Panzyga
Pronunciation: Pan-zee-ga
Generic name: Immune globulin intravenous (IGIV)
Dosage form: 10% liquid preparation for intravenous infusion
Drug class: Immune globulins
What is Panzyga?
Panzyga is used to treat primary humoral immunodeficiency (PI), chronic immune thrombocytopenia (cITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). It is a liquid human immune globulin preparation given by intravenous infusion every 3 to 4 weeks for PI and on 2 consecutive days for chronic ITP and initially for CIDP.
- Panzyga helps to prevent certain infections and increases platelets (blood clotting cells).
While the exact way Panzyga works for PI, cITP, or CIDP isn't fully understood, it provides the body with a wide range of protective antibodies. These IgG antibodies help fight bacteria and their harmful toxins when given directly into the bloodstream. Panzyga belongs to a class of medications called immune globulins.
Panzyga (Immune Globulin Intravenous [Human] - ifas) first gained FDA approval in 2018 for PI and cITP. Approval was extended in February 2021 for CIDP.
FDA approvals and uses
Panzyga is approved to treat:
- primary humoral immunodeficiency (PI) in adults and children aged 2 years and older. This includes, but is not limited to:
- congenital agammaglobulinemia
- common variable immunodeficiency
- X-linked agammaglobulinemia
- Wiskott-Aldrich syndrome
- severe combined immunodeficiencies.
- chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding
- chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.
Side effects
The most common side effects of Panzyga in PI are:
- Headache
- Nausea
- Fever
- Fatigue
- Abdominal pain.
The most common side effects of Panzyga in cITP are:
- Headache
- Fever
- Nausea
- Vomiting
- Dizziness
- Anemia.
The most common side effects of Panzyga in CIDP are:
- Headache
- Fever
- Dermatitis
- Blood pressure increases.
Serious side effects and warnings
Panzyga carries a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure.
Panzyga can cause blood clots (thrombosis). The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bed rest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.
- Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.
Panzyga can also harm your kidneys, especially if you have kidney disease or you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.
- Patients with a higher risk include those with a pre-existing kidney disease, diabetes, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving drugs that are toxic to the kidneys. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Panzyga does not contain sucrose.
- Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure.
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.
Panzyga may also cause the following serious side effects:
- Allergic reactions. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
- Infusion reactions. Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.
- A blood cell disorder. Call your healthcare provider if you develop pale or yellowed skin, dark colored urine, fever, confusion, or weakness;
- Dehydration symptoms. Call your healthcare provider if you feel very thirsty or hot, are unable to urinate, sweat heavily, or have hot and dry skin.
- Lung problems. Symptoms include chest pain, trouble breathing, blue colored lips, fingers, or toes. Tell your healthcare provider immediately.
- Signs of a new infection. Seek urgent medical attention if you develop fever with a severe headache, neck stiffness, eye pain, or increased sensitivity to light.
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 after Panzyga treatments. Risk factors for hemolysis include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia.
Monitor blood pressure before, 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, such as viruses, and theoretically, the Creutzfeldt-Jakob disease agent.
These are not all the side effects of Panzyga. Report side effects to Pfizer or 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.
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Before receiving
Do not receive Panzyga if you have:
- had an allergic reaction to an immune globulin or blood product;
- immune globulin A (IgA) deficiency with antibodies to IgA
Panzyga can cause blood clots or kidney problems, especially in older adults or people with certain conditions. Tell your doctor if you:
- have ever had heart problems, blood circulation problems, or "thick blood"
- have ever had a stroke or a blood clot
- have ever had kidney disease
- have ever had diabetes
- have ever had an infection called sepsis
- use estrogens (birth control pills or hormone replacement therapy)
- have been on long-term bed rest
- have a central intravenous (IV) catheter in place.
You may need a dose adjustment if you are exposed to measles or if you travel to an area where this disease is common.
Tell your doctor if you are pregnant or breastfeeding.
Panzyga is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.
How do I receive Panzyga?
Panzyga is given as an infusion into a vein every 3 to 4 weeks for PI and on 2 consecutive days for chronic ITP and initially for CIDP. A healthcare provider will give you this injection.
- Drink plenty of liquids while you are using Panzyga to help improve your blood flow and keep your kidneys working properly.
- You may need frequent blood or urine tests.
- This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using IGIV.
Dosing information
Before starting Panzyga, your healthcare provider should ensure you are not dehydrated, especially if you have pre-existing kidney disease. Panzyga should be stopped if your kidney function gets worse.
For patients at risk of renal dysfunction or thrombotic events, Panzyga should be administered at the minimum dose and infusion rate practicable.
Dose of Panzyga for Primary Humoral Immunodeficiency (PI) in Adults and Children 2 years and older
- 300-600 mg/kg (3-6 mL/kg) every 3-4 weeks.
- Initial infusion rate: 1 mg/kg/min (0.01 mL/kg/min)
- Maximum infusion rate (as tolerated): 14 mg/kg/min (0.14 mL/kg/min)
Dose of Panzyga for Chronic ITP in Adults
- 2 g/kg (20 mL/kg) divided into 2 daily doses of 1 g/kg (10 mL/kg) given on 2 consecutive days.
- Initial infusion rate: 1 mg/kg/min (0.01 mL/kg/min)
- Maximum infusion rate (as tolerated): 8 mg/kg/min (0.08 mL/kg/min)
Dose of Panzyga for CIDP in Adults
- Loading dose: 2 g/kg (20 mL/kg) divided into 2 daily doses of 1 g/kg (10 mL/kg) given on 2 consecutive days.
- Maintenance dose: 1-2 g/kg (10-20 mL/kg) every 3 weeks divided in 2 doses given over 2 consecutive days.
- Initial infusion rate: 1 mg/kg/min (0.01 mL/kg/min)
- Maximum infusion rate (as tolerated): 12 mg/kg/min (0.12 mL/kg/min)
What should I avoid while using Panzyga?
Ask your doctor before receiving a "live" vaccine while using IGIV. The vaccine may not work as well and may not fully protect you from the disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and the nasal flu (influenza) vaccine.
What other drugs will affect Panzyga?
Other drugs may affect Panzyga, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Panzyga can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).
Who makes Panzyga?
Panzyga is manufactured by Octapharma Pharmazeutika Produktionsges m.b.H. and distributed by Pfizer Labs, Division of Pfizer Inc.
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