Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Pegvaliase
BioMarin International Limited
A16AB19
pegvaliase
Other alimentary tract and metabolism products
Phenylketonurias
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Revision: 7
Authorised
2019-05-03
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER PALYNZIQ 2.5 MG solution for injection in pre-filled syringe PALYNZIQ 10 MG solution for injection in pre-filled syringe PALYNZIQ 20 MG solution for injection in pre-filled syringe PEGVALIASE ▼ 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 Palynziq is and what it is used for 2. What you need to know before you use Palynziq 3. How to use Palynziq 4. Possible side effects 5. How to store Palynziq 6. Contents of the pack and other information 1. WHAT PALYNZIQ IS AND WHAT IT IS USED FOR Palynziq contains the active substance pegvaliase, an enzyme that can break down a substance called phenylalanine in the body. Palynziq is a treatment for patients aged 16 years and older with phenylketonuria (PKU), a rare inherited disorder that causes phenylalanine from proteins in food to build up in the body. People who have PKU have high levels of phenylalanine and this can lead to serious health problems. _ _ Palynziq reduces the levels of phenylalanine in the blood of patients who have PKU whose blood phenylalanine levels cannot be kept below 600 micromol/l by other means such as by diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PALYNZIQ _ _ DO NOT USE PALYNZIQ - if you have a severe allergy to pegvaliase Read the complete document
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 Palynziq 2.5 mg solution for injection in pre-filled syringe Palynziq 10 mg solution for injection in pre-filled syringe Palynziq 20 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg pre-filled syringe contains 2.5 mg pegvaliase in 0.5 ml solution. Each 10 mg pre-filled syringe contains 10 mg pegvaliase in 0.5 ml solution. Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml solution. The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation. The active substance is a covalent conjugate of the protein phenylalanine ammonia lyase (rAvPAL)* with NHS-methoxypolyethylene glycol (NHS-PEG). * _Anabaena variabilis_ rAvPAL produced by recombinant DNA technology in _Escherichia coli._ The potency of this medicinal product should not be compared to any other PEGylated or non-PEGylated protein of the same therapeutic class. For more information, see section 5.1. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 – 7.4. 2.5 mg pre-filled syringe: Osmolality: 260 – 290 mOsm/kg 10 mg and 20 mg pre-filled syringe: Osmolality: 285 – 315 mOsm/kg, viscous solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. 3 4.2 POSOLOGY AND METHOD OF ADMINISTR Read the complete document