Support 

Frequently asked questions

Pfizer PANZYGA Co‑Pay  Program for patients Resources and tools Frequently asked questions Request a representative

Frequently asked questions about PANZYGA

What are the most common adverse reactions (ARs) seen with PANZYGA?

CIDP in adults1
The most common ARs reported in greater than 5% of subjects during a clinical trial were headache (15%; 21 of 142), fever (14%; 20 of 142), dermatitis (10%; 14 of 142), and blood pressure increase (8%; 11 of 142).

PI in patients age 2 years and older1
The most common ARs observed at a rate of more than 5% in patients in clinical studies were headache (22%; 11 of 51), abdominal pain (14%; 7 of 51), fever (14%; 7 of 51), nausea (10%; 5 of 51), sinusitis (8%; 4 of 51), fatigue (6%; 3 of 51), and bronchitis (6%; 3 of 51).

cITP in adults1
The most common ARs observed at a rate of more than 5% in patients in clinical studies were headache (50%; 20 of 40), fever (23%; 9 of 40), nausea (18%; 7 of 40), vomiting (10%; 4 of 40), dizziness (10%; 4 of 40), and anemia (10%; 4 of 40).

One of 40 patients with cITP treated with PANZYGA developed aseptic meningitis on Day 2 of the infusion. This patient was managed with antibiotics and supportive care with recovery.

Is premedication required with PANZYGA infusions?

CIDP study1
During the CIDP study, 11 patients (8%) received premedication. The use of premedication was only allowed under certain conditions. Patients who experienced 2 consecutive infusion-related adverse events that were likely to be prevented by premedication were permitted to receive antipyretics, antihistamines, or antiemetic drugs.

PI studies2
Only 2 patients received premedication (3.9%) for 3 infusions (0.4%) in the PI clinical study.
No patient received premedication in the PI extension study.

cITP study1
Premedication was not allowed in the cITP study.

What vial sizes are available for PANZYGA?

PANZYGA is available in 5 vial sizes to meet individual patient needs: 25 mL (2.5 g), 50 mL (5 g), 100 mL (10 g), 200 mL (20 g), and 300 mL (30 g). PANZYGA is supplied in single-use bottles.1

Where can I get more information about PANZYGA?

Please contact your Pfizer sales representative
Tel: 1-844-646-4398

Or click here to request a representative.

Medical Information
[email protected]
Tel: 1-888-429-4535

How can PANZYGA be purchased?

PANZYGA is available for purchase from specialty distributors.

If your practice includes an infusion suite or physician clinic, learn more about purchasing PANZYGA here.

What if my patients cannot tolerate their PANZYGA infusion and/or infusion rate?

Patients should be carefully monitored throughout the infusion, and the infusion rate should be adjusted if adverse drug reactions related to the rate of infusion occur. The Package Insert for PANZYGA recommends using an appropriate dose the patient can tolerate. Click on the links to get help with PANZYGA dosing and infusion rates for CIDP, PI, and cITP

How is PANZYGA stored?

Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf life, the product may be stored at room temperature (≤+25°C or 77°F) for up to 12 months. After storage at ≤+25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product.1

Is it safe to flush the line with saline after using PANZYGA?

Yes, it is recommended that after administration the infusion line be flushed with either normal saline or 5% dextrose in water.1

Can the standard Y connector be used for the flush?

Yes, the Y connector can be used for the saline or 5% dextrose flush.1

Do not administer PANZYGA simultaneously with another intravenous preparation in the same infusion set, including immune globulin products from another manufacturer.1

Which infusion pumps have been used to administer PANZYGA?

In clinical trials, the following 2 pumps were used: Perfusor® and Infusomat®.

What is the IgA content level in PANZYGA?

The IgA content level of PANZYGA is 100 µg/mL. PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.1

PANZYGA is stabilized with glycine and does not contain preservatives or sucrose.1
Click here to learn more.

What stabilizer does PANZYGA use?

References
  1. PANZYGA [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021.
  2. Borte M, Melamed IR, Pulka G, et al. Efficacy and safety of human intravenous immunoglobulin 10% (Panzyga®) in patients with primary immunodeficiency diseases: a two-stage, multicenter, prospective, open-label study. J Clin Immunol. 2017;37(6):603-612.
IgA=immunoglobulin A.

Request a representative

Request here

Access resources and tools

Access here
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
  • 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 central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including PANZYGA. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. 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 dose and 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. [see Full Prescribing Information, Warnings and Precautions (5.2, 5.4)]

Contraindications

PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Warnings and Precautions

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving PANZYGA.

Aseptic meningitis syndrome may occur in patients receiving PANZYGA, especially with high doses or rapid infusion.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to PANZYGA treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Monitor blood pressure prior to, during, and following PANZYGA infusion.

Carefully consider the relative risks and benefits before prescribing the high dose regimen (for cITP) in patients at increased risk of volume overload.

PANZYGA is made from human plasma and may contain infectious agents, e.g. viruses and theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions

PI – The most common adverse reactions (≥5% study subjects) were headache, nausea, fever, fatigue, and abdominal pain.

cITP in adults – The most common adverse reactions (≥5% study subjects) were headache, fever, nausea, vomiting, dizziness, and anemia.

CIDP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, dermatitis, and blood pressure increase.
​​​​​​​
The risk information provided here is not comprehensive; see full Prescribing Information and Boxed Warning for PANZYGA.

You are encouraged to report adverse events 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. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

PANZYGA® is a registered trademark of Octapharma AG.

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

PANZYGA (Immune Globulin Intravenous [Human] - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.

INDICATION 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; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.