Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
vutrisiran sodium
Alnylam Netherlands B.V.
N07XX18
vutrisiran
Other nervous system drugs
Amyloid Neuropathies, Familial
Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Revision: 1
Authorised
2022-09-15
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMVUTTRA 25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE vutrisiran This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. • 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 Amvuttra is and what it is used for 2. What you need to know before you are given Amvuttra 3. How Amvuttra is given 4. Possible side effects 5. How to store Amvuttra 6. Contents of the pack and other information 1. WHAT AMVUTTRA IS AND WHAT IT IS USED FOR The active substance in Amvuttra is vutrisiran. WHAT AMVUTTRA IS USED FOR Amvuttra is used for the treatment of an illness called ‘hereditary ATTR’ or ‘hATTR amyloidosis’. This is an illness which runs in families. hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin’ (TTR). This protein is made mostly in the liver and carries vitamin A and other substances around the body. In people with this illness, small fibres of TTR protein clump together to make deposits called ‘amyloid’. Amyloid can build up around or within the nerves, heart, and other places in the body, stopping them from working normally. This causes the symptoms of the illness. HOW AMVUTTRA WORKS Amvuttra works by lowering the amount of TTR protein made by the liver which means there is less TTR protein in the blood that can form amyloid. This can help to reduce the effects of this illness. Amvuttra is used in adults only. 2. WHAT YOU NEED TO KNOW BEF Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Amvuttra 25 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg vutrisiran in 0.5 mL solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless-to-yellow solution (pH of approximately 7; osmolality 210 to 390 mOsm/kg). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amvuttra is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. Treatment should be started as early as possible in the disease course to prevent the accumulation of disability. Posology The recommended dose of Amvuttra is 25 mg administered via subcutaneous injection once every 3 months. Vitamin A supplementation at approximately, but not exceeding, 2 500 IU to 3 000 IU vitamin A per day is advised for patients treated with Amvuttra (see section 4.4). The decision to continue treatment in those patients whose disease progresses to stage 3 polyneuropathy should be taken at the discretion of the physician based on the overall benefit and risk assessment. _Missed dose _ If a dose is missed, Amvuttra should be administered as soon as possible. Dosing should be resumed every 3 months, from the most recently administered dose. Special populations _ _ _ _ _Elderly patients _ No dose adjustment is required in patients ≥ 65 years of age (see section 5.2). 3 _Hepatic impairment _ No dose Prečítajte si celý dokument