Below are answers to the most frequent questions from prescribers like you, categorized by indication and key topic areas. If your questions are not covered on this page or you need additional information, please let us know. We’ll contact you by your preferred method—email, mail, or phone.
Efficacy and SafetyFlexibility for Patients With PIDosing and AdministrationHow It’s Stored and SuppliedTraveling With HizentraHizentra provides proven protection against infection, with over 14.9 million doses delivered worldwide since 2010.1* In the US clinical trial,2†‡ the annual rate of serious bacterial infections (SBIs) was 0 per subject year,§ while the annual rate of any type 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.2 In the trial, there were zero reported serious adverse reactions.II
In the long-term (1.7 years) extension study,3‡ Hizentra was demonstrated to provide safe, sustained, effective protection from infections. In this study, there were 0.06¶ 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.3
In the US clinical study, the most common adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local infusion-site 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, arthralgia, pain, fall, and nasopharyngitis.
Local reactions were mostly mild (93.4%) or moderate (6.3%). Because Hizentra is infused under the skin, local reactions are common and expected. In a clinical study conducted in Europe, 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.*†
When switching from weekly Hizentra dosing to biweekly dosing, the target trough is projected to be approximately 5% lower than the last trough level on weekly therapy. When switching from weekly dosing to more frequent Hizentra dosing, the target serum IgG trough level is projected to be approximately 3–4% higher than the last trough level on weekly therapy.*
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. Infuse Hizentra into a maximum of 8 sites simultaneously; or up to 12 sites consecutively 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 previous site. Recommended infusion sites include the thighs, upper arms, stomach, and side of upper legs/hips. To learn more about self-administering Hizentra and see a diagram of appropriate infusion sites, go to Administration.
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 pump and tubing, needle gauge, and patient tolerability.
For the first infusion of Hizentra, do not exceed a volume of 3 g per infusion site. The volume may be increased to 5 g per site as tolerated.
For the first infusion of Hizentra, the recommended maximum flow rate is 3 g per hour per site. For subsequent infusions, the flow rate may be increased to a maximum of 5 g per hour per site as tolerated.
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.
| Parameter | Hizentra 20% 5x per week |
Hizentra 20% weekly |
Hizentra 20% biweekly (every 2 weeks) |
|---|---|---|---|
| Infusion Schedule | 5x per week | Weekly | Biweekly (every 2 weeks) |
| Total Volume per Infusion | 2 g | 10 g | 20 g |
| Sites | 1 | 2 | 4 |
| Max vol/site/hr | 5 g | 5 g | 5 g |
| Max vol/site | 2 g | 5 g | 5 g |
| Infusion time (approx.) | 25 minutes | 1 hour | 1 hour |
Prefilled syringes may be a more compelling option for PI patients since they are simple, convenient, and ready-to-use. Elimination of vial transfer may reduce steps and effort. 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 device. Prefilled syringes are available in a wide range of sizes—1 g/5 mL, 2 g/10 mL, 4 g/20 mL, 10 g/50 mL—for added convenience when customizing treatment to fit patient needs.
Watch Dr. Beth Younger, M.A., Ph.D. discuss 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 is the first and only Ig available in prefilled syringes. Prefilled syringes may be a convenient option for some people. Prefilled syringes may also simplify the setup and transfer of Hizentra for those who have difficulty drawing from vials.
You can help your patients experience the benefits of prefilled syringes.
Yes. Patients can take Hizentra and their self-infusion supplies with them when traveling.
Suggestions and tips to communicate to traveling patients include:
