Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Volanesorsen sodium
Akcea Therapeutics Ireland Limited
C10AX18
volanesorsen
Other lipid modifying agents
Hyperlipoproteinemia Type I
Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.,
Revision: 6
Authorised
2019-05-03
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER WAYLIVRA 285 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE volanesorsen ▼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 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 Waylivra is and what it is used for 2. What you need to know before you use Waylivra 3. How to use Waylivra 4. Possible side effects 5. How to store Waylivra 6. Contents of the pack and other information 1. WHAT WAYLIVRA IS AND WHAT IT IS USED FOR Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS). FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood. This can lead to inflammation of your pancreas, causing severe pain. Together with a controlled low-fat diet, Waylivra helps to lower the levels of triglycerides in your blood. Waylivra may be given after you have already received other medicines used to lower the levels of triglycerides in blood without them having much effect. You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high.. You should continue the very low-fat diet that your doctor has prescribed during treatment with Waylivra. This medicine is inten Aqra d-dokument sħiħ
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 Waylivra 285 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen. Each single-dose pre-filled syringe contains 285 mg of volanesorsen in 1.5 ml solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363- 485 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS. Prior to initiating Waylivra, secondary causes of hypertriglyceridemia (e.g. uncontrolled diabetes, hypothyroidism) should be excluded or appropriately addressed. The recommended starting dose is 285 mg in 1.5 ml injected subcutaneously once weekly for 3 months. Following 3 months, dose frequency should be reduced to 285 mg every 2 weeks. However, treatment should be discontinued in patients with a reduction in serum triglycerides <25% or who fail to achieve serum triglycerides below 22.6 mmol/L after 3 months on volanesorsen 285 mg weekly. After 6 months of treatment with volanesorsen, increase of dose frequency to 285 mg weekly should be considered if response has been inadequate in terms of serum triglyceride reduction as evalua Aqra d-dokument sħiħ