Hizentra (Human Normal Immunoglobulin)
Subcutaneous immunoglobulin therapy for immunodeficiency and CIDP
Quick Facts About Hizentra
Key Takeaways About Hizentra
- Home-based therapy: After initial training by your healthcare provider, Hizentra can be self-administered at home using a subcutaneous infusion pump or manual syringe technique, offering greater independence and flexibility
- Steady antibody levels: Subcutaneous immunoglobulin provides more stable IgG blood levels compared to intravenous immunoglobulin, with less peak-to-trough fluctuation and generally fewer systemic side effects
- Dual indication: Hizentra is approved both for antibody replacement in primary and secondary immunodeficiency, and for immunomodulatory treatment of CIDP (chronic inflammatory demyelinating polyneuropathy)
- Plasma-derived product: Made from pooled human plasma with rigorous viral inactivation and removal steps, though a minimal residual risk of pathogen transmission cannot be entirely eliminated
- IgA deficiency caution: Patients with IgA deficiency may be at increased risk of severe allergic reactions because Hizentra contains trace amounts of IgA
What Is Hizentra and What Is It Used For?
Hizentra is a subcutaneous immunoglobulin (SCIg) containing human normal immunoglobulin at a concentration of 200 mg/ml. It is used to replace missing antibodies in patients with primary or secondary immunodeficiency, and as an immunomodulatory treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
Hizentra belongs to a class of medicines called human normal immunoglobulins. Immunoglobulins, also known as antibodies, are blood proteins produced by the immune system that play a critical role in defending the body against infections caused by bacteria, viruses, and other pathogens. In healthy individuals, the immune system continuously produces a diverse repertoire of immunoglobulins that circulate in the bloodstream, providing ongoing protection against a wide range of infectious threats.
The active substance in Hizentra is derived from the pooled blood plasma of thousands of healthy donors. Through a sophisticated manufacturing process, immunoglobulin G (IgG) is isolated, concentrated, and purified to produce a solution that mirrors the natural distribution of IgG subclasses found in human blood: approximately 69% IgG1, 26% IgG2, 3% IgG3, and 2% IgG4. This broad spectrum of antibodies provides passive immunity against the infections and pathogens that the donor population has been exposed to and developed immunity against.
Unlike intravenous immunoglobulin (IVIg) products, which must be administered at a hospital or infusion center, Hizentra is specifically formulated for subcutaneous (under the skin) administration. This route of delivery offers several clinical advantages. Subcutaneous infusion produces more stable and consistent IgG blood levels throughout the dosing interval, avoids the high peak levels associated with intravenous administration (which can cause more systemic side effects), and allows patients to administer the treatment themselves at home after appropriate training by their healthcare provider.
Replacement Therapy for Immunodeficiency
Hizentra is used as replacement therapy (substitution therapy) to raise abnormally low immunoglobulin levels to the normal range. This indication applies to both adults and children (aged 0–18 years) in the following situations:
Primary immunodeficiency (PID) refers to inherited conditions in which the immune system is unable to produce adequate quantities or fully functional immunoglobulins. According to the International Union of Immunological Societies (IUIS), there are more than 400 recognized primary immunodeficiency disorders. Conditions treated with Hizentra include:
- Hypogammaglobulinemia: Abnormally low levels of immunoglobulins in the blood, leaving the patient susceptible to recurrent bacterial infections of the respiratory tract, ears, sinuses, and gastrointestinal system
- Agammaglobulinemia: Complete absence of immunoglobulins, such as X-linked agammaglobulinemia (Bruton disease), requiring lifelong immunoglobulin replacement
- Common variable immunodeficiency (CVID): The most common symptomatic primary immunodeficiency, characterized by low immunoglobulin levels, recurrent infections, and inadequate antibody responses to vaccination. CVID affects approximately 1 in 25,000–50,000 people worldwide
- Severe combined immunodeficiency (SCID): A group of rare, life-threatening disorders in which both T cells and B cells are absent or non-functional, requiring urgent immunoglobulin replacement along with definitive treatment such as bone marrow transplantation
- IgG subclass deficiency: Deficiency in one or more IgG subclasses (particularly IgG2 and IgG3) that causes recurrent infections, even when total IgG levels may appear normal
Secondary immunodeficiency (SID) occurs when the immune system is weakened as a consequence of another disease or its treatment. Patients with secondary immunodeficiency who experience severe or recurrent infections due to inadequate immunoglobulin levels may benefit from Hizentra replacement therapy. Common causes of secondary immunodeficiency include hematological malignancies (such as chronic lymphocytic leukemia and multiple myeloma), immunosuppressive medications, prolonged corticosteroid therapy, and certain autoimmune conditions.
