Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Givosiran
Alnylam Netherlands B.V.
A16AX16
givosiran
Various alimentary tract and metabolism products
Porphyrias, Hepatic
Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
Revision: 5
Authorised
2020-03-02
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER GIVLAARI 189 MG/ML SOLUTION FOR INJECTION givosiran 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 or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Givlaari is and what it is used for 2. What you need to know before you are given Givlaari 3. How Givlaari is given 4. Possible side effects 5. How to store Givlaari 6. Contents of the pack and other information 1. WHAT GIVLAARI IS AND WHAT IT IS USED FOR WHAT GIVLAARI IS Givlaari contains the active substance ‘givosiran’. WHAT GIVLAARI IS USED FOR Givlaari is used to treat acute hepatic porphyria in adults and adolescents aged 12 years and older. WHAT ACUTE HEPATIC PORPHYRIA IS Acute hepatic porphyria is a rare illness that runs in families. It is caused by a defect in one of the proteins that make a molecule called haem in the liver. Because there is a problem in one of the proteins required to make haem, there is a build-up of some of the substances that are used to produce haem, namely aminolevulinic acid (ALA) and porphobilinogen (PBG). Having too much ALA and PBG can injure nerves and cause serious attacks of pain, nausea, muscle weakness and changes in mental functioning. Some people with acute hepatic porphyria may also have symptoms, such as pain and nausea, in between attacks. Longer-term complications that can be seen in people with acute hepatic porphyria include high blood pressure, chronic kidney disease and liver disease. HOW GIVLAARI WORKS Thi Прочетете целия документ
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 Givlaari 189 mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains givosiran sodium equivalent to 189 mg givosiran. Each vial contains 189 mg givosiran. Excipients with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to yellow solution (pH of approximately 7.0; osmolality: 275 – 295 mOsm/kg). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated under the supervision of a healthcare professional experienced in the management of porphyria. Posology The recommended dose of Givlaari is 2.5 mg/kg once monthly, administered via subcutaneous injection. Dosing is based on actual body weight. The patient dose (in mg) and volume (in mL) should be calculated as follows: Patient body weight (kg) × dose (2.5 mg/kg) = total amount (mg) of medicinal product to be administered. Total amount (mg) divided by vial concentration (189 mg/mL) = total volume of medicinal product (mL) to be injected. _Missed dose _ If a dose is missed, treatment should be administered as soon as possible. Dosing should be resumed at monthly intervals following administration of the missed dose. 3 _Dose modification for adverse reactions _ In patients with clinically relevant transaminase elevations, who have dose interruption and subsequent improvement in transaminase levels, a dose resumption at 1.25 mg/kg once monthly could be considered (see sections 4.4 and 4.8). Special populations _Elderly _ No dose Прочетете целия документ