Privigen IVIg Therapy FAQ–Indications, Contraindications, Precautions

Q:

What is Privigen?

A:

Privigen is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration.

Q:

What is Privigen indicated for?

A:

Privigen is FDA-approved for the following indications:

  • 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
  • For the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment
    • Limitation of use: maintenance therapy in CIDP has not been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response
  • For the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts
Q:

What are the contraindications for receiving treatment with Privigen?

A:
  • Privigen is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin
  • Because it contains the stabilizer L-proline, Privigen is contraindicated in patients with hyperprolinemia
  • Privigen is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity
Q:

What possible drug interactions with Privigen have been identified?

A:

Treatment with Privigen might interfere with a patient's response to live virus vaccines, such as measles, mumps, rubella, and varicella. Inform the immunizing physician of recent therapy with Privigen so that appropriate measures can be taken.

Q:

How much IgG and IgA does Privigen contain?

A:

Privigen has a purity of at least 98% IgG, consisting primarily of monomers. Privigen contains ≤25 mcg/mL IgA.

Q:

Does Privigen contain any sucrose or maltose?

A:

No, in fact, Privigen contains no sugar. Privigen is the first and only 10% liquid IVIg therapy stabilized with proline.

Privigen Infusion FAQ–Administration, Monitoring Patients

Q:

How is Privigen administered?

A:

Privigen is for intravenous (IV) administration and should be infused by a separate infusion line. It should never be mixed with other IV medications, including other types of IVIg. Privigen may be diluted with D5W. Privigen should be at room temperature (up to 25° C [77° F]) at the time of administration.

An infusion pump may be used to control the rate of administration. The Privigen infusion line can be flushed with Dextrose Injection, USP (D5W) or 0.9% Sodium Chloride for Injection, USP.

If large doses of Privigen are to be administered, several vials may be pooled using aseptic technique. Infusion should begin within 8 hours of pooling. See Dosing and Infusion for more information.

Q:

What adverse reactions should my patient be monitored for throughout treatment?

A:

The patient's vital signs should be observed and monitored carefully for hypersensitivity reactions throughout the infusion (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) as well as infusion-related reactions (including hypotension, chills, and headache). In patients at risk for developing renal failure, monitor urine output and renal function, blood urea nitrogen, and serum creatinine. Also monitor patients with risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.

Patients should be monitored for hemolysis, hemolytic anemia, volume overload, pulmonary adverse reactions, hyperproteinemia, increased serum viscosity, hyponatremia, hypertension, transmissible infectious agents, and interference with lab tests. If transfusion-related acute lung injury (TRALI) is suspected, the patient and product should be tested for anti-neutrophil antibodies and anti-human leukocyte antigen (HLA) antibodies.

Aseptic meningitis syndrome may occur infrequently following treatment with Privigen.

Q:

How long does it take to infuse?

A:

The complete infusion may take several hours and varies with the absolute weight-based dose administered and individual patient tolerability. See Dosing and Infusion for more information.

Q:

At what rate do you infuse Privigen?

A:

Administer IVIg products at the minimum infusion rate possible. Begin at a slow rate of infusion at 0.5 mg/kg/min (0.005 mL/kg/min). Titrate slowly and based on patient tolerability. The maximum infusion rate for patients with PI or CIDP is 8 mg/kg/min (0.08 mL/kg/min); the maximum infusion rate for patients with chronic ITP is 4 mg/kg/min (0.04 mL/kg/min). Monitor patients during infusions. 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. See Dosing and Infusion for complete dosing information or download the guide.

Q:

Can my patients self-administer Privigen?

A:

No. Privigen infusions are administered by a healthcare professional such as a nurse or doctor –at a hospital, clinic, or physician's office, or in the patient’s home.

Financial FAQ–Billing, Support, and Assistance

Q:

How do I bill for Privigen?

A:

The associated CPT®, HCPCS (Healthcare Common Procedural Coding System), and ICD-10-CM codes are based on guidelines from the American Medical Association (AMA) or the Centers for Medicare and Medicaid Services (CMS). The billing party is solely responsible for coding of services (eg, CPT® coding). Because government and other third-party payor coding requirements change periodically, please verify current coding requirements directly with the payor being billed. Review the Privigen Billing and Diagnosis Codes.

Q:

Does CSL Behring provide assistance with Privigen billing?

