Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
inotersen sodium
Akcea Therapeutics Ireland Limited
N07
inotersen
Other nervous system drugs
Amyloidosis
Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Revision: 14
Authorised
2018-07-06
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER TEGSEDI 284 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE inotersen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tegsedi is and what it is used for 2. What you need to know before you use Tegsedi 3. How to use Tegsedi 4. Possible side effects 5. How to store Tegsedi 6. Contents of the pack and other information 1. WHAT TEGSEDI IS AND WHAT IT IS USED FOR Tegsedi contains the active substance inotersen. Inotersen is used to treat adults with hereditary transthyretin amyloidosis. Hereditary transthyretin amyloidosis is a genetic disease, which causes build-up of small fibres of a protein called transthyretin in the organs of your body stopping them from working properly. Tegsedi is used when the disease is causing symptoms of polyneuropathy (nerve damage). Inotersen, is a type of medicine called an antisense oligonucleotide inhibitor. It works by reducing production of transthyretin by the liver and so lowers the risk of fibres of transthyretin being deposited in body organs and causing symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEGSEDI _ _ DO NOT USE TEGSEDI IF: - You are allergic to inotersen or any of the other ingredients of this medicine (listed in section 6). - Tests show you have excessively low numbers of platelets, the cells in your blood which stick together helping it clot. - Tests of kidney function or protein in the urine show signs of severe kidney problems. - You have severe reduction in liver Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tegsedi 284 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 189 mg inotersen (as inotersen sodium). Each pre-filled syringe contains 284 mg inotersen (as inotersen sodium) in 1.5 mL of solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to pale yellow solution (pH 7.5 – 8.8). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 10 9 /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 p Aqra d-dokument sħiħ