Pegcetacoplan
Generic name: pegcetacoplan [ peg-SET-a-KOE-plan ]
Brand name: Empaveli
Dosage form: subcutaneous solution (1080 mg/20 mL)
Drug class:Selective immunosuppressants
What is pegcetacoplan?
Pegcetacoplan is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults.
Pegcetacoplan is available only under a special program. You must be registered in the program and understand the risks and benefits of pegcetacoplan.
Pegcetacoplan may also be used for purposes not listed in this medication guide.
Warnings
You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or your eyes are more sensitive to light.
You will need to receive certain vaccinations before you start using pegcetacoplan.
Read the Patient Safety Card about serious infections and the symptoms to watch for. Keep the card with you at all times while using pegcetacoplan and for at least 2 months after your last dose. Your infection risk could last for several weeks after you stop using pegcetacoplan.
Before taking this medicine
You should not be treated with pegcetacoplan if you are allergic to it, if you have a serious infection (such as pneumonia, meningitis or influenza type B), or if you are not currently vaccinated against these diseases (unless the risks of delaying treatment outweigh the risks of developing an infection).
At least 2 weeks before you start using pegcetacoplan, you will need to receive vaccines to protect against meningococcal infections, pneumonia, and influenza type B (Hib). Even if you've received these vaccinations in the past, you may need them again.
If you need to start receiving pegcetacoplan before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of pegcetacoplan treatment.
Tell your doctor if you have recently had any symptoms of infection (fever, chills, or flu-like symptoms).
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using pegcetacoplan and for at least 40 days after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 40 days after your last dose.
Not approved for use by anyone younger than 18 years old.
