With our 150-year legacy of helping patients, Pfizer is committed to providing immunoglobulin (Ig) treatment options to patients who rely on them.
Important Safety Information
Indications and Usage
PANZYGA (Immune Globulin Intravenous [Human] – ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older, chronic immune thrombocytopenia (cITP) in adults and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
PANZYGA is a liquid medicine for infusion that contains immunoglobulin G (IgG), which are proteins that help fight infection. It is made from human plasma that is donated by healthy people and contains antibodies. For patients with PI, PANZYGA helps replace the missing antibodies in the body. For patients with cITP, PANZYGA helps the body produce more platelets (the blood cells that help blood clot) to control or prevent bleeding. For patients with CIDP, PANZYGA may help improve mobility and hand strength.
PANZYGA is given into a vein (intravenously) in a hospital, infusion center, doctor’s office, or at home by a trained healthcare provider (HCP).
Selected Safety Information
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
See Full Prescribing Information, including complete BOXED WARNING, below.
Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer PANZYGA at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Do not use PANZYGA if you:
Have had a severe allergic reaction to immune globulin or other blood products
Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency, with antibodies against IgA and a history of hypersensitivity
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
PANZYGA can cause serious side effects. If any of the following problems occur after starting PANZYGA, stop the infusion immediately and contact your HCP or call emergency services:
Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction
Bad headache with nausea, vomiting, stiff neck, fever, drowsiness, painful eye movements, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain
Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem (decreased kidney function or kidney failure)
Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot, which could happen in the heart, brain, lungs, or elsewhere in the body
Brown or red urine, swelling, fatigue, fast heart rate, difficulty breathing, or yellow skin or eyes. These could be signs of a liver or blood problem
Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem
Fever over 100°F. This could be a sign of an infection
Headache, fatigue or confusion, vision problem, chest pain, difficulty breathing, irregular heartbeat, or pounding in your chest, neck, or ears. These could be signs of high blood pressure
Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine.
What are the possible or reasonably likely side effects for PANZYGA?
The most common side effects that may occur with PANZYGA are:
Increased blood pressure
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.
Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.
Pfizer is proud to support the lg community with a commitment to helping meet the diverse treatment needs of patients.
PANZYGA is an FDA-approved IVIg therapy to treat adults with CIDP or cITP, and people 2 years of age and older with PI.
For adults with CIDP, PANZYGA may help improve arm and leg strength and mobility and general activity level
For people 2 years of age and older with PI, PANZYGA helps replace antibodies that are missing from the immune system, which may help reduce the risk of infection
For adults with cITP, PANZYGA helps boost platelet count, which may help control and prevent bleeding
PANZYGA is a liquid medicine given by infusion that contains purified antibodies known as immunoglobulin G (IgG).
PANZYGA offers resources to help support patients on their IVIg therapy journey.
Pfizer IGuideTM can help you understand your insurance coverage and out-of-pocket costs for your prescribed PANZYGA, as well as identify financial assistance options for which you may be eligible.
If you have been prescribed PANZYGA and have questions about your coverage, call Pfizer IGuideTM Monday through Friday, 8 AM to 8 PM ET, at 1-844-448-4337.
Pfizer IGuideTM can help identify financial assistance resources for which you may be eligible to help with out-of-pocket costs for PANZYGA
Commercially Insured Patients
If you have commercial, employer, or private coverage, including coverage purchased through a state health insurance marketplace, you may be eligible for the PANZYGA Co-Pay Program, which can help cover the cost of your co-pay. Eligible patients may pay as little as $0 per PANZYGA treatment. The value of the co-pay card is limited to a maximum of $5000* per calendar year
If you have government-funded insurance and need help to cover the cost of PANZYGA, Pfizer IGuideTM can help identify financial support options including alternate coverage resources, if available
If you do not have health insurance and cannot afford PANZYGA treatment, Pfizer IGuideTM can connect you to potential resources that may help cover the cost of PANZYGA, including how to apply to Medicaid if you may be eligible
*Terms and conditions/eligibility requirements apply. See full terms and conditions here. Patients must be 2 years or older and have commercial insurance to be eligible. Patients are not eligible if they are enrolled in a state or federally funded insurance program.
PANZYGA CIDP Patient Brochure
Learn more about CIDP, PANZYGA treatment, and the support available to you.
The GBS|CIDP Foundation is committed to sharing the most accurate information from the world’s leading experts, many from our Global Medical Advisory Board. The COVID-19 situation changes daily and we will continue to share updates that are vetted by the experts in GBS. In addition, we are in regular contact with the FDA representing the patient voice in the top-level decision-making. We understand that there are many opinions creating confusion so please consider the source of your information before drawing conclusions. As always, all decisions should be made with your personal physician based on your own health. Please continue to check our website for updated information.
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