Immunomodulatory Treatment for CIDP
Hizentra is also approved for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a progressive autoimmune disorder affecting the peripheral nervous system. In CIDP, the body’s immune system mistakenly attacks the myelin sheath, the protective insulating layer surrounding peripheral nerves, resulting in chronic inflammation that leads to progressive muscle weakness, numbness, tingling, and impaired coordination, primarily in the arms and legs.
The immunomodulatory mechanism of immunoglobulin in CIDP is complex and not fully elucidated, but it is believed to involve multiple pathways: neutralization of pathogenic autoantibodies, modulation of complement activation, regulation of cytokine production, and alteration of immune cell function. By providing a large pool of diverse antibodies, Hizentra helps to rebalance the immune system and protect peripheral nerves from ongoing autoimmune attack. Clinical trials, including the PATH study (Polyneuropathy And Treatment with Hizentra), have demonstrated that subcutaneous immunoglobulin with Hizentra is effective in preventing CIDP relapse and maintaining neurological function.
Hizentra is one of several subcutaneous and intravenous immunoglobulin products available. Other well-known brands include KIOVIG (IVIg), Cuvitru (SCIg 20%), and Cutaquig (SCIg 16.5%). While all contain human normal immunoglobulin, they differ in concentration, excipients, administration route, and approved indications. Your doctor will choose the most appropriate product based on your clinical needs, and switching between products should only be done under medical supervision.
What Should You Know Before Using Hizentra?
Before starting Hizentra, inform your doctor about all medical conditions, particularly IgA deficiency, history of blood clots, cardiovascular disease, and kidney problems. Do not use Hizentra if you are allergic to human immunoglobulins, polysorbate 80, or L-proline, or if you have hyperprolinemia. Never inject Hizentra into a blood vessel.
Hizentra is a well-established treatment with decades of clinical experience supporting its safety profile in immunodeficiency and CIDP. However, like all plasma-derived biological products, it carries specific risks and precautions that patients and healthcare providers must understand before initiating therapy. A thorough medical evaluation, including blood tests and a detailed medical history, is essential before starting treatment.
Contraindications
You must not use Hizentra if:
- Allergy to immunoglobulins: You are allergic (hypersensitive) to human immunoglobulins, polysorbate 80, or L-proline. Tell your doctor before treatment if you have previously had a reaction to any of these substances
- Hyperprolinemia: You have hyperprolinemia, a rare inherited metabolic disorder characterized by elevated levels of the amino acid proline in the blood. Hizentra contains L-proline as a stabilizing excipient
- Intravenous injection: Hizentra must never be injected into a blood vessel (intravenously). It is designed exclusively for subcutaneous administration
Warnings and Precautions
Talk to your doctor or healthcare professional before using Hizentra if any of the following apply to you:
IgA deficiency: You may be allergic (hypersensitive) to immunoglobulin without knowing it. Severe allergic reactions are rare but can occur even if you have previously received human immunoglobulin and tolerated it well. This is more likely if you have insufficient immunoglobulin type A (IgA) in your blood (IgA deficiency). Hizentra contains trace amounts of IgA (no more than 50 micrograms/ml), which may trigger an allergic reaction in IgA-deficient patients who have developed anti-IgA antibodies. In rare cases, such reactions can include sudden drop in blood pressure (hypotension) or anaphylactic shock.
If you experience symptoms such as sudden drop in blood pressure, rapid heartbeat, chest tightness, difficulty breathing, dizziness, or swelling of the face or throat during or after infusion, stop the infusion immediately and seek emergency medical care. Although rare, anaphylaxis can be life-threatening and requires immediate treatment with epinephrine.
Thromboembolic risk: Tell your doctor if you have a history of heart disease, blood vessel disease, blood clots, thick blood (hyperviscosity), or if you have been immobilized for a prolonged period. These factors may increase the risk of developing a blood clot (thromboembolism) after using Hizentra. Also inform your doctor about all medications you are taking, as some medications, particularly those containing the hormone estrogen (such as oral contraceptives), may further increase this risk. Contact your doctor immediately if you experience shortness of breath, chest pain, pain and swelling in a limb, weakness or numbness on one side of the body, or sudden confusion after using Hizentra.
