Pozelimab

Pozelimab is for adults and children who are at least 1 year old to treat complement hyperactivation, angiopathic thrombosis, and protein losing enteropathy (CHAPLE) syndrome.

Pozelimab may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Pozelimab is given as an injection into a vein and also under the skin by a healthcare provider.

You will be monitored for a short time to ensure you do not have an allergic reaction.

You may need medical tests.

You may get infections more easily, including serious or life-threatening infections. Contact your doctor if you have flu symptoms, cough, night sweats, headache, neck stiffness, increased sensitivity to light, confusion, or vision problems.

Ensure you are up to date on all vaccines before you begin using pozelimab. Discuss with your doctor if you are not up to date on your vaccines.

You should not use pozelimab if you have a meningococcal infection.

Tell your doctor if you have:

• an infection or fever.

Make sure you are up to date on all vaccines before you start using pozelimab. Talk to your doctor if you are not up to date on your vaccines.

Tell your doctor if you are pregnant or breastfeeding.

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

Read the Patient Wallet Card about the symptoms of meningococcal or other infections and learn what symptoms to watch for. Keep the card with you at all times.

You may get infections more easily, including serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• headache, neck stiffness, increased sensitivity to light;
• nausea, vomiting;
• confusion, drowsiness;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Common side effects of pozelimab may include:

• hair loss;
• bone fracture;
• itchy, raised red patches of skin; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Usual Adult Dose for CHAPLE Syndrome:

Initial dose: Day 1: 30 mg/kg by intravenous infusion over a minimum of 1 hourMaintenance dose: Day 8 and thereafter: 10 mg/kg subcutaneously once a weekMaximum dose: 800 mg once a weekComments:-According to Advisory Committee on Immunization Practices (ACIP) guidelines, meningococcal vaccination should be completed at least 2 weeks before administering the first dose of this drug.-The maintenance dosage may be increased to 12 mg/kg once a week if there is insufficient clinical response after at least three weekly doses.-Doses greater than 400 mg require two injections.-Do not exceed the maximum infusion rate of 1000 mg/hour.-Monitor for 30 minutes after completing the infusion.-This drug has not been studied in the geriatric population.Use: For the treatment of adult patients with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

Usual Pediatric Dose for CHAPLE Syndrome:

1 year or older:Initial dose: Day 1: 30 mg/kg by intravenous infusion over a minimum of 1 hourMaintenance dose: Day 8 and thereafter: 10 mg/kg subcutaneously once a weekMaximum dose: 800 mg once a weekComments:-According to ACIP guidelines, meningococcal vaccination should be completed at least 2 weeks before administering the first dose of this drug.-The maintenance dosage may be increased to 12 mg/kg once a week if there is insufficient clinical response after at least three weekly doses.-Doses greater than 400 mg require two injections.-Do not exceed the maximum infusion rate of 1000 mg/hour.-Monitor for 30 minutes after completing the infusion.Use: For the treatment of pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

Call your doctor for instructions if you miss an appointment for your Pozelimab injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Tell your doctor about all your other medicines, especially:

• intravenous immunoglobulin.

This list is not complete. Other drugs may affect pozelimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.