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What is PANZYGA?

PANZYGA is a liquid medicine for infusion that contains immunoglobulin G (IgG). It is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI or cITP. In patients with CIDP, these antibodies block the body from attacking its own nerve cells.

What should I know before taking PANZYGA?

• PANZYGA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) work less effectively for you. Before you get any vaccines, tell your healthcare provider that you take PANZYGA
• Decreased kidney function and kidney function failure can occur
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting can occur
• Elevated blood pressure can occur particularly in patients who have a history of hypertension (high blood pressure)
• If you are elderly, with heart or kidney problems, discuss with your healthcare provider prior to initiating treatment with PANZYGA
• PANZYGA is made from human blood and therefore may have a risk of transmitting infectious agents, including viruses and, theoretically, the variant Creutzfeldt-Jakob disease (CJD) and CJD agent. The production and manufacturing process reduces this risk, but the risk cannot be eliminated

How are PANZYGA treatments given?

PANZYGA is in a class of medicine called intravenous immunoglobulin (IVIg) therapy. PANZYGA is given as an infusion through a small needle in a vein administered by a healthcare provider. Your infusion will start at a slow rate. It may gradually increase if you tolerate it well. That is why your healthcare provider will monitor you during your infusion. They will be looking for signs of infusion reactions. These reactions can include headache, abdominal pain, fever, nausea, fatigue, vomiting, dizziness, and anemia. They may stop your PANZYGA treatment if you experience a severe reaction. Slowing or stopping the infusion may help these symptoms to go away.

What were the results of the clinical studies of PANZYGA?

In a clinical study of adult patients with CIDP who received PANZYGA:

• In the group of 69 patients treated with 1 g/kg of PANZYGA, 80% of patients improved
• PANZYGA was also tested at a higher dose of 2 g/kg in 36 patients. 92% of patients who received the 2 g/kg dose of PANZYGA improved

In a clinical study of patients aged 2 years or older with PI who received PANZYGA:

• In a clinical study, PANZYGA helped prevent serious bacterial infections (SBIs) in people with PI. In a group of 51 patients treated with PANZYGA at a dose between 200 and 800 mg per kg body weight every 3 or 4 weeks, a total of 50 patient-years were studied and 4 SBIs were observed

In a clinical study of adult patients with cITP who received PANZYGA:

• In a clinical study, PANZYGA helped increase platelets (a type of blood cell) and decrease bleeding in patients with cITP. In a group of 36 patients treated with PANZYGA at a dose of 2 g/kg body weight administered as 2 daily 1 g/kg doses given on 2 consecutive days, approximately 81% (29 of 36) patients responded to PANZYGA with an increase in platelet count within 7 days of treatment

What are the most common side effects seen with PANZYGA?

• For adults with CIDP, the most common adverse reactions during a clinical trial were: headache, fever, skin irritation, and blood pressure increase
• For people 2 years of age and older with PI, the most common adverse reactions during a clinical trial were: headache, abdominal pain, fever, nausea, sinusitis, fatigue, and bronchitis
• For adults with cITP, the most common adverse reactions during a clinical trial were: headache, fever, nausea, vomiting, dizziness, and anemia

How can I keep track of my PANZYGA treatments?

It is important to keep an infusion journal to record details of each PANZYGA infusion, so that your healthcare provider can monitor your progress. Be sure to fill out every section and keep an accurate record of each time your PANZYGA is administered. Please remember to bring your tracker to any appointments with your healthcare provider. During your first few infusions, it is recommended that you ask your infusion nurse or trainer to help you complete your tracker.

Download the PANZYGA Therapy Tracker to keep track of when you receive PANZYGA.

To download the Full Prescribing Information including complete BOXED WARNING in English, click here.

To download the Full Prescribing Information  including complete BOXED WARNING in Spanish, click here.

How long does it take to infuse PANZYGA?

For adult patients with CIDP who receive PANZYGA:

• Your first PANZYGA infusion will take the most time
• Your other PANZYGA infusions may last several hours

For patients aged 2 years or older with PI who receive PANZYGA:

• Your first PANZYGA infusion will take the most time
• Your other PANZYGA infusions may last between 1¼ and 2 hours

For adult patients with cITP who receive PANZYGA:

• Your first PANZYGA infusion will take the most time
• Your other PANZYGA infusions may last about 3 hours