Inotersen: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 20, 2026🚩 Report this page

Inotersen

Other Nervous System Drugs

Sold as Tegsedi

GB MHRAEU EMA

Drug class: Other Nervous System Drugs
Availability: See label
Markets covered: 2
Products on record: 2

Overview

Inotersen is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	February 20, 2026
EU European Union	EMA	1	January 17, 2024

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised February 20, 2026[1]

Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 17, 2024[2]

Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

How to take

Drug interactions

Known interactions involving Inotersen. Select one for details. This list is informational and not a complete interaction checker.

Abciximab Acalabrutinib Acyclovir Aldesleukin Alteplase Amikacin Amphotericin B Anagrelide Anisindione Anistreplase Apixaban Ardeparin Argatroban Aspirin Avapritinib Bacitracin Balsalazide Betrixaban Binimetinib Bivalirudin Bromfenac Cabozantinib Cangrelor Caplacizumab Capreomycin Carboplatin Celecoxib Cidofovir Cilostazol Cisplatin Clofarabine Clopidogrel Cyclophosphamide Cyclosporine Dalteparin Danaparoid Dasatinib Deferasirox Deferoxamine Defibrotide Desirudin Diatrizoate Diclofenac Dicumarol Diflunisal Dipyridamole Drotrecogin Alfa Edoxaban Encorafenib Enoxaparin Epoprostenol Eptifibatide Etodolac Everolimus Fedratinib Fenoprofen Flurbiprofen Fondaparinux Foscarnet Ganciclovir Gentamicin Givosiran Heparin Ibandronate Ibritumomab Tiuxetan Ibrutinib Ibuprofen Ifosfamide Iloprost Indomethacin Iodipamide Iodixanol Iohexol Iopamidol Iopromide Iothalamic Acid Ioversol Ioxilan Kanamycin Ketoprofen Ketorolac Leflunomide Lepirudin Lithium Carbonate Lomitapide Meclofenamic Acid Mefenamate Meloxicam Mesalamine Methotrexate Methoxyflurane Mipomersen Moxetumomab Pasudotox Nabumetone Naproxen Neomycin Netilmicin Olsalazine Omacetaxine Mepesuccinate Oxaprozin Pamidronate Panobinostat Penicillamine Pentamidine Pentoxifylline Phenylbutazone Piroxicam Plazomicin Plicamycin Polymyxin B Ponatinib Prasugrel Ramucirumab Regorafenib Reteplase Rivaroxaban Rofecoxib Ruxolitinib Salsalate Sirolimus Streptokinase Streptomycin Streptozocin Sulfasalazine Sulfinpyrazone Sulindac Tacrolimus Tazemetostat Telavancin Temsirolimus Tenecteplase Teriflunomide Ticagrelor Ticlopidine Tinzaparin Tipranavir Tirofiban Tobramycin Tolmetin Tositumomab Treprostinil Urokinase Valacyclovir Valdecoxib Valganciclovir Vancomycin Vorapaxar Warfarin Zanubrutinib Zoledronic Acid Bedaquiline Brentuximab Vedotin Cannabidiol Citalopram Clomipramine Desvenlafaxine Dexfenfluramine Duloxetine Efavirenz Entecavir Epirubicin Escitalopram Exenatide Fenfluramine Flucytosine Fluoxetine Fluvoxamine Hemin Idelalisib Interferon Beta-1a Interferon Beta-1b Levomilnacipran Milnacipran Naltrexone Nepafenac Oxaliplatin Paroxetine Peginterferon Beta-1a Pemetrexed Pentosan Polysulfate Remdesivir Sertraline Sibutramine Suprofen Telbivudine Thioguanine Trabectedin Venlafaxine Vilazodone Vortioxetine

