Pegcetacoplan Injection
Receiving pegcetacoplan injection may increase the risk that you will develop a meningococcal infection (an infection that may affect the covering of the brain and spinal cord and may spread through the bloodstream) or other serious infections during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a certain vaccine at least 2 weeks before you begin your treatment with pegcetacoplan injection to decrease the risk that you will develop this type of infection. If you have received this vaccine in the past, you may need to receive a booster dose before you begin your treatment. If your doctor feels that you need to begin treatment with pegcetacoplan injection right away, you will receive your vaccines as soon as possible but will need to take an antibiotic for 2 weeks.
Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with pegcetacoplan injection. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; rash and fever; confusion; muscle aches and other flu-like symptoms; or if your eyes are sensitive to light.
Tell your doctor if you have fever or other signs of infection before you begin your treatment with pegcetacoplan injection. Your doctor may not give you pegcetacoplan injection if you already have a certain type of infection.
Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease or a serious infection during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 2 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk.
A program called Empaveli REMS has been set up to decrease the risks of receiving pegcetacoplan injection. You can only receive pegcetacoplan injection from a doctor who has enrolled in this program, has talked to you about the risks of meningococcal disease and other serious infections, has given you a patient safety card, and has made sure that you received neccessary vaccinations.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with pegcetacoplan injection and each time you receive an injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
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Talk to your doctor about the risk of receiving pegcetacoplan injection.
🔔 Why is this medication prescribed?
Pegcetacoplan injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body). Pegcetacoplan is in a class of medications called monoclonal antibodies. It works by blocking the activity of the part of the immune system that may damage blood cells.
🔔 How should this medicine be used?
Pegcetacoplan injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) via a pump by a healthcare provider in a medical facility or you may be given the medication to use at home. It is usually given over 30 minutes (if using 2 infusion sites) or about 60 minutes (if using 1 infusion site) twice weekly.
Pegcetacoplan injection may cause serious or life-threatening reactions during and after the infusion of the medication. Stop your infusion and tell your doctor or get emergency medical treatment if you experience any of the following symptoms during or after the infusion: difficulty breathing, shortness of breath and wheezing, chest pain, swelling of your face, tongue, or throat, feeling faint, dizziness, nausea, vomiting, confusion, anxiety, facial swelling, hives, or itching. Your doctor may need to stop your treatment if you experience any of these side effects.
If you will be using pegcetacoplan injection at home, your healthcare provider will show you or your caregiver how to store, inject, dispose of the medication and supplies. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using pegcetacoplan injection.
Remove the medication from the refrigerator 30 minutes before your are ready to inject the medication. Place it on a flat surface and allow it to reach room temperature. Do not try to warm the medication.
You can inject pegcetacoplan injection anywhere on the front of your thighs (upper leg), hips, or abdomen (stomach), and the back of the upper arm. Give each infusion at least 3 inches (7.5 centimeters) away from other infusion sites. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, or where there are tattoos, scars or stretch marks.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