Aseptic meningitis syndrome (AMS): Contact your doctor if you develop severe headache, stiff neck, drowsiness, fever, sensitivity to light, nausea, or vomiting after using Hizentra. These may be signs of aseptic meningitis syndrome, a temporary non-infectious inflammation of the membranes surrounding the brain and spinal cord. Although AMS is rare with subcutaneous immunoglobulin compared to intravenous administration, it has been reported and typically resolves within several days after discontinuing treatment.
Your doctor or nurse will take the following precautions to minimize the risk of complications:
- Ensuring you are not hypersensitive to human normal immunoglobulin by starting the infusion slowly and following recommended infusion rates carefully
- Monitoring you closely during the infusion, especially if you are receiving immunoglobulin for the first time, have switched from a different product, or have had a long interval (more than eight weeks) since your previous infusion
- Observation for at least 20 minutes after the infusion, or longer in the situations described above
Pregnancy and Breastfeeding
Tell your doctor or healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will determine whether you can receive Hizentra during pregnancy or while nursing.
No clinical studies have been conducted with Hizentra specifically in pregnant women. However, immunoglobulin products have been used by pregnant and breastfeeding women for many years, and no harmful effects on pregnancy, fetal development, or the newborn have been observed. Immunoglobulins are naturally present in breast milk and may provide the nursing infant with some protection against certain infections. The European Medicines Agency (EMA) and other regulatory authorities consider immunoglobulin replacement therapy to be compatible with pregnancy when clinically indicated.
Driving and Operating Machinery
Some patients may experience dizziness or nausea during treatment with Hizentra. If this occurs, you should not drive or operate machinery until these effects have resolved. Most patients, however, are able to resume normal activities shortly after their infusion is complete.
Important Information About Excipients
Hizentra contains L-proline as a stabilizer. You must not use Hizentra if you have hyperprolinemia. This medicine also contains less than 1 mmol (23 mg) sodium per vial, meaning it is essentially sodium-free.
Hizentra is manufactured from human blood plasma. When medicines are made from human blood or plasma, specific measures are taken to prevent transmission of infections to patients. These include careful selection and screening of blood and plasma donors, testing of individual donations and plasma pools for signs of viruses and infections, and incorporation of manufacturing steps designed to inactivate or remove viruses. Despite these measures, the risk of transmitting infectious agents cannot be completely eliminated. The measures taken are considered effective against enveloped viruses such as HIV, hepatitis B, and hepatitis C, as well as non-enveloped viruses such as hepatitis A and parvovirus B19. It is strongly recommended that the name and batch number of the product are recorded each time you receive a dose of Hizentra.
Effects on Blood Tests
After receiving Hizentra, the results of certain blood tests (serological tests) may be temporarily affected. The passively transferred antibodies can interfere with some diagnostic assays, potentially leading to false-positive results. Inform your doctor that you are receiving immunoglobulin therapy before having any blood tests performed.
How Does Hizentra Interact with Other Drugs?
Hizentra can impair the effectiveness of live attenuated vaccines such as measles, mumps, rubella, and varicella for up to 3 months (and up to 1 year for measles). Estrogen-containing medications may increase the risk of blood clots. Do not mix other medicines with the contents of a Hizentra vial.
Although Hizentra has relatively few direct drug interactions compared to many conventional medications, certain interactions are clinically significant and must be considered. The most important interactions involve live vaccines and medications that affect blood clotting risk. Always inform your doctor and pharmacist about all medications you are taking, have recently taken, or are planning to take, including over-the-counter medicines, supplements, and herbal remedies.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Live attenuated vaccines (MMR, varicella, yellow fever) | Immunoglobulins may impair vaccine efficacy by neutralizing live vaccine viruses before adequate immune response develops | Wait at least 3 months after Hizentra before receiving live vaccines; up to 1 year for measles vaccination |
| Estrogen-containing medications (oral contraceptives, HRT) | May additively increase the risk of thromboembolic events when combined with immunoglobulin therapy | Inform your doctor; additional monitoring for thrombotic risk may be warranted |
| Anticoagulants (warfarin, heparin) | High-dose immunoglobulin may affect platelet function and coagulation parameters | Monitor coagulation parameters; dose adjustments may be needed |
| Nephrotoxic drugs | Combined use may increase risk of renal impairment, particularly with high-dose immunoglobulin | Monitor kidney function; ensure adequate hydration |
Vaccination Considerations
Inform the vaccinating physician before any vaccination that you are being treated with Hizentra. The passively transferred antibodies in Hizentra can interfere with the immune response to certain live attenuated vaccines by neutralizing the weakened vaccine virus before your body can mount its own immune response. The following guidelines apply:
- Live vaccines (measles, mumps, rubella, varicella, oral polio, yellow fever, rotavirus): Wait at least 3 months after the last Hizentra dose before vaccination. For measles, the impaired response may persist for up to 1 year
- Inactivated vaccines (influenza, pneumococcal, hepatitis A/B, tetanus, diphtheria): Generally can be given at any time, although the antibody response may be somewhat blunted. Your doctor may check post-vaccination antibody levels to confirm adequate protection
- COVID-19 vaccines: mRNA and viral vector vaccines are not live vaccines and can generally be given during immunoglobulin therapy, though monitoring of antibody response may be advisable
Do not mix other medicines with the contents of a Hizentra vial. Hizentra should be administered separately from any other medications or infusion solutions.
