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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 maintain 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).

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
See full prescribing information for complete BOXED WARNING

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:

Headache
Nausea
Fever
Increased blood pressure
Dermatitis
Fatigue
Abdominal pain
Dizziness
Anemia

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.

Expand

INDICATIONS AND USAGE

PANZYGA is given into a vein (intravenously) in a hospital, infusion center, doctor’s office, or at home by a trained healthcare provider (HCP).

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
See full prescribing information for complete BOXED WARNING

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:

Headache
Nausea
Fever
Increased blood pressure
Dermatitis
Fatigue
Abdominal pain
Dizziness
Anemia

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.

PANZYGA^® is a registered trademark of Octapharma AG.

Please click here for Full Prescribing Information, including complete BOXED WARNING.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

Pfizer: Attn: PANZYGA
PO Box 29309
Mission, KS 66201

PP-PAN-USA-0832

October 2023