A:

Yes, IgIQ Support Services can provide coding, billing, and reimbursement information, as well as assistance with insurance verifications and prior authorizations. See IgIQ Support to learn more.

Q:

Where can my patients get more information about financial assistance?

A:

IgIQ Support Services can enroll your patients in programs designed to help patients with access to Privigen therapy. They can also answer other financially related questions. Visit IgIQ Support Services to learn more, or call 1-877-355-IGIQ (4447), Monday–Friday, 8 AM–8 PM ET.

Disease State FAQ–PI, CIDP, chronic ITP, and Treatment Options

Q:

What is primary immunodeficiency disease (PI or PIDD)?

A:

Primary immunodeficiency diseases occur in patients who have an intrinsic defect in the immune system. The immune system may have impaired function in one or more components, or may be absent altogether. There are more than 300 different PIs currently recognized by the World Health Organization–some are common, others are quite rare. See About PI for more information.2,3

Q:

How is PI treated?

A:

Patients with PI who are unable to produce adequate amounts and/or properly functioning antibodies may benefit from replacement therapy with immunoglobulin.4

Visit About PI for a full understanding of how PI is treated.

Q:

How common is PI?

A:

It is estimated that approximately 250,000 individuals (or 1 in 1,200) in the United States have been diagnosed with PI. Although rare, PI is not as uncommon as once believed.28

Q:

What are the different types of PI?

A:

There are more than 300 different PIs currently recognized by the World Health Organization—some are common, others are quite rare. See About PI for more information.3

Q:

What is chronic inflammatory demyelinating polyneuropathy (CIDP)?

A:

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder with an underlying autoimmune basis: the immune system perceives myelin as foreign and attacks it. Damaged myelin ultimately prevents effective communication within the nervous system, which results in the progressive weakness and a loss of sensory function characteristic of CIDP.8,9 See About CIDP for more information.

Q:

How is CIDP treated?

A:

Ig therapy is currently the only FDA-approved treatment for CIDP. Ig therapy contains naturally occurring antibodies obtained from healthy donors and is administered intravenously with the intent of limiting the damage to peripheral nerves and helping improve motor function. See About CIDP for a better understanding of how CIDP is treated.8,9

Q:

How common is CIDP?

A:

CIDP is a rare disease with about 1–2 new cases per 100,000 people per year. However, the disease can be asymptomatic for years prior to diagnosis, so the actual prevalence may be as high as 9 in 100,000 people.8

Q:

What is immune thrombocytopenic purpura (ITP)?

A:

ITP is an autoimmune disorder characterized by immunologic destruction of blood platelets.

Patients with ITP often exhibit purpura (purple bruises) on the skin and mucous membranes and petechiae (red or purple dots) on the skin.

The abbreviation ITP has been defined in various ways: "immune thrombocytopenic purpura," "idiopathic thrombocytopenic purpura," and, most recently, "immune thrombocytopenia," though all these variations refer to the same underlying disease.10

Q:

What are the 3 types of ITP?

A:

There are 3 forms of ITP: newly diagnosed, persistent, and chronic. Newly diagnosed lasts 3 months or less. Persistent lasts from 3 to 12 months. Chronic lasts 12 months or longer.11

At the time of the Privigen pivotal trial for chronic ITP, that form was defined as lasting 6 months or more beyond diagnosis, so the chronic ITP disease criteria for the patient population of that study followed that previous (>6 month) definition.12

Q:

How is chronic ITP treated?

A:

Treatment for chronic ITP depends on the platelet count and the frequency and amount of bleeding experienced by the patient. Adults and children with mild ITP may not need any treatment aside from observation of symptoms and platelet counts (eg, watchful waiting). Those with more severe ITP, low platelet counts, and/or bleeding problems are usually treated.

Treatments include corticosteroids, intravenous immunoglobulin (IVIg), intravenous anti-D immunoglobulin, rituximab, or newer medicines like eltrombopag and romiplostim. Platelet transfusions may be needed in severe cases.11,13 See About ITP for additional information on IVIg therapy.

Q:

What health risks are associated with ITP?

A:

For the majority of children and adults, ITP is not serious or life-threatening. The most severe and life-threatening potential complication is intracranial bleeding. Acute ITP in children often resolves within a few months and does not recur. For a small number of children with ITP, further medical or surgical treatment may be required. Chronic ITP varies from person to person and can last many years.10

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