Frequently Asked
Questions

Clinical Data

Hizentra provides proven protection against infections for patients with PI. Backed by more than 15 million doses* delivered worldwide in PI, its effectiveness has been demonstrated in multiple clinical studies.1-3

Clinical trial results1:

A key US clinical trial† showed that Hizentra effectively reduced infection rates. The study found:

  • No SBIs‡ per subject year. This means patients did not experience severe infections like bacterial pneumonia or sepsis
  • Fewer than 3 infections of any type per subject per year, on average
  • No treatment-related serious AEs were reported in the trial§

Sustained long-term protection4:

In a long-term extension study, Hizentra continued to provide safe and sustained protection. This research confirmed:

  • An annualized rate of 0.06 SBIs# per subject per year
  • No reported treatment-related serious AEs
  • No subjects discontinued due to treatment-related AEs

Explore all efficacy data here.

*Estimated doses based on grams of Hizentra sold worldwide for PI from 2010 through June 2026.

†A prospective, open-label, single-arm, Phase 3 study evaluated the safety and efficacy of weekly subcutaneous Hizentra in patients with PI previously on monthly IVIg (MITT, n=38). The primary end point, annual rate of SBIs per patient, was 0 (upper 99% Cl 0.132).1

‡SBIs were defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.1,2,4

§Two subjects withdrew from the study due to adverse reactions. One subject experienced a severe infusion-site reaction 1 day after the third weekly infusion, and the other subject experienced moderate myositis.

Long-term efficacy and safety were evaluated in this 1.7-year, Phase 3, prospective, open-label, single-arm extension study.4

#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.4

How Hizentra dosing affects IgG trough levels2:

When adjusting a patient’s Hizentra dosing schedule, their IgG trough levels are expected to change. The effect on these levels depends on how frequently the patient will infuse Hizentra.

Projected trough levels based on dosing2:

When transitioning to Hizentra from an IVIg regimen,* IgG trough levels are expected to increase as follows:

  • Weekly dosing: The projected serum IgG trough level is approximately 16% higher than the last trough level achieved with IVIg therapy
  • Biweekly dosing: The projected trough IgG level is approximately 10% higher than the last trough level from IVIg

Switching to Hizentra maintains higher IgG trough levels and consistent protection against infections.

Changes based on Hizentra dosing frequency2:

  • Switching from weekly to biweekly: The target serum IgG trough level is projected to be approximately 5% lower than the last trough level on weekly therapy
  • Switching from weekly to more frequent: The target serum IgG trough level is projected to be approximately 3% to 4% higher than the last trough level on weekly therapy

These adjustments are based on specific dose factors used when transitioning patients from a weekly schedule. The goal is to maintain effective protection against infection by managing these trough levels appropriately.2

Try the dosing calculator to understand the parameters for personalizing your patients’ infusions.

*The initial weekly Hizentra dose is calculated by converting the monthly IVIg dose into a weekly equivalent dose and increasing it using the dose adjustment factor of 1.37. The biweekly dose is calculated by multiplying the calculated weekly Hizentra dose by 2.

Hizentra AEs:

The following information summarizes the AEs observed in clinical trials and what your patient with PI can expect.

The most common AEs (≥5%) reported in the US clinical study* (N=49) were:

  • Local infusion site reactions: All subjects experienced local infusion site reactions (98% comprised of swelling, redness, warmth, pain, and itching). Mild to moderate site reactions are a common side effect of any subcutaneous therapy
  • Systemic AEs: Other AEs, excluding infections, that occurred during or within 72 hours of infusion were: headache (24.5%), diarrhea (10.2%), fatigue (8.2%), back pain (8.2%), nausea (8.2%), pain in extremity (8.2%), cough (8.2%), vomiting (6.1%), upper abdominal pain (6.1%), migraine (6.1%), and pain (6.1%)1

What your patient can expect:

Most local reactions are mild to moderate in severity. In a clinical study conducted in Europe, the frequency of local reactions decreased over time, from about 20% after the first infusion to less than 5% by the end of the study.† This suggests that as patients continue treatment, they become more accustomed to the infusions, which may lead to fewer reactions.5,6

Explore all safety data here.

