6 FILE(S)

Send To My Email

• 

  PHYSICIAN MATERIALS Privigen Coding Guide

• 

  PHYSICIAN MATERIALS Privigen Infusion Rate Brochure

• 

  PHYSICIAN MATERIALS CSL IVIg/SCIg Options for CIDP

• 

  PHYSICIAN MATERIALS Privigen Referral Form

• 

  PATIENT MATERIALS Privigen Patient Brochure—CIDP

• 

  SAVINGS & SUPPORT Privigen Patient Savings & Support

Privigen is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of:

• Primary humoral immunodeficiency (PI)
• Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
• Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
  • Limitations 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.

 

Please see full prescribing information, including boxed warning.

DOSAGE AND ADMINISTRATION

Recommended dosage and infusion rates

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)

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. Titrate based on patient tolerability.

For patients at risk of thrombosis, renal dysfunction, or renal failure, administer Privigen at the minimum dose and infusion rate practicable, and discontinue Privigen administration if renal function deteriorates.

Per the protocols for the Privigen clinical trials, the initial infusion rate was 0.5 mg/kg/min for each infusion. The rate could then be doubled every 30 minutes up the maximum allowable rate (either 8 mg/kg/min for PI and CIDP or 4 mg/kg/min for ITP) based on patient tolerability and healthcare provider clinical judgement.

 

Please see full prescribing information, including boxed warning.

WARNINGS AND PRECAUTIONS

• Severe hypersensitivity reactions may occur. In case of hypersensitivity, discontinue the Privigen infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions
• Immunoglobulin A (IgA)-deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Privigen contains a trace amount of IgA (≤25 mcg/mL)
• Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIg therapy
• Aseptic meningitis syndrome (AMS) may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IVIg. AMS usually begins within several hours to 2 days following IVIg treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae
• Hemolysis can develop subsequent to Privigen treatments due to enhanced red blood cell sequestration. Monitor patients for hemolysis and hemolytic anemia. The following risk factors may be associated with the development of hemolysis: high doses (e.g., ≥2 g/kg), given either as a single administration or divided over several days, and non-O blood group
• Elevations of systolic and/or diastolic blood pressure (including cases of hypertensive urgency) have been observed during/shortly following Privigen infusion. These blood pressure elevations were resolved or significantly improved within hours with either observation alone or changes in oral anti-hypertensive therapy. Check patients for a history of hypertension and/or current use of antihypertensive medication and monitor blood pressure prior, during, and following Privigen infusion
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). Symptoms typically appear within 1 to 6 hours following treatment
• Volume overload: Carefully consider the relative risks and benefits before prescribing the high dose regimen (for chronic ITP and CIDP) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload
• Because Privigen is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt Jakob disease [CJD] agent). The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Privigen
• Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing
• The passive transfer of antibodies with immunoglobulin administration may interfere with the response to live virus vaccines such as measles, mumps, rubella, and varicella

 

Please see full prescribing information, including boxed warning.