Inotersen Brand Name– Tegsedi
What is Inotersen
Inotersen is a parenteral transthyretin-directed antisense oligonucleotide indicated for the treatment of polyneuropathy due to hereditary transthyretin-mediated amyloidosis (hATTR) in adults.
In a randomized, placebo-controlled trial, inotersen-treated patients with stage 1 or 2 hereditary transthyretin amyloidosis with polyneuropathy experienced significant improvements in the modified Neuropathy Impairment Score +7 (mNIS+7) and the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) total score at week 66 after 15 months of treatment compared to patients who received placebo. The difference in the least-squares mean (95% CI) between the 2 groups was -19.7 (-26.4, -13; p less than 0.001) for mNIS+7 and -11.7 (-18.3, -5.1; p less than 0.001) for Norfolk QoL-DN. Improvements in these scores reflect gains in physiological outcomes (e.g., muscle strength, reflexes, sensation) and functional outcomes (e.g., walking, nutritional status, and performance of activities of daily living) with inotersen treatment.
Serious adverse reactions including thrombocytopenia, glomerulonephritis, and kidney failure may occur.
Prescribers, pharmacies, and patients must be registered with the Tegsedi REMs program. Patients must comply with blood tests to check platelet counts and kidney function, as well as routine urine testing. More information is available at www.TEGSEDIrems.com
Indications
- amyloidosis-associated polyneuropathy
- Measure platelet count, serum creatinine, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR), ALT, AST, and total bilirubin, and perform urinalysis before treatment with inotersen.
- Do not initiate inotersen in patients with a platelet count less than 100,000 per microliter.
- Generally, do not initiate inotersen in patients with UPCR of 1,000 mg/g or more.
- Monitor platelet count weekly or more frequently depending on actual count. Monitor serum creatinine, eGFR, urinalysis, and UPCR every 2 weeks and ALT, AST, and total bilirubin every 4 months during inotersen treatment. Monitor liver function tests monthly in patients with a history of liver transplant.
- Continue laboratory monitoring for 8 weeks after inotersen discontinuation.
For the treatment of hereditary transthyretin amyloidosis-associated polyneuropathy
Side Effects
- anemia
- antibody formation
- arthralgia
- atrial fibrillation
- atrial flutter
- biliary obstruction
- bleeding
- bradycardia
- chest pain (unspecified)
- chills
- conjunctivitis
- cystitis
- dysphagia
- dyspnea
- ecchymosis
- edema
- elevated hepatic enzymes
- eosinophilia
- erythema
- fatigue
- fever
- flushing
- gastritis
- glomerulonephritis
- headache
- hematoma
- hepatitis
- hypertension
- infection
- influenza
- injection site reaction
- myalgia
- nausea
- nephrotic syndrome
- organ transplant rejection
- paresis
- paresthesias
- peripheral edema
- pruritus
- rash
- sinus tachycardia
- stroke
- syncope
- thrombocytopenia
- thrombocytopenia
- urticaria
- vasculitis
- vomiting
- xerostomia
Monitoring Parameters
- LFTs
- platelet count
- serum creatinine
Contraindications
- breast-feeding
- glomerulonephritis
- pregnancy
- thrombocytopenia
- vitamin A deficiency
Interactions
- Abciximab
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acyclovir
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- Adenosine
- ADP receptor antagonists
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Aliskiren; Hydrochlorothiazide, HCTZ
- Amikacin
- Amiloride
- Amiloride; Hydrochlorothiazide, HCTZ
- Aminoglycosides
- Aminosalicylate sodium, Aminosalicylic acid
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amphotericin B
- Amphotericin B cholesteryl sulfate complex (ABCD)
- Amphotericin B lipid complex (ABLC)
- Amphotericin B liposomal (LAmB)
- Anagrelide
- Anticoagulants
- Antithrombin III
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- Aspirin, ASA; Butalbital; Caffeine
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- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Dipyridamole
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Oxycodone
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- Atenolol; Chlorthalidone
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- Bacitracin
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- Bendroflumethiazide; Nadolol
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- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Bisoprolol; Hydrochlorothiazide, HCTZ
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- Edoxaban
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- Gentamicin
- Heparin
- Hydralazine; Hydrochlorothiazide, HCTZ
- Hydrochlorothiazide, HCTZ
- Hydrochlorothiazide, HCTZ; Irbesartan
- Hydrochlorothiazide, HCTZ; Lisinopril
- Hydrochlorothiazide, HCTZ; Losartan
- Hydrochlorothiazide, HCTZ; Methyldopa
- Hydrochlorothiazide, HCTZ; Metoprolol
- Hydrochlorothiazide, HCTZ; Moexipril
- Hydrochlorothiazide, HCTZ; Olmesartan
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrochlorothiazide, HCTZ; Quinapril
- Hydrochlorothiazide, HCTZ; Spironolactone
- Hydrochlorothiazide, HCTZ; Telmisartan
- Hydrochlorothiazide, HCTZ; Triamterene
- Hydrochlorothiazide, HCTZ; Valsartan
- Hydrocodone; Ibuprofen
- Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
- Ibuprofen
- Ibuprofen; Oxycodone
- Ibuprofen; Pseudoephedrine
- Indapamide
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