*A prospective, open-label, single-arm, Phase 3 study evaluated the safety and efficacy of weekly subcutaneous Hizentra in patients with PI previously on monthly IVIg (MITT, n=38). The primary end point, annual rate of SBIs per patient, was 0 (upper 99% CI 0.132).1

†In a prospective, open-label, single-arm, Phase 3 European study, the safety and efficacy of weekly Hizentra were evaluated for 10 months (3-month wash-in/wash-out period followed by a 7-month efficacy period) in 51 subjects with PI who had been treated previously with IVIg every 3 or 4 weeks or with SCIg weekly.6

DOSING & ADMIN

When treating PI, Hizentra can be dosed biweekly or more frequently in both pediatric (≥2 years old) and geriatric (≥65 years old) patients at the discretion of the healthcare provider.

  • Pediatrics: Hizentra dosing is adjusted to body weight. No pediatric-specific dose requirements are necessary for these regimens. Safety and effectiveness of Hizentra in pediatric patients below the age of 2 have not been established.
  • Geriatric Use: No overall differences in safety or efficacy were observed between these subjects and subjects 18 to 65 years of age.

Learn more about dosing here.

When managing patients with PI, a critical step is monitoring their Ig levels to ensure the treatment is effective. If you are switching a patient to Hizentra, you should measure their serum IgG trough level prior to starting Hizentra and again 2 to 3 months after the switch.

This timing allows you to determine if a dose adjustment is needed to achieve the desired clinical response and a stable serum IgG trough level.

While the dose may need to be adjusted over time, these initial measurements are a key part of the management strategy, regardless of the administration frequency. The goal is to ensure the patient is effectively protected from infections, including SBIs.

For healthcare providers treating PI, determining the number of infusion sites for a Hizentra dose is a common question. The number and location of infusion sites depend on the dose and patient tolerability. In the US clinical trial, most infusions required 4 or fewer infusion sites.

Key infusion guidelines for Hizentra:

  • Maximum sites: Patients can use a maximum of 8 sites simultaneously or up to 12 sites consecutively per infusion
  • Site spacing: Infusion sites should be at least 2 inches apart
  • Site rotation: Change the actual site of infusion with each administration. New sites should be at least 1 inch from the previous site
  • Recommended locations: Infuse Hizentra into recommended sites such as the thighs, upper arms, stomach, and the sides of the upper legs/hips

This multisite approach helps manage the volume of the total dose. Adjusting to patient tolerability can minimize patient discomfort while ensuring effective protection from infections, including SBIs.

Recommended volume of Hizentra per infusion site:

For the first infusion, do not exceed a volume of 3 g/site (15 mL/site). After the initial infusion, the volume per site may be increased to 5 g/site (25 mL/site), as tolerated by the patient. This gradual increase helps ensure patient comfort and proper absorption, which are critical for effectively managing PI and reducing the risk of infections, including SBIs.5,7,8

Explore the dosing calculator to optimize your patients’ infusions by adjusting parameters like number of infusion sites and infusion rates.

In the US clinical trial, the median duration for a weekly infusion ranged from 1.6 to 2 hours.

However, it’s important to note that the infusion duration can be flexible and may vary based on several factors, including:

  • Dosing schedule: Weekly, biweekly, or more frequent administration
  • Infusion sites: The number of sites used (up to 8 may be used simultaneously)
  • Equipment: The type of pump, flow-rate tubing, and needle gauge9-12
  • Patient tolerability: The individual patient’s comfort level

This flexibility allows you to tailor the treatment to each patient’s needs, which is crucial for managing chronic conditions like PI and ensuring effective protection against infections, including SBIs.

Explore the dosing calculator to optimize your patients’ infusions.

The recommended maximum volume per site and maximum infusion rate per site remain the same with any of the dosing regimens and are based on patient tolerability.

