HIZENTRA PROVIDES CONTINUOUS PROTECTION AGAINST INFECTION1,2
continuous protection
Efficacy demonstrated in multiple clinical studies. Hizentra has over 16 years of real-world use1,3
Long-term efficacy and safety were demonstrated across clinical trials1,3 and a pooled analysis of 7 major studies of patients with PI.2
1-year us pivotal trial
(MITT, n=38)1
NO SBIs*†
(Upper 99% CI limit, 0.132)
Efficacy and safety were evaluated in this 1-year, Phase 3, prospective, open-label, single-arm study.
2.76 any infections1†
(95% CI, 2.235-3.370)
LONG-TERM EXTENSION STUDY (N=21)
0.06 SBIs3*‡
2.38 any infections† | (95% CI, 1.88-2.97)
Long-term efficacy and safety were evaluated in this 1.7-year Phase 3, prospective, open-label, single-arm extension study.
Pooled analysis of 7 studies (N=125)
0.03 SBIs2*§(upper 99% CI limit, 0.064)
3.10 any infections† | (upper 99% CI limit, 3.37)
7 open-label, Phase 3, prospective studies were analyzed: 2 US, 2 European, and 3 Japanese studies.
*SBIs were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.2,3
†Per patient year, annualized rate.1-3
‡During the US extension study, 2 SBIs (bacterial pneumonia) in 2 subjects were reported, giving an annualized rate of 0.06 infections per patient year.3
§Overall, there were 7 SBIs in the combined studies, and the annualized rate of SBIs was 0.03 per patient year.2
Additional outcomes
Achieve additional outcomes that matter
Based on the pivotal US trial:
Hizentra provided CONTINUOUS PROTECTION, and higher troughs were observed2
Mean (SD) of the Median Ig trough levels maintained on Hizentra during the 12-month efficacy period was 1253 (321) mg/dL vs 1010 (257) mg/dL with IVIg at baseline.
Based on a pooled analysis of 7 clinical studies (N=125):
0.95 HOSPITALIZED DAYS per patient per year2
(upper 99% CI limit, 1.10)
- 0.2 and 0.55 hospitalized days per patient per year were observed in the US pivotal (N=38) and OLE (n=21) studies, respectively1-3¶
- 36.78 days of prophylactic antibiotic use per patient per year (upper 99% CI limit, 37.68), compared with 48.5 days per patient per year in the US pivotal study2
¶Due to infection.1
Abbreviations: AEs, adverse events; CI, confidence interval; Ig, immunoglobulin; IVIg, intravenous immunoglobulin; MITT, modified intention-to-treat; OLE, open-label extension; PI, primary immunodeficiency; SBI, serious bacterial infection.
References: 1. Hagan JB, Fasano MB, Spector S, et al. J Clin Immunol. 2010;30(5):734-745. doi:10.1007/s10875-010-9423-4 2. Jolles S, Rojavin MA, Lawo JP, et al. J Clin Immunol. 2018;38(8):864-875. doi:10.1007/s10875-018-0560-5 3 3. Jolles S, Borte M, Nelson RP Jr, et al. Clin Immunol. 2014;150(2):161-169. doi:10.1016/j.clim.2013.10.008 4. Data on File. Available from CSL Behring as DOF HIZ-005.
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.
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® is a registered trademark of CSL Behring AG.
Hizentra Connect℠ is a service mark of CSL Behring LLC.