Drug Detail:Panzyga (igiv) (Immune globulin (igiv) (intravenous) [ im-myoon-glob-yoo-lin ])
Generic Name: HUMAN IMMUNOGLOBULIN G 100mg in 1mL
Dosage Form: injection
Drug Class: Immune globulins
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.