What Is the Correct Dosage of Hizentra?
The dosage of Hizentra is individualized based on body weight, clinical response, and IgG trough levels. For replacement therapy, typical monthly doses are approximately 0.2–0.4 g/kg body weight (2–4 ml/kg), administered in divided subcutaneous doses from daily to every two weeks. For CIDP, the weekly maintenance dose is typically 0.2–0.4 g/kg (1–2 ml/kg).
Always use Hizentra exactly as your doctor has instructed. Do not change the dose or dosing interval without consulting your doctor. If you believe you should be receiving Hizentra more or less frequently, speak with your healthcare provider. Your doctor will calculate the appropriate dose based on your body weight, your measured IgG blood levels, your clinical response to treatment, and whether you are transitioning from intravenous immunoglobulin therapy.
Replacement Therapy (Immunodeficiency)
Loading Dose
Your doctor may determine that an initial loading dose is needed, particularly if your IgG levels are very low. For both adults and children, the loading dose is typically 1–2.5 ml/kg body weight (equivalent to 0.2–0.5 g/kg), divided over several days to improve tolerability.
Maintenance Dose
After the loading phase (if required), maintenance doses are given at regular intervals ranging from daily to once every two weeks, aiming for a cumulative monthly dose of approximately 2–4 ml/kg body weight (0.4–0.8 g/kg per month). Your doctor will adjust the dose based on your clinical response, infection frequency, and measured IgG trough levels. The target IgG trough level is generally above 5–6 g/L, though higher levels may be pursued in some patients.
| Patient Group | Loading Dose | Monthly Maintenance | Frequency |
|---|---|---|---|
| Adults | 1–2.5 ml/kg over several days | 2–4 ml/kg | Daily to every 2 weeks |
| Children (0–18 years) | 1–2.5 ml/kg over several days | 2–4 ml/kg | Daily to every 2 weeks |
Immunomodulatory Treatment (CIDP)
CIDP Dosing
For CIDP, your doctor will start Hizentra treatment one week after your last intravenous immunoglobulin infusion. The initial weekly subcutaneous dose is typically 1.0–2.0 ml/kg body weight (0.2–0.4 g/kg per week). Weekly maintenance doses may be divided into smaller, more frequent doses administered throughout the week if preferred. For biweekly dosing, your doctor will double the weekly dose. The dose will be adjusted based on your neurological status and response to treatment.
Administration Method
If you are receiving treatment at home, it will be initiated by a healthcare professional experienced in immunoglobulin therapy and in training patients for home administration. You will receive thorough instruction in:
- Aseptic (sterile) infusion technique to prevent contamination and infection
- How to prepare the infusion, prime the tubing, and insert the subcutaneous needle
- Selection and rotation of appropriate infusion sites (abdomen, thighs, upper arms, lateral hip)
- How to use an infusion pump or the manual syringe push technique
- Maintaining a treatment diary recording the date, batch number, volume infused, infusion rate, number and location of infusion sites
- What actions to take in the event of adverse reactions
Infusion Sites and Technique
Hizentra is injected subcutaneously (under the skin). Suitable infusion sites include the abdomen, thighs, upper arms, and the lateral aspect of the hip. When large doses are required (more than 50 ml), it is recommended to use multiple infusion sites simultaneously. Each infusion site should be at least 5 cm apart from other sites. You may use an unlimited number of simultaneous infusion sites when using a pump-assisted technique. With the manual syringe technique, only one site can be used per syringe.
