Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 07 May 2018

Indication(s)

Hizentra is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1).

Full Prescribing information

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Advisory information

contraindications
• Anaphylactic or severe systemic reaction to human immune globulin or components of Hizentra, such as polysorbate 80 (4)
• Hyperprolinemia (type I or II) (Hizentra contains the stabilizer L-proline) (4)
• IgA-deficient patients with antibodies against IgA and a history of hypersensitivity (4)
Special warnings and precautions

WARNING:THROMBOSIS
See full prescribing information for complete boxed 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.


• IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions (5.1).
• Thrombosis may occur following treatment with immune globulin products, including Hizentra (5.2).
• Aseptic meningitis syndrome has been reported with IGIV or IGSC treatment (5.3).
• Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure (5.4).
• Monitor for clinical signs and symptoms of hemolysis (5.5).
• Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]) (5.6).
• Hizentra is made from human plasma and may contain infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.7).

Adverse reactions

The most common adverse reactions observed in ≥5% of study subjects were local reactions (i.e., swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, rash, pruritus, vomiting, abdominal pain (upper), migraine, and pain (6).

Usage information

Dosing and administration
For subcutaneous infusion only. Do not inject into a blood vessel.
Administer at regular intervals from daily up to every two weeks (biweekly).

Dosage (2.2)
Before switching to Hizentra, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments.
Weekly: Start Hizentra 1 week after last IGIV infusion
Initial weekly dose = (Previous IGIV dose (in grams) x 1.37) / No. of weeks between IGIV doses

Biweekly: Start Hizentra 1 or 2 weeks after the last IGIV infusion or 1 week after the last weekly Hizentra/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 Hizentra/IGSC infusion. Divide the calculated weekly dose by the desired number of times per week.
Adjust the dose based on clinical response and serum IgG trough levels (see Dose Adjustment).

Administration (2.3)
• Infusion sites – 1 to 4 injection sites simultaneously, with at least 2 inches between sites.
 
Infusion
Parameters*
Infusion Number
1st 2nd to 4th 5th 6th and above
Volume (mL/site) ≤ 15 ≤ 20 ≤ 25
Rate (mL/hr/site) 15 ≤ 25

* As tolerated

Use in special populations
• Pregnancy: No human or animal data. Use only if clearly needed (8.1).
• Pediatric: No specific dose requirements are necessary to achieve the desired serum IgG levels (8.4).

Interactions

The passive transfer of antibodies may interfere with the response to live virus vaccines (7.1), and lead to misinterpretation of the results of serological testing (5.8, 7.2).

More information

Category Value
Authorisation number BLA125350
Orphan designation No
Product NDC 44206-451; 44206-452; 44206-454; 44206-455
Date First Approved 03-10-2011
Marketing authorisation holder CSL Behring AG