While the maximum volume per infusion site per hour does not change, the total infusion volume per site and the number of sites will vary based on the dosing regimen.

Hizentra infusion parameters by dosing schedule:

To determine your patient’s specific dose per his or her dosing regimen, use the dosing calculator.

Maximum volume rates per site:

To determine your maximum volume rates per site for initial and subsequent infusions, see volume rate tables.

The key benefits are simplicity, convenience, and ease of use.

Benefits of Hizentra prefilled syringes:

  • Ready to use: Prefilled syringes are simple and ready for use13
  • Fewer steps: The elimination of vial transfer to a pump-syringe may reduce the number of steps and the overall effort required for infusion preparation13
  • Pump compatibility*: Select prefilled syringe sizes are directly compatible with common infusion pumps.† All sizes can be transferred to a pump syringe using a syringe-to-syringe transfer device10-12
  • Flexible sizing: Prefilled syringes are available in a range of sizes—1 g (5 mL), 2 g (10 mL), 4 g (20 mL), and 10 g (50 mL)—for convenient customization of treatment to fit individual patient needs

*Adapter may be required.

†4 g directly compatible with FreedomEdge® and VersaPump®. 10 g directly compatible with Freedom60® and SCIg60®.4-6 FreedomEdge® and Freedom60® are registered trademarks of KORU Medical Systems, Inc. VersaPump® and SCIg60® are registered trademarks of EMED Technologies Corporation. CSL Behring does not recommend or endorse specific infusion pump brands.10-12

Supply & Storage

Hizentra should be stored at room temperature (up to 77°F [25°C]) for its entire shelf life, which is up to 30 months.14*

This room-temperature storage offers several benefits:

  • No refrigeration required: Hizentra does not need to be refrigerated, simplifying storage at home
  • Immediate use: Patients can infuse when they are ready without having to wait for the product to warm up

*As indicated by the expiration date printed on the outer carton of the prefilled syringe or vial label.

Hizentra is the first and only SCIg available in prefilled syringes.

This supply format is designed to be a convenient option for patients. The prefilled syringes may also simplify the setup, including transfer of Hizentra to a pump-compatible syringe which can be particularly beneficial for those who have difficulty drawing from vials.

This ease of use may help with treatment adherence, which is crucial for effective management of PI and for preventing infections, including SBIs.

TRAVEL WITH HIZENTRA

Yes, patients can travel with Hizentra and their self-infusion supplies.

Key travel tips for patients using Hizentra15-17:

  • Bring enough medication: Ensure patients bring an adequate supply of Hizentra for their entire trip. Consider advising they bring extra days’ worth in case of delays
  • Know the destination: Advise patients to locate nearby hospitals and urgent care centers in advance in case of an emergency
  • Maintain proper storage:
    • Patients should keep Hizentra in the original, labeled packaging
    • Store Hizentra at room temperature (up to 77°F [25°C]) protected from light. It should not be exposed to extreme heat or cold
  • Airline travel:
    • Carry-on only: Patients should always carry their medication(s) on board to prevent loss or damage
    • Airport security: Advise patients to inform TSA officers of medically necessary liquids/medications and associated accessories, such as freezer packs, pumps, needles, and syringes, before screening begins
      • TSA allows larger quantities of medically necessary liquids, gels, and aerosols in carry-on luggage as long as they are declared at the checkpoint for inspection
  • International travel:
    • Many countries have laws, regulations, and guidelines about medications that differ from the United States. Patients should check with the foreign embassy of their destination country to ensure Hizentra is permitted there
    • Patients should ask their doctor for a letter of necessity (preferably translated into the appropriate language, if possible) that describes the medical condition for which they are taking Hizentra
    • Patients should bring a copy of their prescriptions for Hizentra and all of their ancillary infusion supplies

This guidance is to help patients maintain their treatment schedule, ensuring continued protection against infections, including SBIs, while away from home.

