Human immunoglobulin g
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin products, including QIVIGY. 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 Warnings and Precautions (5.2) ] . Renal dysfunction, acute renal failure, osmotic nephrosis may occur with immune globulin intravenous (IGIV) products in predisposed patients.
Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.3) ] . For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum 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 Warnings and Precautions (5.2 , 5.3) ] . WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE See full prescribing information for complete boxed warning. Thrombosis may occur with immune globulin products, including QIVIGY. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors .
( 5.2 ) Renal dysfunction, acute renal failure, osmotic nephrosis may occur in predisposed patients with immune globulin intravenous (IGIV) products, including QIVIGY. Such events require immediate medical intervention; if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome. ( 5.3 ) For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer QIVIGY 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 . ( 5.2 , 5.3 )
Human Immunoglobulin G
Dosing in kidney impairment
In case of renal impairment, IGIV discontinuation should be considered [see Administration and Warnings and Precautions (2.3 , 5.3) ]. Measles pre-/post exposure prophylaxis Post-exposure prophylaxis If a patient has been exposed to measles, a dose of 400 mg/kg (4 mL/kg) of QIVIGY should be administered as soon as possible after exposure.
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 [see Boxed Warning , Warnings and Precautions (5.2 , 5.3) ] .
Preparation and administration
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Recommended Dosage [See table below.] 300 - 800 mg/kg every 3-4 weeks From the 2 nd infusion 2 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) Adjust frequency and dosage overtime to achieve target serum IgG levels and clinical response. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.
In patients judged to have a potential increased risk for developing acute renal failure or thrombosis, QIVIGY should be administered at the minimum rate of infusion and dose practicable. In case of renal impairment, IGIV discontinuation should be considered [see Administration and Warnings and Precautions (2.3 , 5.3) ].
Measles pre-/post exposure prophylaxis Post-exposure prophylaxis If a patient has been exposed to measles, a dose of 400 mg/kg (4 mL/kg) of QIVIGY should be administered as soon as possible after exposure. Pre-exposure prophylaxis If a patient routinely receives a dose of less than 400 mg/kg of QIVIGY every 3 to 4 weeks (less than 4 mL/kg) and is at risk of measles exposure (i.e. traveling to a measles endemic area), administer a dose of at least 400 mg/kg (4 mL/kg) just prior to the expected measles exposure.
Preparation and Handling QIVIGY is a clear or slightly opalescent and colorless or pale-yellow solution. Inspect QIVIGY visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not use if the solution is cloudy, turbid, or if it contains particulate matter or deposits.
Do not shake. Do not dilute. QIVIGY should be brought to room temperature before use (up to 25 °C [77 °F]). Keep the vial in the outer carton. If the packaging shows any signs of tampering, do not use the product and notify Kedrion Biopharma Inc. immediately at 1-855-3KDRION (1-855-353-7466). The QIVIGY vial is for single use only.
Any vial that has been opened must be used immediately. QIVIGY contains no preservative. For administration of large doses, pool multiple vials using aseptic technique Infuse QIVIGY using a separate infusion line. At the end of the infusion flush tubing with saline solution or Dextrose 5% in water (D5W) to ensure that the entire dose is administered.
Do not mix QIVIGY with other IGIV products or other intravenous medications (including normal saline) Do not use after expiration date. Record the batch number every time QIVIGY is administered to a patient. Dispose partially used or unused product or waste material in accordance with local requirements.
Administration Intravenous administration only . Hydrate the patient adequately prior to the initiation of infusion. Infuse QIVIGY intravenously using an intravenous infusion set. See Table 1 for recommended infusion rates. 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 [see Boxed Warning , Warnings and Precautions (5.2 , 5.3) ] .
| Dose | Infusion number | Initial Infusion Rate | Maintenance Infusion Rate (as tolerated) |
|---|---|---|---|
| 300 - 800 mg/kg every 3-4 weeks | For the 1st infusion | 1 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) |
| 300 - 800 mg/kg every 3-4 weeks | From the 2nd infusion | 2 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) |
| Dose | Infusion number | Initial Infusion Rate | Maintenance Infusion Rate (as tolerated) |
|---|---|---|---|
| 300 - 800 mg/kg every 3-4 weeks | For the 1st infusion | 1 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) |
| 300 - 800 mg/kg every 3-4 weeks | From the 2nd infusion | 2 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) |
Drug interactions
Check human immunoglobulin g against a medication listLabel text (4 paragraphs)
The passive transfer of antibodies may: Interfere with the response to live virus vaccines, such as measles, rubella, mumps and varicella. ( 7 ) Result in misleading positive results in serological testing. ( 5.9 , 7 )
7.1 Effect of QIVIGY on Live attenuated virus vaccines Immune globulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella, s and varicella because the continued presence of high levels of passively acquired antibody may interfere with an active antibody response. Inform the immunizing physician of recent therapy with QIVIGY so that appropriate measures may be taken.
7.2 Effect of QIVIGY on Serological Testing Passive transmission of antibodies through immune globulin administration may interfere with some serological testing [see Warnings and Precautions (5.10) ].
7.3 Effect of Loop diuretics on QIVIGY The use of loop diuretics should be avoided. Concomitant use of loop diuretics with IGIV may contribute to an increased blood viscosity and subsequently increase the risk of thromboembolic events.
Contraindications
4 CONTRAINDICATIONS QIVIGY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. QIVIGY is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with history of anaphylactic or severe systemic reactions to human immune globulins. ( 4 ) IgA deficient patients with antibodies against IgA and a history of hypersensitivity. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for human immunoglobulin g. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 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 QIVIGY. It is not known whether QIVIGY can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation. QIVIGY should be given to pregnant women only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 - 4% and 15 - 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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