Frequently Asked Questions

A multicenter, double-blind, randomized, placebo-controlled, parallel-group, phase III 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).⁵

CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline.

The main endpoint was the percentage of subjects who had a CIDP relapse or were withdrawn for any other reason during the subcutaneous treatment period. Both Hizentra doses demonstrated superiority over placebo for the main endpoint (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 and p=0.007, respectively), with no statistically significant difference between the Hizentra-treated groups.⁵

81% and 67% of Hizentra-treated subjects remained CIDP relapse free (0.4 g/kg body weight and 0.2 g/kg body weight, respectively); 44% of placebo subjects remained relapse free for up to 24 weeks.⁵

Initiate therapy 1 week after last IVIg infusion

• Recommended subcutaneous dose is 0.2 g/kg body weight per week*
  • A dose of 0.4 g/kg body weight per week was also safe and effective
• If CIDP symptoms worsen on 0.2 g/kg consider increasing to 0.4 g/kg per week*
• Most patients remained relapse-free on either dosing option, with the 0.4 g/kg dose showing a lower rate of relapse^†‡
  • If CIDP symptoms worsen on the 0.4 g/kg dose, consider reinitiating therapy with IVIg

* Administered in 1 or 2 sessions over 1 or 2 consecutive days. † CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline. ‡ Statistical tests between the two doses were not conducted.

View additional dosing information for Hizentra.
Learn more about the efficacy of Hizentra.

Hizentra has been shown to maintain functional ability across multiple secondary endpoints^5*

• Stable MRC score^† – 0.0 median change from baseline; p=0.0026^‡
• Stable INCAT score^† – 0.0 median change from baseline; p<0.0001^‡
• Stable grip strength^† – -1.7 kPa median change from baseline; p=0.0223^‡

Hizentra also demonstrated better R-ODS scores vs placebo^5§

• 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 for all). ^||

In the PATH Study, the most common adverse reactions (ARs) observed in ≥5% of study subjects receiving Hizentra and at a higher frequency than placebo were local infusion-site reactions*, headache, nasopharyngitis, fatigue, upper respiratory tract infection, fall, back pain, arthralgia, and pain in extremity.⁵

Patients on Hizentra reported a 3.6-fold lower rate of systemic adverse reactions per infusion vs IVIg.^† 93% of 4,225 total Hizentra infusions were free of any reported ARs.⁵

Overall, safety findings in the Open-Label Extension (OLE) study to PATH were consistent with those from the PATH study and the established safety profile for Hizentra.

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.

While IVIg treatment helps control CIDP, challenges may remain for many patients. For example, in some patients, poor venous access can make infusion difficult.¹ Also, systemic adverse reactions such as headache and fever can occur.² Patients also have lifestyle burdens. IV infusions can be costly and constraining³ and traveling to an infusion clinic can be time-consuming and require missing work.³

Consider Hizentra for your patients with CIDP who:

• Experience IV-related systemic ARs
• Have venous access issues
• Require more frequent IV infusions
• Seek, flexibility, freedom, and control

Initiate Hizentra therapy 1 week after the last IVIg infusion, with the recommended subcutaneous dose of 0.2 g/kg (1 mL/kg) body weight (bw) per week.

In the PATH study, both 0.2 g/kg and 0.4 g/kg doses were found to be safe and effective.

Patients should contact their healthcare provider for further instructions and monitor for returning symptoms.

A Hizentra dose can be infused into multiple sites, based on dose and tolerability. The number and location of infusion sites depends on the volume of the total dose. Use up to 8 sites per infusion. Infusion sites should be at least 2 inches apart. Change the actual site of infusion with each administration. New sites should be at least 1 inch from the previous site. Recommended infusion sites include the thighs, upper arms, stomach, and hips.

In the PATH Study, patients successfully infused Hizentra at a median of ~1 hour per infusion session (patients received two infusions per week).^5* Your patient's experience may vary, depending on a number of factors, including infusion rate, infusion volume, number of infusion sites used, type of tubing, and patient tolerability.

For patients with CIDP, the first infusion of Hizentra should not exceed a volume of 20 mL per infusion site. The volume may be increased to 50 mL per site for the subsequent infusions as tolerated.

For the first infusion of Hizentra, the recommended maximum flow rate is 20 mL per hour per site. For subsequent infusions, the flow rate may be increased to a maximum of 50 mL per hour per site as tolerated.

Prefilled syringes may be a compelling option for your CIDP patients since they are simple, convenient, and ready to use. Prefilled syringes may reduce steps and effort during infusion preparation vs. vials, depending on dose. And prefilled syringes may also simplify the set-up and transfer of Hizentra for patients who have difficulty drawing from vials. Prefilled syringes are available in a variety of sizes for added convenience when customizing treatment to patient needs.

Learn more about Hizentra prefilled syringes

Hizentra can be stored at room temperature (up to 77°F [25°C]) for its entire shelf life, up to 30 months. Because Hizentra is stored at room temperature, there is no need to refrigerate. Room-temperature storage enables patients to infuse when they are ready, without waiting to bring the product to room temperature before use.

Hizentra provides proven protection against infection, with over 6 million exposures since 2010.^4* In the US clinical trial,^† the annual rate of serious bacterial infections (SBIs) was 0 per subject year, while the annual rate of any types of infections was 2.76 per subject year. This means that patients did not experience any serious infections (eg, bacterial pneumonia, sepsis, osteomyelitis, visceral abscess). On average, patients had fewer than 3 infections of any type per year.⁶

In the long-term (1.7 years) extension study,^7‡ Hizentra was demonstrated to provide safe, sustained, effective protection from infections. In this study, there were zero reported serious bacterial infections (per subject year, annualized rate), zero treatment-related serious adverse events, and zero subjects who discontinued because of treatment-related adverse events.⁷

In the US clinical study, the most common adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine, and pain.

Local reactions were mostly mild (93.4%) or moderate (6.3%). Because Hizentra is infused under skin, local reactions are common and expected. In a clinical study, local reactions decreased over time, from ~20% following the first infusion to <5% by the end of the study.*

Please see the full Prescribing Information for a complete list of adverse reactions.

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.

When switching from IVIg to weekly dosing of Hizentra, the target serum IgG trough level is projected to be approximately 16% higher than the last trough level during prior IVIg therapy. For biweekly (every 2 weeks) dosing of Hizentra, the trough IgG level is projected to be approximately 10% higher than the last IVIg trough level.^*†

Data from more than 150 unique subjects were analyzed, including a subset of pediatric (over age 2) and geriatric (over age 65) subjects.^* No age-related effects were observed; thus, no specific dose adjustments for biweekly or more frequent dosing are needed for either pediatric or geriatric populations.

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level, regardless of the frequency of administration. To determine if a dose adjustment should be considered, measure the patient's serum IgG trough level 2 to 3 months after switching to Hizentra.

Patients should contact their healthcare provider for further instructions and monitor for symptoms of infection.

A Hizentra dose can be infused into multiple sites, based on dose and tolerability. The number and location of infusion sites depends on the volume of the total dose. As few as 1 site and up to 8 sites can be used in parallel. Infusion sites should be at least 2 inches apart. Change the actual site of infusion with each administration. New sites should be at least 1 inch from previous site. Recommended infusion sites include the thighs, upper arms, stomach, and hips. To see how Hizentra can help fit patient needs and preferences, go to the PI patient profiles.

In the US clinical trial, the median duration of a weekly infusion ranged from 1.6 to 2 hours. Hizentra allows flexible dosing for your patients. The duration of infusions can vary, depending on a number of factors, including dosing schedule, number of infusion sites used, type of tubing, needle gauge, and patient tolerability.

For the first infusion of Hizentra, do not exceed a volume of 15 mL per infusion site. The volume may be increased to 25 mL per site as tolerated.

Learn more about dosing and administration

For the first infusion of Hizentra, the recommended maximum flow rate is 15 mL per hour per site. For subsequent infusions, the flow rate may be increased to a maximum of 25 mL per hour per site as tolerated.

Learn more about dosing and administration

No. The maximum volume per infusion site is the same with any of the dosing regimens and is based on patient tolerability. Depending on several factors, the infusion rate might be the same.

Example based on 10-g dose.To determine your patient's specific dose per his or her dosing regimen, use the PI dosing calculator.

Prefilled syringes may be a more compelling options for PI patients since they are simple, convenient, and ready-to-use. Elimination of vial transfer may reduce steps and effort, depending on dose. Prefilled syringes are transferred to a pump syringe using a syringe-to-syringe transfer device. Prefilled syringes are available in a variety of sizes for added convenience when customizing treatment to patient needs.

Learn more about Hizentra prefilled syringes

Hizentra can be stored at room temperature (up to 77°F [25°C]) for its entire shelf life, up to 30 months. Because Hizentra is stored at room temperature, there is no need to refrigerate. Room-temperature storage enables patients to infuse when they are ready, without waiting to bring the product to room temperature before use.