Infusion Rate
Your doctor will determine the appropriate infusion rate based on your individual tolerance. When using an infusion pump, the recommended initial rate is up to 20 ml/hour per site, gradually increasing to 35 ml/hour per site over the next two infusions if well tolerated, and potentially higher thereafter. For manual syringe push technique, the initial rate is up to 0.5 ml/min per site (30 ml/hour), increasing to up to 2.0 ml/min per site (120 ml/hour) for subsequent infusions if tolerated.
Missed Dose and Overdose
If you think you have missed a dose, contact your doctor as soon as possible to reschedule. Do not double the next dose to make up for a missed one. If you believe you have received too much Hizentra, contact your doctor immediately. Overdose is unlikely with subcutaneous administration because the infusion rate is self-limiting, but excess doses could theoretically increase the risk of adverse effects such as headache, fluid overload, or thromboembolic events.
What Are the Side Effects of Hizentra?
The most common side effects of Hizentra are injection site reactions (redness, swelling, itching, pain), headache, and rash, which affect more than 1 in 10 patients. These local reactions typically decrease over time. Serious but rare side effects include severe allergic reactions, thromboembolic events, and aseptic meningitis syndrome.
Like all medicines, Hizentra can cause side effects, although not everyone experiences them. Most side effects are mild to moderate and tend to improve as the body adjusts to treatment over the first few weeks and months. Local injection site reactions are the most frequently reported side effects with subcutaneous immunoglobulin therapy but generally become less prominent with continued use.
You may reduce the likelihood and severity of side effects by infusing Hizentra slowly, particularly during the first few infusions. If you experience bothersome side effects, your healthcare provider may suggest reducing the infusion rate, dividing the dose across more infusion sites, or adjusting the dosing schedule.
Very Common
Affects more than 1 in 10 patients
- Injection site reactions (redness, swelling, itching, pain, warmth, induration)
- Headache
- Rash
Common
Affects 1 to 10 in 100 patients
- Dizziness
- Migraine
- Elevated blood pressure (hypertension)
- Diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Itching (pruritus)
- Hives (urticaria)
- Musculoskeletal pain
- Joint pain (arthralgia)
- Fever
- Fatigue, including general malaise
- Chest pain
- Influenza-like symptoms
- Pain
Uncommon
Affects 1 to 10 in 1,000 patients
- Hypersensitivity reactions
- Tremor (including psychomotor hyperactivity)
- Rapid heartbeat (tachycardia)
- Flushing
- Muscle spasms
- Muscle weakness
- Chills, including low body temperature
- Abnormal blood test results suggesting impaired liver or kidney function
- Injection site ulceration or burning sensation
Rare / Post-Marketing Reports
Rare or frequency not known
- Anaphylaxis (severe allergic reaction with sudden blood pressure drop, shock)
- Thromboembolic events (blood clots in veins or arteries, pulmonary embolism, stroke)
- Aseptic meningitis syndrome (severe headache, stiff neck, fever, sensitivity to light)
Signs of severe allergic reaction (sudden drop in blood pressure, rapid heartbeat, difficulty breathing, facial swelling); signs of blood clot (pain and swelling in a limb, chest pain, sudden shortness of breath, weakness or numbness on one side of the body); or signs of aseptic meningitis (severe headache, stiff neck, drowsiness, fever, light sensitivity, nausea and vomiting). Stop the infusion immediately and seek emergency medical help.
Side effects can occur even if you have previously received human immunoglobulins and tolerated them well. If you notice any side effects not listed here, or if any side effect becomes serious, please inform your doctor or pharmacist. Reporting suspected side effects helps to continuously monitor the benefit-risk balance of the medicine.
How Should You Store Hizentra?
Store Hizentra at or below 25°C (77°F). Do not freeze. Keep vials in the original outer carton to protect from light. Once opened, use immediately. Do not use if the solution is cloudy, contains particles, or has been frozen.
Proper storage of Hizentra is essential to maintain the integrity and effectiveness of the product. As a biological medicine derived from human plasma, Hizentra is sensitive to temperature extremes, light exposure, and contamination. Following storage guidelines carefully ensures that each dose provides the full therapeutic benefit.
