Pegcetacoplan (subcutaneous route)
Available brands
Empaveli
About this medication
Pegcetacoplan injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH. This medicine is available only under a restricted distribution program called Empaveli® REMS (Risk Evaluation and Mitigation Strategy) Program. This product is available in the following dosage forms:
Before using this medication
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of pegcetacoplan injection in the pediatric population. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegcetacoplan injection in the elderly. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
How to use this medication
A nurse or other trained health professional may give you this medicine. It is given as a shot in the stomach, or through an IV catheter placed under your skin, usually in the stomach, thigh, hip or upper arm. It must be given slowly, so the IV will have to stay in place using an infusion pump for at least 30 minutes (for 2 infusion sites) or at least 60 minutes (for 1 infusion site). You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine and the infusion pump. It is very important that you understand the requirements of the Empaveli® REMS program, and become familiar with the Empaveli® medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about: If you use this medicine at home, you will be shown the body areas where the infusion can be given. Use a different body area each time you give yourself an injection. Keep track of where you give each injection to make sure you rotate body areas. This will help prevent skin problems. Do not inject into areas where the skin is tender, red, bruised, or hard or in areas with tattoos, scars, or stretch marks. Allow this medicine to warm to room temperature for 30 minutes before using it. Do not warm it in any other way. Check the liquid in the vial. It should be clear and colorless to slightly yellow solution. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Tell your doctor if you are changing treatment from eculizumab or ravulizumab to Empaveli®. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Call your doctor or pharmacist for instructions. If you miss a dose of this medicine, use it as soon as possible. Do not double doses. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store in the refrigerator. Do not freeze. Keep the medicine in its original carton, away from direct light, until you are ready to use it. Throw away any unused medicine.
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