Woman feeding a child at a table, actor portrayal of family life with steady Ig levels on Hizentra

HIZENTRA PROVIDES Consistent steady-state Ig LEVELS^1,2

Maintaining steady Ig levels with Hizentra

SCIg utilization is increasing among patients with PI.³

SCIg is absorbed more slowly from the subcutaneous tissue into the bloodstream and is given more frequently than IVIg⁴
This reduces fluctuations in Ig level peaks and troughs that occur with monthly IVIg⁴

The benefits of steady Ig levels

For your patients with PI, steadier Ig levels may:

Reduce systemic AEs^1,5
Support lower risk of infection at the end of the infusion cycle^1,6

Provide consistent steady-state Ig levels with Hizentra^1,2

A prospective, single-arm, Phase 3, open-label study (N=18) evaluated the PK equivalence of switching stable patients with PI from IVIg 10% to weekly Hizentra (SCIg 20%). Doses were adjusted individually to establish a systemic serum IgG exposure (AUC) noninferior to previous weekly-equivalent IVIg dose and a clinical dose adjustment coefficient.

Treatment with Hizentra produced a mean trough IgG level that was higher than that obtained with IVIg (14.48 g/L [range, 9.52-26.23] vs 11.27 g/L [range, 7.02-18.10], respectively; n=18 in each group)
From day 12 after infusion until the next infusion, patients on IVIg had lower serum IgG levels compared with patients on Hizentra¹
The geometric mean ratio of steady-state AUCs, standardized to a weekly treatment period, for Hizentra vs IVIg was 1.002 (range, 0.77-1.20; 90% CI, 0.951-1.055; n=18)

PK SUBSTUDY: COMPARISON OF MEAN (+SE) SERUM Ig CONCENTRATIONS WITH IVIg AND HIZENTRA¹*

Mean trough Ig level with Hizentra was higher than that obtained with IVIg (14.48 g/L vs 11.27 g/L; n=18 in each group)¹

^*Figure reproduced from Wasserman et al¹ by permission from Springer. Mean serum IgG concentrations measured at weeks 8 to 16 in the Hizentra study are compared with mean serum IgG concentrations measured before and after infusion 7 for patients with a 4-week schedule in the IVIg (IgPro10) study (data from 24 or 25 patients were available for all data points except day 28, when n=21). Mean weekly Hizentra dose was 202.3 mg/kg; mean weekly-equivalent IVIg dose was 156.1 mg/kg. The Hizentra PK study was a prospective substudy within the Hizentra pivotal clinical study, including 18 patients with PI who were transitioned from IVIg to weekly subcutaneous Hizentra. Dosing was individually adjusted to 153% of prior weekly-equivalent IVIg dose to achieve comparable systemic IgG exposure (AUC). Mean serum Ig concentrations were measured at weeks 8 to 16 of the study.

WHY CHOOSE HIZENTRA (SCIg) vs IVIg?

Does not require venous access

Is associated with fewer systemic adverse reactions⁸

Can be independently self-administered at home^†

Importantly, tailoring treatment experiences to the needs of the individual may improve adherence and lifestyle needs for patients who often rely on long-term or lifelong treatment.^9,10

Explore the Differences Between SCIg and IVIg

^†After adequate training provided by a healthcare provider for self-administration.

HIZENTRA IS DIFFERENT FROM IVIg

Significantly lower volume per infusion vs IVIg

IVIg640 mLEVERY 3-4
WEEKS¹¹

HizentraApproximately 110-146 mLEVERY WEEK

With Hizentra, mean peak serum levels are lower (16.17 vs 25.64 g/L) than those achieved with IVIg while mean trough levels are generally higher (14.48 vs 11.27 g/L).¹

Example of total volume per infusion*^†

	Mode of administration	Dosing and frequency of administration	Medications administered prior to Ig treatment	Duration of infusion	Who can administer	Location of infusion
Hizentra SCIg	Subcutaneous	Every 2 weeks, weekly, or flexible dosing (2-7 times/week)	None required	~1-2 hours for weekly administration^‡§	Patient or caregiver, once trained by a healthcare provider	At home, after training
IVIg	Intravenous	Every 3-4 weeks	Premedications may be given to reduce IVIg-related AEs: fever reducers, antihistamines, nausea medications, anti-inflammatory pain relievers	~2-4 hours^‡§	Healthcare provider	Hospital, infusion center, doctor's office, at home by a nurse

