ESTABLISHED
Safety Profile1,2
Systemic AEs
IN THE PATH STUDY
Systemic AEs commonly seen with IVIg occurred at a lower rate with Hizentra
Systemic AEs
3.6x lower rate of systemic AEs vs IVIg
Data represent systemic AEs reported during the 13-week, single-arm restabilization phase compared to those reported in the 2 Hizentra groups during the 24-week postrandomized phase. However, this difference should be interpreted with caution, as there was no parallel group of subjects receiving placebo in the IVIg restabilization phase.
TOLERABILITY
Clinically proven tolerability
Most common AEs in the PATH study (experienced by ≥5% of patients; ITT population)
| Placebo (n=57) | 0.2 g/kg Hizentra (n=57) | 0.4 g/kg Hizentra (n=58) | |
|---|---|---|---|
| Local Reactions* | 7.0% | 19.3% | 29.3% |
| Headache | 3.5% | 7.0% | 6.9% |
| Nasopharyngitis | 1.8% | 7.0% | 3.4% |
| Fatigue | 1.8% | 8.8% | 0.0% |
| Upper Respiratory Tract Infection | 3.5% | 5.3% | 3.4% |
| Fall | 0.0% | 5.3% | 1.7% |
| Back Pain | 1.8% | 5.3% | 1.7% |
| Arthralgia | 1.8% | 5.3% | 1.7% |
| Pain in Extremity | 0.0% | 1.8% | 5.2% |
*Includes the following infusion-site reactions: erythema, swelling, pain, induration, warmth, hematoma, and pruritus.
Discontinuations occurred due to local reactions†
(n=87/115) of patients on Hizentra experienced no local reactions1
†One Hizentra patient reported a serious adverse reaction of allergic dermatitis, which led to discontinuation of treatment. One other subject withdrew due to a non-serious adverse reaction (fatigue).
PATH extension study tolerability was similar to the PATH study. The most frequent AEs in the PATH extension study were local infusion site reactions, which occurred more frequently in subjects who received the 0.4 g/kg dose than in subjects who received the 0.2 g/kg dose (18.1% and 9.6%, respectively).
Real-World Data
>16 years of real-world experience in immunology3§
An established safety profile, with consistent safety and tolerability demonstrated across 2 indications, including CIDP4
Consistent safety profile4
Safety data from real-world use is consistent with the safety profile established in controlled clinical trials
- The most frequently reported AEs in clinical practice were injection site reactions, headache, and fatigue
TEE reporting4
The reported rate of TEEs was comparable to the rate reported for the general population
- The estimated overall rate of TEEs was 0.36 per 100 patient years for CIDP and between 0.09 and 0.2 per 100 patient years for the general population
§Hizentra was approved for the treatment of primary immunodeficiencies in 2010 and for CIDP in 2018.3
Abbreviations: AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; ITT, intent-to-treat; IVIg, intravenous immunoglobulin; SCIg, subcutaneous immunoglobulin; TEE, thromboembolic event.
References: 1. van Schaik IN, Bril V, van Geloven N, et al. Lancet Neurol. 2018;17(1):35-46. doi:10.1016/S1474-4422(17)30378-2 2. van Schaik IN, Mielke O, Bril V, et al. Neurol Neuroimmunol Neuroinflamm. 2019;6(5):e590. doi:10.1212/NXI.0000000000000590 3. FDA approves Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CSL Behring. March 16, 2018. Accessed August 6, 2026. https://newsroom.csl.com/2018-03-16-FDA-Approves-Hizentra-R-Immune-Globulin-Subcutaneous-Human-20-Liquid-for-the-Treatment-of-Patients-With-Chronic-Inflammatory-Demyelinating-Polyneuropathy-CIDP 4. Sawyer C, Radu A, Hubsch A, et al. Safety of decade-plus use of IgPro20 in the real world: post-marketing pharmacovigilance report. Poster presented at: Immunoglobulin National Society National Conference; October 17-20, 2024; Washington, DC. 5. Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. Eur J Neurol. 2021;28(11):3556-3583. doi:10.1111/ene.14959
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.