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB517040002 · revised February 20, 2026
[2]European Medicines Agency · EMEA/H/C/004782 · revised January 17, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with hereditary transthyretin amyloidosis. Posology The recommended dose is 284 mg inotersen by subcutaneous injection.
Doses should be administered once every week. For consistency of dosing, patients should be instructed to receive the injection on the same day every week. Dose adjustment in case of reduction in platelet count Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia.
Dosing should be adjusted according to laboratory values as follows:
Table 1. Inotersen monitoring and dosing recommendations according to platelet count Platelet count (x109/L) Monitoring frequency Dosing > 100 Every 2 weeks Weekly dosing should be continued. ≥ 75 to < 100* Every week Dosing frequency should be reduced to 284 mg every 2 weeks < 75* Twice weekly until 3 successive values above 75 then weekly monitoring.
Dosing should be paused until 3 successive values > 100. On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks. < 50‡† Twice weekly until 3 successive values above 75 then weekly monitoring. More frequent monitoring should be considered if additional risk factors for bleeding are present.
Dosing should be paused until 3 successive values > 100. On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks. Corticosteroids should be considered if additional risk factors for bleeding are present.
< 25† Daily until 2 successive values above 25. Then twice weekly monitoring until 3 successive values above 75. Then weekly monitoring until stable. Treatment should be discontinued. Corticosteroids recommended. * If the subsequent test confirms the initial test result, then monitoring frequency and dosing should be adjusted as recommended in the table.
‡ Additional risk factors for bleeding include age > 60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events. † It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline.
Patients who discontinue therapy with inotersen due to platelet counts below 25 x 109/L should not reinitiate therapy. Missed doses If a dose of inotersen is missed, then the next dose should be administered as soon as possible, unless the next scheduled dose is within two days, in which case the missed dose should be skipped and the next dose administered as scheduled.
2). 2). 3). 4). If acute glomerulonephritis is confirmed, permanent discontinuation of the treatment should be considered. 2). 3). Patients undergoing liver transplant Inotersen has not been evaluated in patients undergoing liver transplant.
It is, therefore, recommended that inotersen should be discontinued in subjects undergoing liver transplantation. Paediatric population The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established.
No data are available. Method of administration Subcutaneous use only. Each pre-filled syringe is for one-time use only. The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Patients and/or caregivers should be trained in the subcutaneous administration of Tegsedi. Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm. It is important to rotate sites for injection. If injected in the upper arm, the injection should be administered by another person.
Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur. Tegsedi should not be injected into areas of skin disease or injury. Tattoos and scars should also be avoided. The pre-filled syringe should be allowed to reach room temperature prior to injection.
It should be removed from refrigerated storage at least 30 minutes before use. Other warming methods should not be used.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]

9%). 7%). Tabulated summary of adverse reactions Table 2 presents the adverse drug reactions (ADRs) listed by MedDRA system organ class. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from the available data).
Table 2. List of adverse reactions in clinical studies and post-marketing sources System Organ Class Very Common Common Uncommon Not known Blood and lymphatic system disorders Thrombocytopenia Anaemia Platelet count decreased Eosinophilia Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite Nervous system disorders Headache Vascular disorders Orthostatic hypotension Hypotension Haematoma Gastrointestinal disorders Vomiting Nausea Hepatobiliary disorders Transaminases increased Drug- induced liver injury Skin and subcutaneous disorders Pruritus Rash Renal and urinary disorders Glomerulonephritis Proteinuria Renal failure Acute kidney injury Renal impairment General disorders and administration site conditions Pyrexia Chills Injection site reactions Influenza like illness Peripheral swelling Injection site System Organ Class Very Common Common Uncommon Not known Peripheral oedema discolouration Injury, poisoning and procedural complications Contusion Description of selected adverse reactions Injection site reactions The most frequently observed events included those associated with injection site reactions (injection site pain, erythema, pruritus, swelling, rash, induration, bruising and haemorrhage).
These events are usually either self-limiting or can be managed using symptomatic treatment. Thrombocytopenia Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia. 7% of inotersen-treated patients.
Three (3%) patients developed platelet counts < 25 x 109/L; one of these patients experienced a fatal intracranial haemorrhage. 4). 4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment.
Development of anti-drug antibodies to inotersen was characterised by late onset (median onset > 200 days) and low titer (median peak titer of 284 in the pivotal study). No effect on the pharmacokinetic properties (maximum plasma concentration (Cmax), area under the curve (AUC) or half-life) and efficacy of inotersen was observed in the presence of anti-drug antibodies, but patients with anti-drug antibodies had more reactions at the injection site.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]

