FREQUENTLY ASKED
QUESTIONS
Clinical Data
A multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study evaluated the efficacy, safety, and tolerability of 2 different weekly doses of Hizentra (0.4 g/kg body weight and 0.2 g/kg body weight) vs placebo in 172 adult subjects with CIDP and previously treated with IVIg (PATH study).1
The main objective of the study was to determine the percentage of subjects who experienced a CIDP relapse or who withdrew from the study. A CIDP relapse was defined as a ≥1-point increase in their total adjusted INCAT score compared to their baseline.1
Primary end point: Relapse or withdrawal was significantly reduced vs placebo1
- Relapse or withdrawal rate: 38.6% Hizentra 0.2 g/kg (n=22/57;P=0.007), 32.8% Hizentra 0.4 g/kg (n=19/58;P<0.001) vs 63.2% placebo (n=36/57)
The results of a relapse sensitivity analysis showed that Hizentra was significantly more effective than placebo in preventing relapse1:
- 81% of subjects (n=47/58) on the higher Hizentra dose (0.4 g/kg body weight) remained CIDP relapse free
- 67% of subjects (n=38/57) on the lower Hizentra dose (0.2 g/kg body weight) remained CIDP relapse free
- In contrast, only 44% of subjects on placebo (n=25/57) remained relapse free for up to 24 weeks
These findings demonstrate that Hizentra helps effectively maintain the stability achieved with IVIg, providing a consistent and reliable option for management of CIDP.1
The PATH study, a randomized, placebo-controlled clinical trial, evaluated the ability of Hizentra to maintain functional status across several key measures.
Primary end point: Relapse or withdrawal was significantly reduced vs placebo1
- Relapse or withdrawal rate: 38.6% Hizentra 0.2 g/kg (n=22/57; P=0.007), 32.8% Hizentra 0.4 g/kg (n=19/58; P<0.001) vs 63.2% placebo (n=36/57)
Secondary end point data showed that Hizentra helped patients maintain their functional abilities1:
- Stable MRC score: Patients on Hizentra had a median change of 0.0 from their baseline MRC (Medical Research Council) score*†
- Stable INCAT score: The median change from baseline on the INCAT (Inflammatory Neuropathy Cause and Treatment) score was also 0.0 for Hizentra patients, demonstrating maintained functionality of arms and legs*†
- Maintained grip strength: Hizentra patients showed a stable median change of -1.7 kPa (kilopascal) in grip strength, highlighting the therapy’s role in preserving a key functional ability*†‡
- Stable I-RODS score: The median change from baseline to last postdose observation was -3.0 points for the placebo group, -2.0 points for the 0.2 g/kg Hizentra group, and 0.0 for the 0.4 g/kg Hizentra group (P=0.0002 overall)*†§
Learn more about the PATH study here.
*Statistically significant vs placebo at the last postdose observation.
†Overall P values are based on both Hizentra dosing groups compared to placebo.
‡Grip strength change data shown were for dominant hand.
§The difference between the Hizentra 0.2 g/kg group and the placebo group was not significant.
The MRC sum score was assessed in the following 8 bilateral muscle pairs: shoulder abduction, elbow flexion, wrist extension, index finger abduction, hip flexion, knee extension, foot dorsiflexion, and great toe dorsiflexion. The INCAT score is a 10-point scale that covers the functionality of legs and arms. The I-RODS measures a patient's ability to perform a wide range of activities ranging from easy tasks, like reading a book, eating, and brushing teeth, to more difficult tasks such as standing for extended periods of time or running.
In the PATH study, the most common AEs observed in ≥5% of study subjects receiving Hizentra and occurring at a higher frequency than placebo:
- Local infusion site reactions
- Includes infusion-site erythema, swelling, pain, induration, warmth, hematoma, and pruritus
- Headache
- Nasopharyngitis
- Fatigue
- Upper respiratory tract infection
- Fall
- Back pain
- Arthralgia
- Pain in the extremity
WARNING: Thrombosis (blood clots) may occur with immune globulin products, including Hizentra. Risk factors for thrombosis include advanced age, prolonged immobilization, a history of blood clots, and certain cardiovascular conditions. For patients at risk, it is essential to administer Hizentra at the minimum dose and infusion rate practicable and to ensure they are adequately hydrated before administration.
DOSING & ADMIN
Hizentra should be initiated 1 week after the patient’s last IVIg infusion.
- The recommended starting dose is 0.2 g/kg/week; a dose of 0.4 g/kg/week is also safe and effective
- If a patient’s CIDP symptoms worsen while on the lower dose of 0.2 g/kg, consider increasing the dose to 0.4 g/kg per week. This adjustment helps to reestablish symptom control
- If CIDP symptoms worsen on the 0.4 g/kg dose, reinitiating therapy with an approved IVIg product should be considered
Clinical trial findings on dosing:
The PATH study, a pivotal clinical trial (N=172), demonstrated the effectiveness of both dosing options. While both doses were superior to placebo in preventing CIDP relapse or withdrawal (32.8% for 0.4 g/kg Hizentra and 38.6% for 0.2 g/kg Hizentra compared with 63.2% for placebo, P<0.001 or P=0.007, respectively), the 0.4 g/kg dose showed a numerically lower rate of relapse with no statistically significant difference between the 2 doses.
In an open-label extension of the PATH study, 52% (n=38/73) of patients remained relapse free on the 0.2 g/kg dose, and 90% (n=65/72) of patients remained relapse free on the 0.4 g/kg dose. Most patients who experienced a relapse on the 0.2 g/kg dose who titrated up to the 0.4 g/kg dose (89% [n=31/35]) experienced symptom relief.2
These data highlight that Hizentra provides a proven and effective treatment option for patients with CIDP, with the ability to adjust the dose to manage symptoms and continue to prevent CIDP relapse in patients who are stabilized on IVIg.1,2
View additional dosing information for Hizentra.
Learn more about the PATH study here.
The number and location of infusion sites for Hizentra depend on the total dose and patient comfort.
Here are the key guidelines:
- Number of sites: A Hizentra dose can be infused into multiple sites simultaneously, with a maximum of 8 sites at once, or up to 12 sites consecutively per infusion session. (In the PATH study, patients generally used 4 sites per infusion)
- Location: Recommended infusion sites include the thighs, abdomen, upper arms, and the sides of the upper legs or hips
- Site spacing: Infusion sites should be at least 2 inches apart from each other to prevent localized discomfort and ensure proper absorption
- Rotation: It’s essential to rotate the infusion site with each administration. New sites should be at least 1 inch from a previous site
Recommended infusion volume and rate for Hizentra in CIDP:
The following guidelines on infusion volume* and rate* for Hizentra are based on its established safety and efficacy profile from the pivotal PATH study.
First infusion:
- Volume: The initial infusion volume should not exceed 4 g (20 mL) per infusion site
- Rate: The maximum flow rate for the first infusion should not exceed 4 g (20 mL) per hour per site
Subsequent infusions:
- Volume: For subsequent infusions, the volume may be increased up to 10 g (50 mL) per site, as tolerated by the patient
- Rate: The flow rate can be increased to a maximum of 10 g (50 mL) per hour per site, as tolerated
Following these guidelines, which are consistent with findings from the clinical trial and standard practice, helps ensure that patients can comfortably and effectively self-administer Hizentra as part of their long-term management of CIDP.
Need support? Hizentra Connect℠ can provide you and your patients with additional training resources.
*As tolerated.
The PATH study provided data on the typical infusion time for Hizentra.
- Median infusion time: Approximately 1 hour per infusion session3
- Infusion frequency: The patients in the study received Hizentra weekly
It is important to note that the actual infusion time for your patient may vary. Factors such as the prescribed dose, the number of infusion sites used, the infusion rate, and the patient’s own tolerability can all influence the total time.
Try the dosing calculator to optimize your patients' dosing experience.
The key reasons for this preference are simplicity, convenience, and ease of use.
