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. These infections may cause death in a short period of time. You will need to receive certain vaccines 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 these vaccines 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 vaccines for certain bacterial infections, there is still a risk that you may develop serious infections 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; rapid heartbeat; shortness of breath; clammy skin; 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 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 necessary 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.

Talk to your doctor about the risk of receiving pegcetacoplan injection.

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.

Pegcetacoplan injection comes as a solution (liquid) in a vial to be injected subcutaneously (just under the skin) via an infusion pump or an on-body injector twice weekly. Pegcetacoplan injection may be given to you by a nurse or other healthcare provider in a medical facility, or you may be told to inject the medication at home. It is usually injected twice a week. If pegcetacoplan injection is used with an infusion pump, it is usually given over 30 minutes (if using 2 infusion sites) or about 60 minutes (if using 1 infusion site). If it is used with an on-body injector, it is usually given over 30 to 60 minutes. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pegcetacoplan injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

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, and inject the medication, and dispose of the medication and supplies. Carefully read the manufacturer's instructions for use that comes with the medication. 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.

Be sure that the skin in the area where you plan to use pegcetacoplan injection is clean, dry, and healthy. 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.

You can inject pegcetacoplan injection using an infusion pump anywhere on the front of your thighs (upper leg), hips, or abdomen (stomach), and the back of the upper arm. If you are using more than 1 infusion site, give each infusion at least 3 inches (7.5 centimeters) away from other infusion sites.

You can apply the on-body injector anywhere on the abdomen (stomach) except your navel and the area 1 inch (2.5 centimeters) around it. Choose a different spot each time you apply the on-body injector. Do not apply the on-body injector in an area directly under a belt or waistband.

Dispose of used needles, syringes, tubing, and on-body delivery systems in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Pegcetacoplan injection controls PNH but does not cure it. Continue to use pegcetacoplan injection even if you feel well. Do not stop using pegcetacoplan injection without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving pegcetacoplan injection,

• tell your doctor and pharmacist if you are allergic to pegcetacoplan injection, any other medications, or any of the ingredients in pegcetacoplan injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney problems or any other medical condition(s).
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 40 days after your final dose. Pegcetacoplan may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving pegcetacoplan and for 40 days after the final dose.
• you should know that your condition may cause too many red blood cells to break down after you stop receiving pegcetacoplan injection. This could result in blood clots. Your doctor will monitor you carefully and may order laboratory tests for at least 8 weeks after you finish your treatment. Call your doctor right away if you develop any of the following symptoms: extreme tiredness, blood in urine, stomach pain, difficulty swallowing, shortness of breath, or an inability to get or keep an erection.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it and continue your regular dosing schedule.

Pegcetacoplan injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• joint, muscle, arm, leg, or back pain
• headache
• redness, pain, itching, or swelling at the injection site
• cough
• mouth and throat pain
• dizziness
• bruising

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING, HOW, or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment.

Pegcetacoplan injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store pegcetacoplan injection in the refrigerator.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pegcetacoplan injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving pegcetacoplan injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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