Pozelimab-bbfg (Intravenous, Subcutaneous)

Pozelimab-bbfg injection is used to treat a condition called CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. This medicine is a monoclonal antibody that affects the immune system.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor checks your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your chance of having serious infections, including a meningococcal infection. Avoid people who are sick or have infections. Tell your doctor right away if you or your child develop headaches, nausea, vomiting, fever, a stiff neck or back, rash, confusion, muscle aches, or if your eyes have become sensitive to light.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There are no appropriate studies on how pozelimab-bbfg injection affects children younger than 1 year of age. Safety and effectiveness have not been established for this age group.

Geriatric

There is no information available on how pozelimab-bbfg injection affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted based on their potential importance and are not necessarily complete.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor might change the dose or frequency for one or both medicines.

• Immune Globulin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food, as interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor about any other medical issues you have, especially:

• Infection (e.g., gonorrhea, influenza, pneumonia)—Use with caution. This medicine may lower your body’s ability to fight infections.

• Meningococcal infection—This medicine should not be given to patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blood in the urine
• body aches or pain
• chills
• confusion
• cough
• drowsiness
• ear congestion
• fever
• headache
• loss of voice
• muscle tremors
• nausea
• pain or swelling in the arms or legs without any injury
• restlessness
• sneezing
• sore throat
• stomach cramps
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Chest tightness
• cloudy urine
• difficulty swallowing
• fast heartbeat
• general feeling of illness
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stiff neck or back

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding gums
• loss or thinning of the hair

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Pharmacologic Class: Pozelimab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you or your child this medicine in a medical facility. The first dose 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 then receive this medicine as a shot under your skin, usually in the stomach, thighs, or upper arms once a week starting on Day 8 after the first dose.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Make sure you have received a vaccine to prevent meningococcus infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines to prevent infections if you are to receive this medicine right away. If you have already received the meningococcal vaccine in the past, your doctor will decide if you need another dose.

Missed Dose

Call your doctor or pharmacist for instructions.