1. What this product is and what it is used for What Praluent is • Praluent contains the active substance alirocumab. • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Alirocumab binds to PCSK9. How Praluent works Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”). Praluent blocks a protein called PCSK9. • PCSK9 is a protein secreted by liver cells. • “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver. • PCSK9 lowers the number of these receptors in the liver – this causes your “bad” cholesterol to be higher than it should. • By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad” cholesterol – this lowers your “bad” cholesterol levels. What Praluent is used for • Adults with high cholesterol levels in their blood (hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia). • Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk. It is given: - together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, - alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used. Continue to follow your cholesterol-lowering diet while taking this medicine. 2. What you need to know before you use this product Do not use Praluent • if you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Praluent. If you develop a serious allergic reaction, stop using Praluent, talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity, including angioedema (difficulties breathing, or swelling of the face, lips, throat or tongue), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred. For allergic reactions that may occur while taking Praluent, see section 4. Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease. Children and adolescents Do not give this medicine to children and adolescents under 18 years old because there is no experience of using the medicine in these age groups. Other medicines and Praluent Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Praluent is not recommended during pregnancy or breast-feeding. Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines. 3. How to use this product. Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. How much to inject Your doctor will tell you which dose is right for you and how often to inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly)). Your doctor will check your cholesterol levels and may adjust the dose (up or down) during treatment. Always check the label of your pen to make sure you have the right medicine and the right strength. When to inject Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 300 mg dose). To give the 300 mg dose, give two 150 mg injections in a row at two different injection sites. Before you inject Praluent should be allowed to warm to room temperature prior to use. Read the detailed instructions for use leaflet before you inject Praluent. Where to inject Praluent is injected under your skin into the thigh, abdomen or upper arm. Read the detailed instructions for use leaflet on where to inject. Learning how to use the pre-filled pen Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent. • Always read the "Instructions for Use" provided in the box. • Always use the pen as described in the “Instructions for Use”. If you use more Praluent than you should If you use more Praluent than you should, talk to your doctor, pharmacist or nurse. If you forget to use Praluent If you miss a dose of Praluent, inject your missed dose as soon as you can. Then take your next dose at your regular scheduled time. This will keep you on the original schedule. If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse. If you stop using Praluent Do not stop using Praluent without talking with your doctor. If you stop using Praluent, your cholesterol levels can increase. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you develop a serious allergic reaction, stop using Praluent, talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people). Other side effects are: Common (may affect up to 1 in 10 people) • redness, itching, swelling, pain/tenderness where the medicine was injected (local injection site reactions) • upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing • itching (pruritus). Rare (may affect up to 1 in 1,000 people) • red and itchy raised bumps or hives (urticaria) Not Known The following side effects have been reported since the marketing of Praluent, but how often they occur is not known: • flu-like illness • difficulties breathing, or swelling of the face, lips, throat or tongue (angioedema) To report any side effect(s): • Saudi Arabia: - The National Pharmacovigilance and Drug Safety Centre (NPC) o Fax: +966-11-205-7662 o Call NPC at +966-11-2038222, Exts: 2317-2356-2340. o SFDA call center : 19999 o E-mail: [email protected] o Website: www.sfda.gov.sa/npc • Sanofi- Pharmacovigilance: [email protected] 5. How to store this product 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 label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the pen in the outer carton in order to protect from light. If needed, individual pre-filled pens may be kept outside the refrigerator below 25°C for a maximum of 30 days. Protect from light. After removal from the refrigerator, Praluent must be used within 30 days or discarded. Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles. After use put the pen into a puncture-resistant container. Ask your doctor, pharmacist or nurse how to throw away the container. Do not recycle the container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment