Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, by CSL Behring LLC.


Prefilled Syringe Information
3 FILES

Physician Resources
Patient Resources
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Patient Resources
Administration
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Physician Resources
Savings and Support
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Savings & Support
Boxed Warning

IMPORTANT SAFETY INFORMATION

 

WARNING: Thrombosis may occur with immune globulin products, including Hizentra. 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.

For patients at risk of thrombosis, administer Hizentra 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.

Highlights of Indications & Usage

INDICATIONS AND USAGE

Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:

• Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.

• Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.

o   Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.

Please see full prescribing information for Hizentra including boxed warning.

Highlights of Dosage & Administration

DOSAGE AND ADMINISTRATION FOR PI

For subcutaneous infusion only.

Do not administer intravenously.  Hizentra can be dosed from daily up to every 2 weeks using an infusion pump and relatively small needle(s).

  • The Hizentra dose may be infused into multiple infusion sites depending on volume
  • Infusion sites should be at least 2 inches apart
  • Rotate the actual site of infusion with each administration
  • Use up to 8 infusion sites in parallel. More than 1 infusion device can be used simultaneously
  • Recommend infusion sites include the abdomen, thighs, upper arms, or side of upper leg/hip
  • SC needles are smaller than IV needles. Depending on patient's size and weight, a needle as short as 4mm or as long as 14 mm can be used

Dose

PI

Before switching to HIZENTRA, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.

    Weekly: Start HIZENTRA 1 week after last Immune Globulin Intravenous (Human)

       (IGIV) infusion.

        Initial weekly dose = Previous IGIV dose (in grams) x 1.37

                                  No. of weeks between IGIV doses

    Biweekly (every 2 weeks): Start HIZENTRA 1 or 2 weeks after the last IGIV infusion or

      1 week after the last weekly IGSC infusion. Administer twice the calculated weekly dose.

    Frequent dosing (2 to 7 times per week): Start HIZENTRA 1 week after the last IGIV

      or IGSC infusion. Divide the calculated weekly dose by the desired number of times

      per week.

  • To determine if dose adjustment should be considered, measure the patients serum IgG trough level 2 to 3 months after switching to Hizentra
  • Volume and rate can be adjusted after initial infusion as tolerated, which may decrease infusion time and number of sites
  • Consider changing one variable at a time (eg, rate, volume, ancillary supplies, site) to continue tailoring treatment to your patient

Please see full prescribing information for Hizentra including boxed warning.


Hizentra® is a registered trademark of CSL Behring AG.
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Information obtained from Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, by CSL Behring LLC.

HIZ-0038-MAR21



Please see full prescribing information for Hizentra including boxed warning.

Indications and Important Safety Information


IMPORTANT SAFETY INFORMATION

 

WARNING: Thrombosis may occur with immune globulin products, including Hizentra. 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.

For patients at risk of thrombosis, administer Hizentra 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.


Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.

IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.

Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).

Hizentra is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.

The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results. 

Indications

Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:

  • Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.
  • Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.
    • Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy. 

For subcutaneous infusion only.

Please see full prescribing information for Hizentra including boxed warning. 

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.