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:
• 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.
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).
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.
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:
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.