	Hizentra SCIg	IVIg
Mode of administration	Subcutaneous	Intravenous
Dosing and frequency of administration	Every 2 weeks, weekly, or flexible dosing (2-7 times/week)	Every 3-4 weeks
Medications administered prior to Ig treatment	None required	Premedications may be given to reduce IVIg-related AEs: fever reducers, antihistamines, nausea medications, anti-inflammatory pain relievers
Duration of infusion	~1-2 hours for weekly administration^‡§	~2-4 hours^‡§
Who can administer	Patient or caregiver, once trained by a healthcare provider	Healthcare provider
Location of infusion	At home, after training	Hospital, infusion center, doctor's office, at home by a nurse

^*Infusion times may vary based on dose and frequency.

^†Ig dosing is calculated based on the patient's body weight. The total volume calculated in this example is based on a patient weight of 176 lb.

^‡Note: This duration does not include supply preparation or potential travel time for infusion appointments.

^§Infusion time will vary depending on the prescribed dose, body weight, and tolerability of Ig infusions.

Moving from IVIg

Moving to SCIg is an option for most patients with PI, but patient characteristics to prioritize include:

Challenges with the highs and lows of Ig levels with IVIg⁵

Intolerable systemic side effects with IVIg, like headache and nausea⁷

Venous access issues and/or port complications⁵

Challenges managing IVIg infusion appointments⁵

Patient advocates are compensated by CSL Behring LLC for their time and/or expenses.

REAL HIZENTRA EXPERIENCES

See the impact of Hizentra on real patients’ lives.

HIZENTRA CLINICAL DATA

Review the efficacy demonstrated across 7 major studies.

Abbreviations: AE, adverse event; AUC, area under the curve; Ig, immunoglobulin; IVIg, intravenous immunoglobulin; PI, primary immunodeficiency; PK, pharmacokinetic; SCIg, subcutaneous immunoglobulin.

References: 1. Wasserman RL, Melamed I, Nelson RP Jr, et al. Clin Pharmacokinet. 2011;50(6):405-414. doi:10.2165/11587030-000000000-00000 2. Hagan JB, Fasano MB, Spector S, et al. J Clin Immunol. 2010;30(5):734-745. doi:10.1007/s10875-010-9423-4 3. Data on File. Available from CSL Behring as DOF HIZ-021. 4. Jolles S, Borte M, Nelson RP Jr, et al. Clin Immunol. 2014;150(2):161-169. doi:10.1016/j.clim.2013.10.008 5. Berger M. Curr Opin Allergy Clin Immunol. 2011;11(6):532-538. doi:10.1097/ACI.0b013e32834c22da 6. Shrestha P, Karmacharya P, Wang Z, Donato A, Joshi AY. World Allergy Organ J. 2019;12(10):100068. doi:10.1016/j.waojou.2019.100068 7. Rojavin MA, Hubsch A, Lawo JP. J Clin Immunol. 2016;36(3):210-219. doi:10.1007/s10875-016-0243-z 8. Jolles S, Rojavin MA, Lawo JP, et al. J Clin Immunol. 2018;38(8):864-875. doi:10.1007/s10875-018-0560-5 9. Immune Deficiency Foundation. Treatment experiences and preferences of patients with primary immune deficiency diseases: first national survey. June 20, 2003. Accessed July 1, 2026. https://primaryimmune.org/resources/print-material/first-national-survey-2003 10. Kafal AR, Vinh DC, Langelier MJ. Prefilled syringes for immunoglobulin G (IgG) replacement therapy: clinical experience from other disease settings. Expert Opin Drug Deliv. 2018;15(12):1199-1209. doi:10.1080/17425247.2018.1546692 11. Privigen. Prescribing information. CSL Behring, Inc. 2025.

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.

HIZENTRA PROVIDES Consistent steady-state Ig LEVELS1,2