WARNING

During your therapy or for a while after, getting pozelimab-bbfg injection may raise your risk of developing a meningococcal infection, which is an illness that can damage the membrane around the brain and spinal cord and/or spread through the circulation. Infections with meningococci can quickly result in death. In order to lower your risk of contracting this kind of infection, you must have a meningococcal vaccination at least two weeks before to starting pozelimab-bbfg injectable treatment. Before starting therapy, you might need to have a booster dose if you’ve already received this vaccination. Should your physician determine that you must start pozelimab-bbfg injectable treatment immediately, you will be administered the meningococcal vaccine as soon as possible and prescribed an antibiotic for a period of two weeks.

You run the chance of contracting meningococcal disease during or after pozelimab-bbfg injectable treatment, even if you obtain the meningococcal vaccine. Call your doctor right away if you encounter any of the following symptoms, or seek emergency medical attention: headache accompanied by nausea, vomiting, fever, stiff neck, or stiff back; fever; rash and fever; disorientation; aches in your muscles and other flu-like symptoms; or light sensitivity in your eyes.

If you develop a fever or other infection-related symptoms, let your doctor know before starting pozelimab-bbfg injectable treatment. If you currently have a meningococcal infection, your doctor will not provide pozelimab-bbfg injection to you.

A patient safety card detailing the possibility of contracting meningococcal disease during or for a while after your treatment will be provided by your doctor. Keep this card with you at all times while receiving treatment, and for three months following completion of therapy. Present the card to all medical professionals who treat you so they are aware of your risk.

When you start pozelimab-bbfg injectable treatment and every time you refill your prescription, you will get the manufacturer’s patient information sheet (Medication Guide) from your doctor or pharmacist. If you have any questions, make sure to approach your pharmacist or doctor after thoroughly reading the material.

Discuss the potential risks of pozelimab-bbfg injection with your physician.

Why is this medication prescribed?

Pozelimab-bbfg injection is used to treat CD55-deficient protein-losing enteropathy (PLE; CHAPLE disease), a genetic syndrome where the immune system destroys healthy cells in the digestive tract by mistake. The condition affects adults and children aged one year and above. Complement inhibitors are the group of drugs that includes pazelimab-bbfg. It works by blocking the activity of the part of the immune system that may damage cells in the digestive tract.

How should this medicine be used?

Pozelimab-bbfg injection is supplied as a solution, or liquid, that a medical professional can inject subcutaneously, or beneath the skin, or into a vein. Typically, the initial intravenous dose of pozelimab-bbfg injection is infused (given slowly) over a minimum of one hour. Eight days following the initial intravenous dosage, it is then typically administered subcutaneously once a week.

A major allergic reaction could result when administering pozelimab-bbfg injection. For half an hour following your intravenous infusion and your initial subcutaneous injection of the drug, your doctor will closely monitor you. If an allergic reaction occurs, your doctor may decide to reduce or stop your intravenous infusion. Tell your physician right away if you encounter any of the following symptoms: The symptoms may include hives, chest pain, dyspnea, shortness of breath, facial, tongue, or throat swelling, or feeling lightheaded.

Other uses for this medicine

While Pozelimab-bbfg injection is used to treat CD55-deficient protein-losing enteropathy , it may have other off-label uses based on a healthcare provider’s judgment. Off-label use means the medication is prescribed for a condition not officially approved by regulatory authorities. Some healthcare professionals may use chlordiazepoxide off-label for certain conditions, but this should be done cautiously and with careful consideration of potential risks and benefits.

What special precautions should I follow?

Here are some specific precautions to consider:

• If you have any allergies to any of the ingredients in pozelimab-bbfg injectable, other medications, or pozelimab-bbfg itself, let your doctor and pharmacist know. For an ingredient list, ask your pharmacist or consult the Medication Guide.
• Inform the pharmacist and doctor about any additional vitamins, nutritional supplements, herbal items, and prescription and over-the-counter medications you now take or intend to use. It might be necessary for your doctor to adjust your medication dosage or closely watch for any adverse effects.
• Inform your physician of any current or past medical conditions.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Contact your doctor if you become pregnant while taking the pozelimab-bbfg injectable.
• Consult your physician to find out if you require any immunizations before to getting pozelimab-bbfg injectable. Avoid getting immunized without first consulting your physician.

What special dietary instructions should I follow?

• Food Interactions: Some medications may interact with certain foods. Follow any dietary instructions provided by your healthcare provider or pharmacist.
• Alcohol: Check with your healthcare provider about whether there are any restrictions on alcohol consumption while taking Pozelimab-bbfg Injection.

What should I do if I forget a dose?

• Missed Dose: If you forget a dose, contact your healthcare provider or follow the specific guidance provided in the prescribing information.
• Do Not Double Dose: In most cases, do not take a double dose to make up for a missed one. Follow the instructions given by your healthcare provider or in the medication’s information.
• Seek Guidance: If you are unsure about what to do, contact your healthcare provider or pharmacist for advice on how to proceed.

What side effects can this medication cause?

Pozelimab-bbfg injection, like other medications, can cause various side effects. It’s important to note that not everyone will experience these side effects, and their severity can vary from person to person. Common side effects of pozelimab-bbfg injection include:

• Hair loss
• Redness, swelling, and itching at the injection site
• Bleeding gums

Serious side effects are less common but may include:

• Bone fracture

Additional adverse effects are possible with pozelimab-bbfg injection. If you have any odd side effects while taking this medicine, contact your doctor.

It’s important to seek medical attention if any severe or persistent side effects occur. Additionally, abrupt discontinuation of pozelimab-bbfg injection can lead to withdrawal symptoms, so it’s crucial to follow your healthcare provider’s guidance for tapering off the medication if it’s no longer needed. Always discuss any concerns or side effects with your healthcare provider to determine the most appropriate course of action.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage:
  • Store the medication as directed on the packaging or by your healthcare provider.
  • Some medications require refrigeration, while others may be stored at room temperature. Follow the specific storage instructions.
• Disposal:
  • Dispose of unused or expired medication according to local regulations.
  • Do not flush medication down the toilet unless instructed to do so. Instead, use a drug take-back program or follow specific guidelines for disposal provided by your local health department.

In case of emergency/overdose

• Emergency Services: In case of an emergency or suspected overdose, call your local emergency services immediately.
• Poison Control Center: Contact your local poison control center for advice on what to do in case of an overdose. Keep their contact information readily available.
• Symptoms of Overdose: Be aware of the symptoms of overdose that may be listed in the medication information provided by your healthcare provider.

What other information should I know?

• Administration: Administer the medication exactly as prescribed by your healthcare provider. Follow the recommended dosage and schedule.
• Missed Dose: If you miss a dose, contact your healthcare provider for guidance. Do not double up on doses unless instructed to do so.
• Allergies: Inform your healthcare provider about any known allergies or adverse reactions to medications before starting Pozelimab-bbfg Injection.
• Follow-Up Appointments: Attend all follow-up appointments with your healthcare provider to monitor your response to the medication and address any concerns.
• Interactions: Inform your healthcare provider about all medications, supplements, or herbal products you are taking to avoid potential interactions.

Remember, these are general guidelines, and specific details may vary for Pozelimab-bbfg Injection. Always consult with your healthcare provider or pharmacist for the most accurate and up-to-date information tailored to your specific situation.