too limited to make definitive conclusions about the relationship.

Read the entire FDA prescribing information for Tegsedi (Inotersen Injection)

Related Resources for Tegsedi

Related Health

© Tegsedi Patient Information is supplied by Cerner Multum, Inc. and Tegsedi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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