Properties
What is it?
SIBRAVA subcutaneous solution 284 mg inclisiran ▼ This medicine is subject to additional monitoring to enable rapid identification of new safety information. You can help by reporting any side effects you experience, including those not listed in this leaflet. The reporting of side effects is described in Section 4. Read the patient information leaflet carefully before you start taking this medicine, as it contains important information for you. Keep the patient information leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine is 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. This applies to any possible side effects, including any that are not listed in this leaflet. The patient information leaflet includes: 1. What SIBRAVA is and what it is used for 2. What you need to know before you take SIBRAVA 3. How to take SIBRAVA 4. Possible side effects 5. How to store SIBRAVA 6. What SIBRAX contains and other information 1. What SIBRAVA is and what it is used for: 1.1. What SIBRAVA is and how it works: SIBRAVA contains the active substance inclisiran, which lowers cholesterol, specifically low-density lipoprotein (LDL) or "bad" cholesterol. High levels of cholesterol (LDL) can lead to problems with your heart or circulation. Inclisiran works by blocking the production of a protein called PCSK9 using RNA interference. This protein can increase cholesterol (LDL) levels, so preventing its production helps to lower cholesterol (LDL) levels. 1.2. What SIBRAVA is used for: SIBRAVA is used to lower cholesterol levels, along with a cholesterol-lowering diet, in adults with high cholesterol levels (including primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia, or mixed dyslipidemia). SIBRAVA is used: - In combination with statins (medicines to treat high cholesterol), sometimes with other cholesterol-lowering medicines, if the maximum dose of statin is not effective enough, or - As monotherapy or in combination with other cholesterol-lowering medicines if statins are not effective or are contraindicated. 2. What you need to know before you take SIBRAVA 2.1. Do not take SIBRAVA: - If you are allergic to inclisiran or any of the other ingredients of this medicine, listed in Section 6. 2.2. Warnings and precautions before taking SIBRAVA Talk to your doctor before taking SIBRAVA: - If you are on dialysis; - If you have severe liver disease; - If you have severe kidney disease. 2.3. Children and adolescents SIBRAVA must not be used in children and adolescents under 18 years of age as there is no experience with the use of the medicine in this age group. 2.4. Other medicines Tell your doctor if you are taking, have recently taken or might take any other medicines. 2.5. Pregnancy and breast-feeding Ask your doctor for advice before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. SIBRAVA should be avoided during pregnancy. It is not known whether SIBRAVA passes into breast milk. Your doctor will decide whether to continue breast-feeding or to take SIBRAVA. Your doctor will weigh the expected benefit of treatment against the benefits and risks of breast-feeding for the baby. 2.6. Driving and using machines SIBRAVA has no effect on the ability to drive or use machines. 2.7. SIBRAVA contains sodium: SIBRAVA 284 mg contains less than 1 mmol (23 mg) of sodium, i.e. it is essentially sodium-free. 3. How to take SIBRAVA The recommended dose of SIBRAVA is 284 mg given as a subcutaneous injection. The next dose is given after 3 months, and subsequent doses every 6 months. Before starting treatment with SIBRAVA, you must follow a cholesterol-lowering diet and may also be taking statins. You should continue the cholesterol-lowering diet and statin therapy during treatment with SIBRAVA. SIBRAVA is given as a subcutaneous injection into the abdomen. It can also be injected into the upper arm or thigh. The medicine is administered by a doctor or healthcare professional. 3.1. If you take more SIBRAVA than you should The injection is given by a doctor or healthcare professional. In the unlikely event that too much medicine is administered, the doctor or healthcare professional will monitor for side effects. 3.2. If you miss a dose of SIBRAVA If you miss your appointment for your SIBRAVA injection, contact your doctor or healthcare professional as soon as possible to arrange your next visit. If you have any questions about taking this medicine, ask your doctor, nurse or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. Common: (in 1 to 10 out of 100 patients) Reactions at the injection site, such as pain, redness or rash. Reporting of side effects If you get any side effects, talk to your doctor. This applies to any possible side effects, including any that are not listed in this leaflet. 5. How to store SIBRAVA Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month. Store below 250C. Do not freeze. Your doctor, pharmacist or nurse will check the medicine and dispose of it if it contains visible particles. Do not dispose of medicines via wastewater or household waste. Your doctor, pharmacist or nurse will dispose of medicines no longer required. These measures will help protect the environment. 6. What SIBRAVA contains and other information 6.1. List of active and other ingredients What SIBRAVA contains Active substance: inclisiran (as sodium salt). 1 ml of inclisiran sodium corresponds to 189 mg of inclisiran. Each pre-filled syringe contains 1.5 ml of solution, which contains 284 mg of inclisiran (equivalent to 300 mg of inclisiran sodium). Other ingredients: water for injections sodium hydroxide (for pH adjustment) phosphoric acid (for pH adjustment) 6.2. What SIBRAVA looks like and contents of the pack SIBRAVA is a solution for injection. It is a clear, colorless to pale yellow solution, practically free from visible particles. 1.5 ml of solution in a 2.25 ml pre-filled syringe with a Type I glass barrel, fitted with a 27G½ needle and a protective cap at one end, and a plunger with a bromobutyl plunger stopper at the other end, the plunger is secured by a lock. 1 syringe is packed in a blister pack. 1 blister pack together with the patient information leaflet is packed in a carton. 6.3. Name and address of the marketing authorisation holder and manufacturer responsible for batch release Marketing authorisation holder: Novartis Overseas Investments AG, Lyssstrasse 35, 4056 Basel, Switzerland Manufacturer: Manufacturer of the finished medicinal product, primary packaging: Corden Pharma S.p.A., Reparto UP3, Via G. Galilei, 17, 20867, Caponago, Italy Secondary packaging: Corden Pharma S.p.A. Viale dell’Industria 3, Caponago, 20867, Italy Quality control: Sandoz GmbH, Biochemiestrasse, 10, 6336, Langkampfen, Austria Conditions of supply: Prescription only