8). Platelet count should be monitored every 2 weeks during the entire course of treatment with inotersen and for 8 weeks following discontinuation of treatment. 2). g. petechia, spontaneous bruising, subconjunctival bleeding, nosebleeds, bleeding from the gums, blood in urine or stools, bleeding in the whites of eyes), neck stiffness or atypical severe headache because these symptoms may be caused by bleeding in the brain.
5), and in patients with prior history of major bleeding events. 8). 8). UPCR and eGFR should be monitored every 3 months or more frequently, as clinically indicated, based on history of chronic kidney disease and/or renal amyloidosis.
UPCR and eGFR should be monitored for 8 weeks following discontinuation of treatment. Patients with UPCR more than or equal to twice the upper limit of normal, or eGFR < 60 ml/min, which is confirmed on repeat testing and in the absence of an alternative explanation, should be monitored every 4 weeks.
In the case of a decrease in eGFR > 30%, in the absence of an alternative explanation, pausing of inotersen dosing should be considered pending further evaluation of the cause. In the case of UPCR ≥ 2 g/g (226 mg/mmol), which is confirmed on repeat testing, dosing of inotersen should be paused while further evaluation for acute glomerulonephritis is performed.
Inotersen should permanently be discontinued if acute glomerulonephritis is confirmed. 3). Early initiation of immunosuppressive therapy should be considered if a diagnosis of glomerulonephritis is confirmed. 5). 1). Plasma vitamin A (retinol) levels below lower limit of normal should be corrected and any ocular symptoms or signs of vitamin A deficiency should have resolved prior to initiation of inotersen.
Patients receiving inotersen should take oral supplementation of approximately 3 000 IU vitamin A per day in order to reduce the potential risk of ocular toxicity due to vitamin A deficiency. Referral for ophthalmological assessment is recommended if patients develop ocular symptoms consistent with vitamin A deficiency, including: reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening, corneal perforation.
During the first 60 days of pregnancy, both too high and too low vitamin A levels may be associated with an increased risk of foetal malformation. 6). If a woman intends to become pregnant, inotersen and vitamin A supplementation should be discontinued and plasma vitamin A levels should be monitored and have returned to normal before conception is attempted.

This is not medical advice. Consult a qualified healthcare professional.

Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with hereditary transthyretin amyloidosis. Posology The recommended dose is 284 mg inotersen by subcutaneous injection.
Doses should be administered once every week. For consistency of dosing, patients should be instructed to receive the injection on the same day every week. Dose adjustment in case of reduction in platelet count Inotersen is associated with reductions in platelet count, which may result in thrombocytopenia.
Dosing should be adjusted according to laboratory values as follows:
Table 1 . Inotersen monitoring and dosing recommendations according to platelet count Platelet count (x 109/L) Monitoring frequency Dosing > 100 Every 2 weeks Weekly dosing should be continued. ≥ 75 to < 100* Every week Dosing frequency should be reduced to 284 mg every 2 weeks.
3 < 75* Twice weekly until 3 successive values above 75 then weekly monitoring. Dosing should be paused until 3 successive values > 100. On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks. < 50‡† Twice weekly until 3 successive values above 75 then weekly monitoring.
More frequent monitoring should be considered if additional risk factors for bleeding are present. Dosing should be paused until 3 successive values > 100. On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks.
Corticosteroids should be considered if additional risk factors for bleeding are present. < 25† Daily until 2 successive values above 25. Then twice weekly monitoring until 3 successive values above 75. Then weekly monitoring until stable.
Treatment should be discontinued. Corticosteroids recommended. * If the subsequent test confirms the initial test result, then monitoring frequency and dosing should be adjusted as recommended in the table. ‡ Additional risk factors for bleeding include age > 60 years, receiving anticoagulant or antiplatelet medicinal products, and /or prior history of major bleeding events.
† It is strongly recommended that, unless corticosteroids are contraindicated, the patient receives glucocorticoid therapy to reverse the platelet decline. Patients who discontinue therapy with inotersen due to platelet counts below 25 x 109/L should not reinitiate therapy.
Missed doses If a dose of inotersen is missed, then the next dose should be administered as soon as possible, unless the next scheduled dose is within two days, in which case the missed dose should be skipped and the next dose administered as scheduled.
2). 2). 3). 4). If acute glomerulonephritis is confirmed, permanent discontinuation of the treatment should be considered. 2). 3). Patients undergoing liver transplant Inotersen has not been evaluated in patients undergoing liver transplant.
It is, therefore, recommended that inotersen should be discontinued in subjects undergoing liver transplantation. Paediatric population 4 The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established.
No data are available. Method of administration Subcutaneous use only. Each pre-filled syringe is for one-time use only. The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Patients and/or caregivers should be trained in the subcutaneous administration of Tegsedi. Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm. It is important to rotate sites for injection. If injected in the upper arm, the injection should be administered by another person.
Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur. Tegsedi should not be injected into areas of skin disease or injury. Tattoos and scars should also be avoided. The pre-filled syringe should be allowed to reach room temperature prior to injection.
It should be removed from refrigerated storage at least 30 minutes before use. Other warming methods should not be used.