Dosage & Administration
Intravenous Use Only
| Indication | Dose | Initial Infusion Rate | Maintenance Infusion Rate (as tolerated) |
|---|---|---|---|
| PI | 200-800 mg/kg (2-8 mL/kg) every 3-4 weeks | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 8 mg/kg/min (0.08 mL/kg/min) |
| ITP | 1 g/kg (10 mL/kg) for 2 consecutive days | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 4 mg/kg/min (0.04 mL/kg/min) |
| CIDP | Loading dose: 2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days Maintenance dose: 1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 8 mg/kg/min (0.08 mL/kg/min) |
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Privigen Prescribing Information
Thrombosis may occur with immune globulin products1-3, including PRIVIGEN. 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 (5.3), Patient Counseling Information (17)].
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. 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.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.4 PRIVIGEN does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or failure, administer PRIVIGEN 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 (2.5), Warnings and Precautions (5.2, 5.3)].
PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.
Primary Humoral Immunodeficiency
PRIVIGEN is indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Chronic Immune Thrombocytopenic Purpura
PRIVIGEN is indicated for the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
Chronic Inflammatory Demyelinating Polyneuropathy
PRIVIGEN is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
Limitation of Use:
PRIVIGEN maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with PRIVIGEN in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient's response and demonstrated need for continued therapy.
| Indication | Dose | Initial infusion rate | Maintenance infusion rate (as tolerated) |
|---|---|---|---|
| Primary Immunodeficiency | 200-800 mg/kg (2-8 mL/kg) every 3-4 weeks | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 8 mg/kg/min (0.08 mL/kg/min) |
| Chronic Immune Thrombocytopenic Purpura | 1 g/kg (10 mL/kg) for 2 consecutive days | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 4 mg/kg/min (0.04 mL/kg/min) |
| Chronic Inflammatory Demyelinating Polyneuropathy | Loading dose: 2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days Maintenance dose: 1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks | 0.5 mg/kg/min (0.005 mL/kg/min) | Increase to 8 mg/kg/min (0.08 mL/kg/min) |
Dosage for Primary Humoral Immunodeficiency (PI)
As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.
The recommended dose of PRIVIGEN for patients with PI is 200 to 800 mg/kg (2 to 8 mL/kg), administered every 3 to 4 weeks. 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.
Adjust the dosage over time to achieve the desired serum IgG trough levels and clinical responses. No randomized, controlled trial data are available to determine an optimal trough level in patients receiving immune globulin therapy.
Measles Exposure
If a patient has been exposed to measles, it may be prudent to administer an extra dose of Immune Globulin Intravenous 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 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.
Dosage for Chronic Immune Thrombocytopenic Purpura (ITP)
The recommended dose of PRIVIGEN for patients with chronic ITP is 1 g/kg (10 mL/kg) administered daily for 2 consecutive days, resulting in a total dosage of 2 g/kg.
Carefully consider the relative risks and benefits before prescribing the high dose regimen (e.g., 1 g/kg/day for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload [see Warnings and Precautions (5.9)].
Dosage for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
PRIVIGEN may be initially administered as a total loading dose of 2 g/kg (20 mL/kg) given in divided doses over two to five consecutive days. PRIVIGEN may be administered as a maintenance infusion of 1 g/kg (10 mL/kg) administered in a single infusion given in one day or divided into two doses given on two consecutive days, every 3 weeks. Maintenance therapy beyond 6 months has not been studied.
The recommended initial infusion rate is 0.5 mg/kg/min (0.005 mL/kg/min). If the infusion is well tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for thrombosis, renal dysfunction, or volume overload, administer PRIVIGEN at the minimum infusion rate practicable [see Warnings and Precautions (5.2, 5.3)].
Preparation and Handling
- PRIVIGEN is a clear or slightly opalescent, colorless to pale yellow solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy, turbid, or if it contains particulate matter.
- DO NOT SHAKE.
- Do not freeze. Do not use if PRIVIGEN has been frozen.
- PRIVIGEN should be at room temperature (up to 25ºC [77ºF]) at the time of administration.
- Do not use PRIVIGEN beyond the expiration date on the product label.
- The PRIVIGEN vial is for single-use only. Promptly use any vial that has been entered. PRIVIGEN contains no preservative. Discard partially used vials or unused product in accordance with local requirements.
- Infuse PRIVIGEN using a separate infusion line. Prior to use, the infusion line may be flushed with Dextrose Injection, USP (D5W) or 0.9% Sodium Chloride for Injection, USP.
- Do not mix PRIVIGEN with other IGIV products or other intravenous medications. However, PRIVIGEN may be diluted with Dextrose Injection, USP (D5W).
- An infusion pump may be used to control the rate of administration.
- If large doses of PRIVIGEN are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 8 hours of pooling.
Administration
PRIVIGEN is for intravenous administration only.
Monitor the patient's vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombosis, administer PRIVIGEN at the minimum dose and infusion rate practicable, and discontinue PRIVIGEN administration if renal function deteriorates [see Boxed Warning, Warnings and Precautions (5.2, 5.3)].
The following patients may be at risk of developing systemic reactions (mimicking symptoms of an inflammatory response or infection) on rapid infusion of PRIVIGEN (greater than 4 mg/kg/min [0.04 mL/kg/min]): 1) those who have never received PRIVIGEN or another IgG product or who have not received it within the past 8 weeks, and 2) those who are switching from another IgG product. These patients should be started at a slow rate of infusion (e.g., 0.5 mg/kg/min [0.005 mL/kg/min] or less) and gradually increase as tolerated.
PRIVIGEN is a liquid solution containing 10% IgG (0.1 g/mL) for intravenous infusion.
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 PRIVIGEN. It is not known whether PRIVIGEN 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.16,17 PRIVIGEN should be given to pregnant women only if clearly needed. 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 PRIVIGEN and any potential adverse effects on the breastfed infant from PRIVIGEN or from the underlying maternal condition.
Pediatric Use
Treatment of Primary Humoral Immunodeficiency
PRIVIGEN was evaluated in 31 pediatric subjects (19 children and 12 adolescents) with PI (prospective, open label, single arm, multicenter clinical study). There were no apparent differences in the safety and efficacy profiles as compared to those in adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. The safety and effectiveness of PRIVIGEN have not been studied in clinical trials in pediatric patients with PI who are under the age of 3.
Treatment of Chronic Immune Thrombocytopenic Purpura
The safety and effectiveness of PRIVIGEN have not been established in pediatric patients with chronic ITP who are under the age of 15.
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
The safety and effectiveness of PRIVIGEN have not been established in pediatric patients with CIDP who are under the age of 18.
Geriatric Use
Clinical studies of PRIVIGEN in PID and ITP did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.
The safety and effectiveness of PRIVIGEN in CIDP subjects age 65 and over was similar to those under age 65.
Use caution when administering PRIVIGEN to patients age 65 and over who are judged to be at increased risk of developing acute renal insufficiency and thrombosis [see Boxed Warning, Warnings and Precautions (5.2, 5.3)]. Do not exceed recommended doses, and administer PRIVIGEN at the minimum dose and infusion rate practicable.
- PRIVIGEN is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin.
- PRIVIGEN is contraindicated in patients with hyperprolinemia because it contains the stabilizer L-proline [see Description (11)].
- PRIVIGEN is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity [see Warnings and Precautions (5.1)].