Dosing and product information
Recommended dosage1
For intravenous use only.
- DOSE300-800 mg/kg (3-8 mL/kg) every 3-4 weeks
- FIRST INFUSION1 mg/kg/min (0.01 mL/kg/min) for 30 minutes; increase every 30 minutes to a maximum of 8 mg/kg/min (0.08 mL/kg/min) as tolerated
- MAXIMUM INFUSION RATE8 mg/kg/min (4.8 mL/kg/h)
- SUBSEQUENT INFUSIONS2 mg/kg/min (0.02 mL/kg/min) for 15 minutes; increase every 15 minutes to a maximum of 8 mg/kg/min (0.08 mL/kg/min) as tolerated
Quality characteristics
QIVIGY is:
Glycine-stabilized and does not contain any sugars or preservatives1
Supplied in 5- and 10-gram single-dose vials1
A high-purity (≥96% IgG) IVIG that contains trace amounts of IgA (≤50 mg/L)1
Manufactured with 4 steps of viral removal/inactivation1
National Drug Codes (NDC) for QIVIGY1
| Presentations | NDC Number of Carton | NDC Number of Label |
|---|---|---|
| 50 mL vial containing 5 grams of protein | 76179-010-01 | 76179-010-02 |
| 100 mL vial containing 10 grams of protein | 76179-010-03 | 76179-010-04 |
Dosing calculator
- In the pivotal trial, QIVIGY was studied using a 30-minute infusion rate escalation protocol for the first infusion and a 15-minute infusion rate escalation protocol for subsequent infusions.1
- Infusion rates should be increased only if the infusion is well tolerated.1
Rate Escalation Protocol: First Infusion
| Elapsed Time (min) | QIVIGY Infusion Rate | |
|---|---|---|
| mL/kg/min | mg/kg/min | |
| 0-29 | 0.01 | 1.0 |
| 30-59 | 0.02 | 2.0 |
| 60-89 | 0.04 | 4.0 |
| 90-119 | 0.06 | 6.0 |
| 120+ (maximum infusion rate) | 0.08 | 8.0 |
Rate Escalation Protocol: Subsequent Infusions
| Elapsed Time (min) | QIVIGY Infusion Rate | |
|---|---|---|
| mL/kg/min | mg/kg/min | |
| 0-14 | 0.02 | 2.0 |
| 15-29 | 0.04 | 4.0 |
| 30-44 | 0.06 | 6.0 |
| 45+ (maximum infusion rate) | 0.08 | 8.0 |
Infusion Considerations1
- Hydrate the patient adequately prior to the initiation of infusion.
- Monitor patient vital signs throughout the infusion.
- The rate of infusion can be related to certain severe adverse drug reactions. Slow or stop infusion if adverse reactions occur.
- If symptoms subside promptly, resume infusion at a lower rate as tolerated by the patient.
- The observation time of patients after QIVIGY administration may vary. If the patient (a) has not received QIVIGY or another IgG product, (b) is switched from an alternative IGIV product or (c) has had a long interval since the previous infusion, prolong the observation time for adverse reactions after QIVIGY infusion.
- Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thrombosis, administer QIVIGY at the minimum dose and infusion rate practicable and discontinue QIVIGY if renal function deteriorates.
Ordering QIVIGY
QIVIGY is available through a limited network of distributors, group purchasing organizations, specialty pharmacies, and ambulatory infusion centers. For more information, please contact the Kedrion customer service team.
Customer service
The Kedrion customer service team is here to help.
GENERAL INFORMATION
For more information, call 866-398-0825 or email US_CustomerService@kedrion.com
MEDICAL INFORMATION
For Medical Information requests, including AMCP Dossier requests, please call 866-398-0825, or email US_MedicalInfo@kedrion.com
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Reference: 1. QIVIGY [prescribing information]. Kedrion Biopharma Inc.; 2025.