Pozelimab-bbfg (poe-ZEL-i-mab - bbfg)

Treats CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other health provider will give you this medicine.
• This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 1 hour. You will also be given this medicine as a shot under your skin, usually in the stomach, thighs, or upper arms.
• You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicines to prevent infections if you are to receive this medicine right away.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pozelimab-bbfg works. Tell your doctor if you are also receiving an immunoglobulin injection.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a fever or any kind of infection.
• This medicine can increase your risk for serious infections, including meningococcal infection. Avoid people who are sick or have infections.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone fracture
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, confusion, nausea, vomiting, stiff neck or back, eyes sensitive to light

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed or the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088