Dosage & Administration
For intravenous use only .
| Indication | Dose | Initial Infusion Rate | Maximum Infusion Rate (as tolerated) |
| PI | 300-600 mg/kg (3-6 mL/kg)every 3-4 weeks | 1 mg/kg/min (0.01 mL/kg/min) | 14 mg/kg/min (0.14 mL/kg/min) |
| 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 | 1 mg/kg/min (0.01 mL/kg/min) | 8 mg/kg/min (0.08 mL/kg/min) |
| 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 | 1 mg/kg/min (0.01 mL/kg/min) | 12 mg/kg/min (0.12 mL/kg/min) |
•Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue PANZYGA if renal function deteriorates .
•For patients at risk of renal dysfunction or thrombotic events, administer PANZYGA at the minimum dose and infusion rate practicable .
Panzyga Prescribing Information
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. (See WARNING and PRECAUTIONS [ 5.4], PATIENT COUNSELING INFORMATION [ 17])
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 product 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 DOSAGE and ADMINISTRATION [ 2.3], WARNINGS and PRECAUTIONS [ 5.2, 5.4])
Primary Humoral Immunodeficiency Diseases (PI)
PANZYGA is indicated for 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 (ITP)
PANZYGA is indicated for the treatment of adult patients with ITP to raise platelet counts to control or prevent bleeding.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
PANZYGA is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
For intravenous use only.
Dose
| Indication | Dose | Initial Infusion Rate (first 30 min) | Maximum Infusion Rate (as tolerated) |
| Treatment of Primary Humoral Immunodeficiency (PI)* | 300 to 600 mg/kg body weight (3-6 mL/kg) administered every 3 to 4 weeks | 1 mg/kg/min (0.01 mL/kg/min) | 14 mg/kg/min (0.14 mL/kg/min) |
| Treatment of Chronic Immune Thrombocytopenia (ITP) | 2 g/kg (20 mL/kg), divided into 2 daily doses of 1 g/kg (10 mL/kg) given on 2 consecutive days | 1 mg/kg/min (0.01 mL/kg/min) | 8 mg/kg/min (0.08 mL/kg/min) |
| Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 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 daily doses given over 2 consecutive days | 1 mg/kg/min (0.01 mL/kg/min) | 12 mg/kg/min (0.12 mL/kg/min) |
*Significant differences in the half-life of IgG among patients with PI may necessitate the dose and frequency of immunoglobulin therapy to vary from patient to patient. Determine the proper dose and frequency by monitoring the clinical response. Adjust dose over time to achieve the desired trough levels of IgG and clinical responses.
The initial infusion rate should be maintained for 30 min. Following the initial infusion, and if tolerated, the infusion rate may be gradually increased every 15-30 minutes, as tolerated to the maximum infusion rate shown in the table above for each indication.
Measles Exposure.
If a patient with primary humoral immunodeficiency has been exposed to measles, it may be prudent to administer an extra dose of IGIV as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level > 240 mIU/mL of measles antibodies for at least two weeks.
If a patient with primary humoral immunodeficiency is at risk of future measles exposure and receives a dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion.
Administration
- Inspect parenteral products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use PANZYGA if it is turbid and/or if discoloration is observed. Using a needle, no larger than a 16-gauge needle, insert the needle only once within the stopper area (delineated by the raised ring for penetration). Penetrate the stopper perpendicularly to its plane and within the ring.
- PANZYGA bottles may be pooled under aseptic conditions into sterile infusion bags. Infuse within 8 hours after pooling.
- Administer at room or body temperature only by the intravenous route
- PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns.
- Do not administer PANZYGA simultaneously with another intravenous preparation in the same infusion set, including immune globulin products from another manufacturer.
- After administration, the infusion line may be flushed with either normal saline or 5% dextrose in water.
- Monitor the patient carefully throughout the infusion. Certain adverse drug reactions are related to the rate of infusion, and will disappear promptly after slowing or stopping the infusion. In such cases, after symptoms subside, resume the infusion at a lower rate. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thromboembolic events, administer PANZYGA at the minimum infusion rate practicable [see Warnings and Precautions (5.2, 5.4)] . Do not exceed 3.3 mg/kg/min (0.033 mL/kg/min). Discontinue if renal function deteriorates.
Solution containing 10% IgG (100 mg/mL) (See How Supplied/Storage and Handling ).
Pregnancy
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with PANZYGA. It is also not known whether PANZYGA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lactation
Risk summary
No human data are available to indicate the presence or absence of drug-associated risk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PANZYGA and any potential adverse effects on the breastfed infant from PANZYGA or from the underlying maternal condition.
Pediatric Use
Treatment of Primary Humoral Immunodeficiency (PI)
PANZYGA was evaluated in 25 pediatric subjects (age range: 2-15 years). Twenty-five percent of PI subjects exposed to PANZYGA were children (between 2 and 12 years of age). Pharmacokinetics, efficacy and safety were similar to those in adults. No specific dose requirements were necessary to achieve the targeted serum IgG levels in the pediatric subjects.
Treatment of Immune Thrombocytopenia (ITP) in children
The safety and effectiveness of PANZYGA have not been established in pediatric patients with ITP.
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in children
The safety and effectiveness of PANZYGA have not been established in pediatric patients with CIDP.
Geriatric Use
Clinical studies of PANZYGA in PID and ITP did not include sufficient numbers of subjects older than 65 years to determine whether they respond differently from younger subjects.
In the clinical study the safety and effectiveness of PANZYGA in subjects with CIDP older than 65 years was similar to those 65 years of age and younger. A total of 36 subjects older than 65 years were included in the clinical trial.
Patients older than 65 years of age may be at increased risk for developing adverse reactions such as thromboembolic events and acute renal failure (See Boxed Warnings and Thrombotic Events and Renal Failure . Do not exceed recommended doses in this population, and apply the minimum practicable infusion rate.
- PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin.
- PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.