See how real patients benefited from Hizentra and the flexibility it provided to do the things they love.

Patient Support

Hizentra Connect℠ is a suite of support programs and resources to optimize the patient experience and provide ongoing support throughout their journey.

Hizentra Connect offerings include:

  • Copay support: The Copay Support Program helps eligible people with commercial insurance by assisting with out-of-pocket expenses for Hizentra.
    • The Copay Support Program provides eligible Hizentra patients with commercial insurance up to $20,000 in copay assistance per calendar year
  • Most people with commercial insurance pay $0 out of pocket*
  • Free trial: To help your patients determine if Hizentra is right for them, they may be eligible for a 1-month supply of medicine, infusion equipment, and nurse training for free
  • Insurance navigation support: Hizentra Connect will assist patients with any insurance questions they may have, so their insurance processes can go as smoothly as possible
    • As of July 2025, Hizentra for treatment of primary immunodeficiency is covered for 98% of US commercially insured patients.18† Reimbursement support involves prior authorizations, appeals, and connection to CSL Behring’s field reimbursement team, who will work with your office
    • The Patient Assistance Program helps qualified uninsured or underinsured patients get the treatment they need
    • The Hizentra Continued Treatment Program can help patients continue to receive treatment if they experience a lapse in third-party private health insurance‡

Explore Hizentra Connect offerings.

*Subject to terms and conditions of the Copay Support Program, available here.

†Prior authorization or step therapy may be required.

‡Enrollment required. Subject to terms and conditions.

Yes, Hizentra Connect offers patients in-home infusion training from nurses.

With in-home nurse support, a trained nurse comes to patients’ homes to make sure they’re comfortable self-infusing.

Patients can continue connecting to nursing support virtually anytime they have questions throughout treatment.

At least 98% of patients with PI who have commercial insurance are covered.18*

Hizentra is covered under Medicare Part B for certain types of PI and CIDP. Get patients started today.

*As of July 2025. Prior authorization or step therapy may be required.

START THE CONVERSATION

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S.H.A.R.E TRAINING

Discover our Hizentra training program or find local clinicians who have completed it.

Abbreviations: AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; Ig, immunoglobulin; IVIg, intravenous immunoglobulin; PI, primary immunodeficiency; SBI, serious bacterial infection; SCIg, subcutaneous immunoglobulin.

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. Data on File. Available from CSL Behring as DOF-HIZ-005. 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;17(6):532-538. doi:10.1097/ACI.0b013e32834c22da 6. Jolles S, Bernatowska E, de Gracia J, et al. Clin Immunol. 2011;141(1):90-102. doi:10.1016/j.clim.2011.06.002 7. Wasserman RL, Melamed I, Nelson RP Jr, et al. Clin Pharmacokinet. 2011;50(6):405-414. doi:10.2165/11587030-000000000-00000 8. 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 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. Freedom60® Infusion System Instructions for Use. KORU Medical Systems. 2023. 11. FreedomEdge® Syringe Infusion System Instructions for Use. KORU Medical Systems. 2023. 12. SCIg60 Infusion System Instructions for Use. EMED Technologies; AS-0010021_2.0. 13. Kafal AR, Vinh DC, Langelier MJ. Expert Opin Drug Deliv. 2018;15(12):1199-1209. doi:10.1080/17425247.2018.1546692 14. Data on File. Available from CSL Behring as DOF HIZ-020. 15. Travel tips. Transportation Security Administration. Accessed July 1, 2026. https://www.tsa.gov/travel/travel-tips 16. Traveling abroad with medicine. Centers for Disease Control and Prevention. Updated August 18, 2022. Accessed July 1, 2026. https://wwwnc.cdc.gov/travel/page/travel-abroad-with-medicine 17. Traveling with prescription medications. Food and Drug Administration. Accessed July 1, 2026. https://www.fda.gov/drugs/fda-drug-info-rounds-video/traveling-prescription-medications 18. Data on File. Available from CSL Behring as DOF HIZ-015.

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.

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