May 31, 2016
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Privigen

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Privigen




Indications
Dosage
How Supplied

INDICATIONS

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 with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.

DOSAGE AND ADMINISTRATION

Table 1: Recommended Dosage and Administration for Privigen

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)

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.

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].

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 25°C [77°F]) 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].

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.

HOW SUPPLIED

Dosage Forms And Strengths

Privigen is a liquid solution containing 10% IgG (0.1 g/mL) for intravenous infusion.

  • Privigen is supplied in a single-use, tamper-evident vial containing the labeled amount of functionally active IgG.

Each product presentation includes a package insert and the following components:

Presentation Carton NDC Number Components
50 mL 44206-436-05 Vial containing 5 grams of protein (NDC 44206-436-90)
100 mL 44206-437-10 Vial containing 10 grams of protein (NDC 44206-437-91)
200 mL 44206-438-20 Vial containing 20 grams of protein (NDC 44206-438-92)
400 mL 44206-439-40 Vial containing 40 grams of protein (NDC 44206-439-93)

Storage And Handling

  • Keep Privigen in its original carton to protect it from light.
  • Each vial has an integral suspension band and a label with two peel-off strips showing the product name, lot number, and expiration date.
  • When stored at room temperature (up to 25°C [77°F]), Privigen is stable for up to 36 months, as indicated by the expiration date printed on the outer carton and vial label.
  • Do not freeze.
  • The Privigen packaging components are not made with natural rubber latex.

Manufactured by: CSL Behring AG, Bern, Switzerland. Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA. Revised: Nov 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/18/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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