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


Prefilled Syringe Information
7 FILES

Physician Resources
Patient Resources
7 FILES

Patient Resources
Administration
4 FILES

Physician Resources
Referral and Support Services
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Referral and Support Services
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.
    • 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 subcutaneous infusion only.

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.
  • Adjust the dose based on clinical response and serum lgG trough levels.

CIDP

  • Initiate therapy with HIZENTRA 1 week after the last IGIV infusion.
  • Recommended subcutaneous dose is 0.2 g/kg (1 mL/kg) body weight per week.
    • In the clinical study after transitioning from IGIV to HIZENTRA, a dose of 0.4 g/kg (2 mL/kg) body weight per week was also safe and effective to prevent CIDP relapse.
  • If CIDP symptoms worsen, on 0.2 g/kg (1 mL/kg) body weight per week, consider increasing the HIZENTRA dose from 0.2 g/kg to 0.4 g/kg body weight per week. If CIDP symptoms worsen on 0.4 g/kg body weight per week, consider re-initiating therapy with IGIV, while discontinuing HIZENTRA.
  • Monitor patient’s clinical response and adjust duration of therapy based on patient need.

Administration 
• PI: Administer at regular intervals from daily up to every 2 weeks.
• CIDP: Administer weekly.
• Infusion sites – Up to 8 infusion sites are allowed simultaneously, with at least 2 inches between sites.

Administration in PI

Infusion Parameters* 1st Infusion Subsequent Infusions
Volume (mL/site) ≤15 ≤25
Rate (mL/hr/site) ≤15 ≤25

*As tolerated

Administration in CIDP

Infusion Parameters* 1st Infusion Subsequent Infusions
Volume (mL/site) ≤20 ≤50
Rate (mL/hr/site) ≤20 ≤50

*As tolerated

 

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-NOV21

 


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.