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Tegsedi

Tegsedi (generic name: inotersen) is an antisense oligonucleotide used to treat adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). This rare genetic condition causes abnormal protein deposits to build up in various organs and tissues, leading to nerve damage, heart problems, and other serious complications. Tegsedi works by reducing the production of the transthyretin (TTR) protein, which helps slow disease progression and alleviate symptoms.



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Frequently Asked Questions

How long does it take for Tegsedi to start working?
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Tegsedi may take several months to show significant improvement in symptoms. Regular follow-up visits with your doctor are necessary to monitor your response to the treatment.

Can I take Tegsedi if I have kidney problems?
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Tegsedi can affect kidney function, so patients with pre-existing kidney problems should be closely monitored. Your doctor will assess the risks and may adjust your treatment accordingly.

What should I do if I miss a dose of Tegsedi?
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If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next scheduled dose. Do not take two doses at once.

How is Tegsedi stored?
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Store Tegsedi in the refrigerator and allow it to reach room temperature before injecting. Do not freeze or shake the syringe.

How often do I need blood tests while on Tegsedi?
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Blood tests to monitor platelet counts and kidney function are required every week during treatment. These tests are critical to ensure the medication is safe and effective for you.

Comprehensive Drug Guide

How Does Tegsedi Work?

Tegsedi works by binding to the messenger RNA (mRNA) that codes for the production of the transthyretin (TTR) protein. By preventing the production of TTR, Tegsedi helps reduce the amount of abnormal protein that forms amyloid deposits in the body, slowing the progression of the disease and improving symptoms.



Common Dosages

Tegsedi is available as a pre-filled syringe containing 284 mg/1.5 mL of inotersen.

Typical Dosing

  • For hATTR amyloidosis: The typical dose is 284 mg (one syringe) injected subcutaneously once weekly. Patients should be regularly monitored for platelet counts and kidney function during treatment.


Typical Dosing

FDA Approved Indications

  • Hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with polyneuropathy.


Who Shouldn't Take Tegsedi?

  • Severe thrombocytopenia (low platelet count)
  • Acute glomerulonephritis (a type of kidney inflammation)
  • Known hypersensitivity to inotersen or any component of the formulation


Advice From The Pharmacist

  • Administer Tegsedi once weekly via subcutaneous injection. Your healthcare provider will train you on how to properly administer the injection at home.
  • Monitor for signs of low platelet count, such as unusual bruising, bleeding, or petechiae (tiny red spots under the skin). Regular blood tests will be required to check your platelet levels and kidney function.
  • Store Tegsedi in the refrigerator, and allow it to reach room temperature for about 30 minutes before injecting. Do not freeze or shake the syringe.
  • If you miss a dose, inject it as soon as you remember, unless it’s close to the time of your next dose. Do not double the dose.


Side Effects of Tegsedi

Common Side Effects

  • Injection site reactions (redness, swelling, pain)
  • Nausea
  • Headache
  • Fatigue
  • Thrombocytopenia (low platelet count)


Uncommon/Severe Side Effects

  • Thrombocytopenia, which can increase the risk of severe bleeding
  • Glomerulonephritis and other kidney problems
  • Severe allergic reactions (anaphylaxis)


Risks and Warnings of Tegsedi

  • Thrombocytopenia: Tegsedi can cause a dangerous drop in platelets, increasing the risk of bleeding. Regular monitoring of platelet counts is essential, and treatment may need to be paused or stopped if platelet levels fall too low.
  • Kidney Damage: Tegsedi can cause kidney problems, including glomerulonephritis. Patients should have regular blood tests to monitor kidney function, and any signs of worsening kidney disease should be addressed immediately.
  • Severe Allergic Reactions: In rare cases, Tegsedi can cause severe allergic reactions, including anaphylaxis. If you experience difficulty breathing, swelling of the face or throat, or a rash, seek immediate medical attention.


Interactions with Tegsedi

Common Drug Interactions

  • Anticoagulants and blood thinners: Tegsedi can increase the risk of bleeding, especially when combined with blood thinners like warfarin or aspirin. Regular monitoring of platelet levels is necessary.
  • Nephrotoxic drugs: Avoid using Tegsedi with medications that can harm the kidneys, such as certain antibiotics (e.g., aminoglycosides) or NSAIDs, as this may increase the risk of kidney damage.


Alternatives to Tegsedi

  • Onpattro (patisiran): Another medication used to treat hATTR amyloidosis by reducing the levels of transthyretin protein.
  • Vyndaqel (tafamidis): An oral medication used to treat hATTR amyloidosis by stabilizing the TTR protein, preventing it from forming amyloid deposits.
  • Liver transplant: In some cases of hATTR amyloidosis, liver transplantation may be considered to stop the production of abnormal TTR protein.