Pozelimab-bbfg Injection

Receiving pozelimab-bbfg 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/or may spread through the bloodstream) during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a meningococcal vaccine at least 2 weeks before you begin your treatment with pozelimab-bbfg injection to decrease the risk that you will develop this type of infection. If you have received this vaccine 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 pozelimab-bbfg injection right away, you will receive your meningococcal vaccine as soon as possible and take an antibiotic for 2 weeks.

Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with pozelimab-bbfg 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; 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 pozelimab-bbfg injection. Your doctor will not give you pozelimab-bbfg injection if you already have a meningococcal infection.

Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 3 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pozelimab-bbfg injection and each time you refill your prescription. 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(s) of receiving pozelimab-bbfg injection.

Pozelimab-bbfg injection is used in adults and children 1 year of age and older to treat CD55-deficient protein-losing enteropathy (PLE; CHAPLE disease; an inherited condition in which the immune system mistakenly attacks and destroys healthy cells in the digestive tract). Pozelimab-bbfg is in a class of medications called complement inhibitors. It works by blocking the activity of the part of the immune system that may damage cells in the digestive tract.

Pozelimab-bbfg injection comes as a solution (liquid) to be injected intravenously (into a vein) and subcutaneously (under the skin) by a healthcare provider. The first dose of pozelimab-bbfg injection is usually infused (injected slowly) intravenously over a period of at least 1 hour. Thereafter, it is usually given subcutaneously once a week, starting 8 days after the first intravenous dose.

Pozelimab-bbfg injection may cause serious allergic reactions. Your doctor will watch you carefully for 30 minutes after you receive your intravenous infusion and after your first subcutaneous injection of the medication. Your doctor may slow or stop your intravenous infusion if you have an allergic reaction. If you experience any of the following symptoms, tell your doctor immediately: hives; chest pain; difficulty breathing; shortness of breath; swelling of your face, tongue, or throat; or feeling faint.

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

Before receiving pozelimab-bbfg injection,

• tell your doctor and pharmacist if you are allergic to pozelimab-bbfg, any other medications, or any of the ingredients in pozelimab-bbfg injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other 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 any other medical condition(s).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving pozelimab-bbfg injection, call your doctor.
• check with your doctor to see if you need to receive any vaccinations before receiving pozelimab-bbfg injection. Do not have any vaccinations without talking to your doctor.

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

If you miss an appointment to receive a dose of pozelimab-bbfg injection, call your doctor right away.

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

• hair loss
• redness, swelling, and itching at the injection site
• bleeding gums

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

• bone fracture

Pozelimab-bbfg injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

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.

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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