Pegcetacoplan

Pregnancy Pregnancy: Pegcetacoplan is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive methods. Breast-feeding Breast-feeding: Discontinuation of breast-feeding is recommended during treatment with pegcetacoplan. Driving Driving: Pegcetacoplan has no or negligible influence on the ability to drive and use machines. Talk to your doctor, pharmacist, or nurse before using Pegcetacoplan. Before starting Pegcetacoplan, tell your doctor if you have any infection. As the medicine targets the complement system, which is part of the body's defences against infection, the use of this medicine increases the risk of infections, including those caused by so-called encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ These are serious infections affecting the nose, throat, and lungs or the linings of the brain and can spread throughout the blood and body. Talk to your doctor before starting Pegcetacoplan to make sure you receive vaccination against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae if you have not had these vaccines in the past. If you have had these vaccines in the past, you may still need additional vaccines before starting this medicine. These vaccines should be given at least 2 weeks before starting therapy. If you cannot be vaccinated 2 weeks before, your doctor will prescribe antibiotics to reduce the risk of infection for 2 weeks after vaccination. After vaccination, you may be monitored more closely by your doctor for symptoms of infection. Symptoms of infection: If you experience any of the following symptoms, you should inform your doctor immediately: - headache and fever - fever and rash - fever with or without chills or rigors - shortness of breath - rapid heart rate - clammy skin - headache with stiff neck or stiff back - headache with nausea (feeling sick) or vomiting - eyes sensitive to light - muscle aches with flu-like symptoms - confusion - extreme pain or discomfort Make sure you keep your vaccinations up to date. You should also be aware that vaccines reduce the risk of serious infections but do not prevent all serious infections. In accordance with national recommendations, your doctor may consider that you need supplementary measures, such as antibacterial medicines, to prevent infection. Allergic reactions may occur in some patients. In the event of a severe allergic reaction, discontinue the Pegcetacoplan infusion and seek medical help immediately. A severe allergic reaction may present as difficulty breathing, chest pain or tightness in the chest, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing, or collapse. Injection site reactions have been observed with the use of Pegcetacoplan. You should undergo adequate training in proper injection technique before self-administration. During your treatment with Pegcetacoplan, your doctor will perform regular tests, including blood tests for lactate dehydrogenase (LDH) levels and renal function tests, and may adjust your dose if necessary. The use of silica reagents in coagulation tests should be avoided, as it may result in artificial prolongation of activated partial thromboplastin time (aPTT). Do not give this medicine to children under 18 years of age, as there are no data available on its safety and efficacy in this age group. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.