Pegcetacoplan

Generic name: Pegcetacoplan
Brand names: Empaveli
Dosage form: subcutaneous solution (1080 mg/20 mL)
Drug class: Selective immunosuppressants

Usage of 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.

Pegcetacoplan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the infusion. Tell your caregiver if you feel light-headed or if you have chest pain, trouble breathing, or swelling in your face.

Call your doctor right away if you have signs of infection such as:

muscle pain with flu-like symptoms (fever, chills);

fever and a rash or headache;

headache with nausea and vomiting or stiffness in your neck or back;

clammy skin;

extreme pain;

fast heartbeats, shortness of breath;

confusion; or

your eyes may be more sensitive to light.

If you stop using pegcetacoplan, tell your doctor if you have any new or worsening symptoms, such as: tiredness, confusion, stomach pain, trouble breathing or swallowing, blood in your urine, (in men) trouble having an erection, chest pain, pain in one leg, or numbness or weakness on one side of the body.

Common side effects of pegcetacoplan may include:

stomach pain, vomiting, diarrhea;

cold sores;

cold symptoms such as stuffy nose, sneezing, sore throat, cough;

tiredness; or

pain, itching, warmth, redness, bruising, bleeding, swelling, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Pegcetacoplan

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.

Relate drugs

How to use Pegcetacoplan

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria:

SuBCutaneous: 1,080 mg twice weekly infused via a commercially available infusion pump with a reservoir of at least 20 mLTo reduce the risk of hemolysis with abrupt treatment discontinuation when switching from C5 inhibitors:-For patients switching from eculizumab, initiate this drug while continuing eculizumab at its current dose. After 4 weeks, discontinue eculizumab before continuing on monotherapy with this drug-For patients switching from ravulizumab, initiate this drug no more than 4 weeks after the last dose of ravulizumabComments:-Vaccinate against encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B at least 2 weeks prior to initiating therapy according to current ACIP guidelines.-It is recommended to provide 2 weeks of antibacterial drug prophylaxis if this drug must be initiated immediately and vaccines are administered less than 2 weeks before starting therapy.Use: For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

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.

What other drugs will affect Pegcetacoplan

Other drugs may affect pegcetacoplan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.