Benefits of Hizentra prefilled syringes4:
- Ready to use: Prefilled syringes are simple and ready for use
- Fewer steps: The elimination of vial transfer to a pump-compatible syringe may reduce the number of steps and the overall effort required for infusion preparation
- Pump compatibility*: Select prefilled syringe sizes are directly compatible with common infusion pumps.† All sizes can be transferred to a pump-compatible syringe using a syringe-to-syringe transfer device
- 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.
Try the dosing calculator to optimize your patients’ subsequent infusions.
SUPPLY & STORAGE
Room temperature storage: Hizentra should be stored at room temperature (up to 77℉ or 25℃) for its entire shelf life of up to 30 months as indicated by the expiration date printed on the outer carton of the prefilled syringe or vial label.
This key feature means that there is no need to refrigerate the product. Patients can easily store Hizentra at home and infuse it when they are ready, without the need to wait for it to warm up. This convenience is a valuable benefit for patients managing CIDP as a chronic condition.
Hizentra is the first and only Ig available in prefilled syringes.
These are a ready-to-use option that may be particularly beneficial for patients who have difficulty with preparing infusions from vials. They can reduce the number of steps and effort required for setup, simplifying the overall process.
You can help your patients experience the benefits of prefilled syringes.
TRAVEL WITH HIZENTRA
Yes, patients can travel with Hizentra and their self-infusion supplies.
Key travel tips for patients using Hizentra5-7:
- 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
Ig MOA
Watch this video to learn more about immunoglobulin G, commonly referred to as Ig, plus key mechanisms of action that are thought to help inhibit and block the pathogenic effects of CIDP.*
*The mechanism of action of Ig has not been fully elucidated but may include immunomodulatory effects.
PATIENT SUPPORT
Hizentra Connect℠ is a suite of support programs and resources to optimize the patient experience and provide ongoing support through 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. Most people with commercial insurance pay $0 (out of pocket).* The Hizentra Copay Program provides eligible patients with commercial insurance up to $20,000 in copay assistance per calendar year
- 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
- 97% of CIDP patients with commercial insurance are covered.8† 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‡
*Subject to terms and conditions of the Copay Support Program, available here.
†As of July 2025. 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 any time they have questions throughout treatment.
97% of CIDP patients with commercial insurance are covered.8* Reimbursement support involves prior authorizations, appeals, and connection to CSL Behring’s field reimbursement team, who will work with your office.
Hizentra is covered under Medicare Part B for CIDP.9† Get patients started today.
*As of July 2025. Prior authorization or step therapy may be required.
†100% coverage for patients with Medicare Part B and a qualifying Medigap plan after Part B annual deductible is met.
Abbreviations: AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; Ig, immunoglobulin; INCAT, Inflammatory Neuropathy Cause and Treatment; I-RODS, Inflammatory Rasch-built Overall Disability Scale; IVIg, intravenous immunoglobulin, MOA, mechanism of action; MRC, Medical Research Council; PI, primary immunodeficiency; TSA, Transportation Security Administration.
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. Katzberg H, Lewis RA, Harbo T, et al. Eur Neurol Rev. 2019;14(1):44-49. doi:10.17925/NR.2019.14.1.44 4. Kafal AR, Vinh DC, Langelier MJ. Expert Opin Drug Deliv. 2018;15(12):1199-1209. doi:10.1080/17425247.2018.1546692 5. Transportation Security Administration. Travel tips. https://www.tsa.gov/travel/travel-tips. Accessed February 5, 2026. 6. Centers for Disease Control and Prevention. Traveling abroad with medicine. https://wwwnc.cdc.gov/travel/page/travel-abroad-with-medicine. Reviewed August 18, 2022. Accessed February 5, 2026. 7. US Food and Drug Administration. Traveling with prescription medications. https://www.fda.gov/drugs/fda-drug-info-rounds-video/traveling-prescription-medications. Accessed February 5, 2026. 8. Data on File. Available from CSL Behring as DOF HIZ-015. 9. GBS|CIDP Foundation International. Published July 16, 2021. Accessed September 10, 2026. https://www.gbs-cidp.org/2021/07/medicare-b-will-cover-an-immunoglobulin-therapy-for-patients-with-cidp-starting-july-18-2021/
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.