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.
INDICATIONS AND USAGE
Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:
Please see full prescribing information for Hizentra including boxed warning.
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.
Initial weekly dose = Previous IGIV dose (in grams) x 1.37
No. of weeks between IGIV doses
CIDP
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-OCT23
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:
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.