Panzyga – One of the FDA-approved drugs to treat Autoimmune diseases

PANZYGA (Immune Globulin Intravenous (IGIV)) is used for the treatment of chronic immune thrombocytopenia (cITP) in adults to increase platelet counts to control and prevent bleeding; primary humoral immunodeficiency (PI) in patients 2 years of age and older (this includes common variable immunodeficiency Wiskott-Aldrich syndrome, congenital agammaglobulinemia, X-linked agammaglobulinemia, and several other combined immunodeficiencies); and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.

• Thrombosis (clotting of the blood) may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include prolonged immobilization, advanced age history of venous or arterial thrombosis, indwelling central vascular catheters use of estrogens, hypercoagulable conditions, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur even in absence of the above-mentioned risk factors.

• If you’re at risk of getting thrombosis, renal dysfunction, or acute renal failure, receive PANZYGA at the minimum dose and infusion rate practicable (ensure adequate hydration before receiving PANZYGA). Your doctor will monitor you for signs and symptoms of thrombosis and also assess blood viscosity if you’re at risk for hyperviscosity.

• If you’re someone who receives IGIV products (including PANZYGA), you should know that (acute renal failure, renal dysfunction, osmotic nephrosis, and death may occur). IGIV products can contain sucrose and patients who receive these products can commonly get renal dysfunction and renal failure (PANZYGA does not contain sucrose). Patients liable to renal dysfunction include those with pre-existing renal insufficiency, volume depletion, age greater than 65, diabetes mellitus, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

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

• Your doctor will monitor renal function, blood urea nitrogen, serum creatinine, and urine output if you’re at risk of developing acute renal failure.

• Hemolysis can develop subsequent to PANZYGA treatments. Your doctor will closely monitor you for hemolysis and hemolytic anemia. Risk factors for hemolysis include high doses and the non-O-blood group.

• Increased serum osmolarity, Hyperproteinemia, and hyponatremia may occur in patients receiving PANZYGA. Patients receiving PANZYGA, at higher doses or rapid infusion may get aseptic meningitis syndrome

• Your doctor will monitor you for pulmonary reactions (transfusion-related acute lung injury [TRALI]).

• Make sure to monitor your blood pressure prior to, during, and following PANZYGA administration.

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

• Consider the risks and benefits before prescribing/receiving the high dose regimen for cITP (as patients are at increased risk of volume overload).

• cITP in adults – The most common side effects were nausea, vomiting, dizziness, headache, fever, and anemia.

• PI – The most common side effects were abdominal pain, nausea, fever, headache, fatigue, and abdominal pain.

• CIDP in adults – The most common side effects were headache, fever, dermatitis, and an increase in blood pressure.

• PANZYGA should be administered separately from other drugs or medications which the patient might be receiving.

• Passively transferred antibodies in immunoglobulin preparations can confound the results of serological testing, e.g. false positive.

• Treponema pallidum testing might occur.

• PANZYGA shouldn’t be mixed with IGIVs from other manufacturers.

• Antibodies in PANZYGA may interfere with live viral vaccines, such as measles, mumps, and rubella. Inform your physician if you’re planning to get live viral vaccines so it can be delayed for 3 or more months from the time of PANZYGA administration.

It is also not known whether PANZYGA can cause fetal harm when given to a pregnant woman or if it can pass through the milk while breastfeeding.