Drug Action
Inotersen is an antisense oligonucleotide inhibitor which inhibits transthyretin production.
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Drug reference
Inotersen is an antisense oligonucleotide inhibitor which inhibits transthyretin production.
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Stage 1 or stage 2 polyneuropathy in patients with hereditary transthyretin amyloidosis (hATTR) (initiated by a specialist) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 284 mg once weekly, for dose adjustments due to side-effects and information on Vitamin A supplementation—consult product literature
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Patients undergoing liver transplantation (no information available). platelet count less than 100x109/litre before starting treatment. urine protein to creatinine ratio (UPCR) greater than or equal to 113 mg/mmol before starting treatment
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Concomitant administration with nephrotoxic drugs. elderly. history of major bleeding
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Manufacturer advises plasma vitamin A levels below the lower limit of normal should be corrected and any ocular symptoms or signs of vitamin A deficiency should have resolved before starting treatment.
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NICE decisions ▶Inotersen for treating hereditary transthyretin amyloidosis (May 2019) NICE HST9 Inotersen is recommended, within its marketing authorisation, as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin Nervous system amyloidosis. It is recommended only if the manufacturer provides inotersen according to the commercial arrangement. www.nice.org.uk/guidance/hst9 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2188 The Scottish Medicines Consortium has advised (August 2019) that inotersen (Tegsedi ®) is accepted for use within NHS Scotland for the treatment of stage 1 or stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis (hATTR). This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: inotersen
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▶Common or very common Anaemia. appetite decreased. Nervous system chills. eosinophilia. fever. glomerulonephritis. haematoma. headache. hypotension. influenza like illness. nausea. peripheral oedema. peripheral swelling. proteinuria. renal impairment. skin reactions. thrombocytopenia. vomiting ▶Frequency not known Intracranial haemorrhage. vitamin A deficiency
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Manufacturer advises women of childbearing potential should use effective contraception during treatment; if conception is planned, inotersen and vitamin A supplementation should be stopped and vitamin A levels monitored—consult product literature.
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Manufacturer advises avoid unless essential (limited information available)—potential teratogenic risk due to unbalanced vitamin A levels, consult product literature.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises avoid in severe impairment (no information available).
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Manufacturer advises avoid if eGFR less than 45 mL/minute/1.73 m2.
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▶Manufacturer advises monitor platelet count before starting treatment, every 2 weeks during treatment, and for 8 weeks after stopping treatment—consult product literature. ▶Manufacturer advises monitor UPCR and eGFR before starting treatment, every 3 months or more frequently as clinically indicated during treatment, and for 8 weeks after stopping treatment—consult product literature. ▶Manufacturer advises monitor hepatic enzymes before starting treatment, then 4 months after starting treatment, and annually thereafter or more frequently as clinically indicated.
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Manufacturer advises to take the syringe out of the refrigerator at least 30 minutes before administration. Patients may self- administer Tegsedi ® after appropriate training in subcutaneous injection technique. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light—consult product literature for further information regarding storage outside refrigerator.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Tegsedi (Akcea Therapeutics UK Ltd) A Inotersen (as Inotersen sodium) 189.33 mg per 1 ml Tegsedi 284mg/1.5ml solution for injection pre-filled syringes | 4 pre-filled disposable injection P £23,700.00
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Manufacturer advises patients should immediately report any signs of unusual or prolonged bleeding, neck stiffness, or atypical severe headache. Self-administration Manufacturer advises patients and carers should be given training in subcutaneous injection technique. Missed doses If a dose is missed, the next dose should be administered as soon as possible, unless the next scheduled dose is within 2 days, in which case the missed dose should not be taken and the next dose should be taken at the normal time.
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284 mg once weekly, for dose adjustments due
First-line fragment. Read the complete Indications and Dose section above.
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