- Temperature: Store at or below 25°C (77°F). Hizentra should not be refrigerated, although brief exposure to refrigerator temperatures is unlikely to cause harm. Do not freeze the product under any circumstances, as freezing can damage the immunoglobulin proteins and compromise effectiveness
- Light protection: Keep the vials in the original outer carton to protect from light exposure, which can degrade the protein
- After opening: Once a vial has been opened, the solution must be used immediately. Any unused product remaining in the vial after the infusion should be discarded according to local requirements
- Visual inspection: Before each use, visually inspect the solution. It should be clear to slightly opalescent, and the color may range from pale yellow to light brown. Do not use the solution if it is cloudy, contains particles, or if the vial appears damaged
- Expiration date: Do not use Hizentra after the expiration date stated on the outer carton and vial label (after “EXP”)
- Keep out of reach of children: Store this medicine out of sight and reach of children at all times
Allow the solution to reach room temperature or body temperature before administration, as this can improve comfort during the infusion. Do not use external heat sources (such as a microwave) to warm the product. Do not dispose of medicines in household waste or through the sewage system; consult your pharmacist on proper disposal methods.
What Does Hizentra Contain?
Each milliliter of Hizentra contains 200 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin G (IgG). The IgG subclass distribution is: IgG1 ~69%, IgG2 ~26%, IgG3 ~3%, IgG4 ~2%. It contains trace amounts of IgA (not more than 50 micrograms/ml).
Understanding the composition of Hizentra is important for both patients and healthcare providers. As a plasma-derived biological product, its composition reflects the natural antibody profile of the healthy donor population from which it is manufactured.
Active Substance
The active substance is human normal immunoglobulin. Each milliliter contains 200 mg of total protein, of which at least 98% consists of immunoglobulin G (IgG). The approximate distribution of IgG subclasses mirrors normal human plasma:
- IgG1: approximately 69%
- IgG2: approximately 26%
- IgG3: approximately 3%
- IgG4: approximately 2%
This medicine also contains trace amounts of immunoglobulin A (IgA), with a maximum of 50 micrograms per milliliter. This is clinically relevant for patients with IgA deficiency who may have anti-IgA antibodies (see Warnings and Precautions).
Excipients (Inactive Ingredients)
- L-proline: An amino acid used as a stabilizer to maintain protein integrity during storage. Contraindicated in patients with hyperprolinemia
- Polysorbate 80: A non-ionic surfactant that helps maintain solution stability
- Water for injections: The solvent base for the solution
Available Pack Sizes
Hizentra is available as a clear to slightly opalescent solution, pale yellow to light brown in color, supplied in the following presentations:
- Vials: 5 ml, 10 ml, 20 ml, and 50 ml, available in packs of 1, 10, or 20 vials
- Pre-filled syringes: 5 ml, 10 ml, 20 ml, and 50 ml, available in packs of 1, 10, or 20 syringes
Alcohol swabs, needles, infusion sets, tubing, and other administration equipment are not included in the package and must be obtained separately. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Hizentra
Hizentra is a subcutaneous immunoglobulin (SCIg) therapy containing 200 mg/ml of human normal immunoglobulin (IgG). It is used for replacement therapy in patients with primary immunodeficiency (PID) or secondary immunodeficiency (SID) who have abnormally low antibody levels and suffer from recurrent infections. It is also approved for immunomodulatory treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disorder affecting the peripheral nerves. Hizentra can be self-administered at home after proper training.
The key difference is the route of administration. IVIg is infused directly into a vein at a hospital or clinic, typically every 3–4 weeks, while Hizentra is injected under the skin (subcutaneously) and can be self-administered at home. Subcutaneous immunoglobulin provides more stable and consistent blood IgG levels with less peak-to-trough variation, which generally results in fewer systemic side effects such as headache, fatigue, and nausea. However, local injection site reactions (redness, swelling) are more common with subcutaneous administration.
Yes. After initial supervision and training by an experienced healthcare professional, most patients and caregivers can learn to self-administer Hizentra at home. You will be trained in sterile technique, how to prepare and infuse the medication, selection and rotation of infusion sites, and what to do in case of adverse reactions. Home treatment offers greater flexibility, independence, and quality of life compared to hospital-based intravenous infusions. You can choose to use an infusion pump or the manual syringe push technique.
Mild local reactions at the injection site (redness, swelling, warmth, itching) are very common and usually resolve on their own. You can try slowing the infusion rate or using a cold compress after the infusion. If you experience any signs of a severe allergic reaction (difficulty breathing, rapid heartbeat, facial swelling, sudden dizziness), stop the infusion immediately and seek emergency medical care. Also stop the infusion and contact your doctor if you develop severe headache with stiff neck and fever, as this could indicate aseptic meningitis syndrome.
Live attenuated vaccines (such as measles, mumps, rubella, varicella, and yellow fever) should be delayed for at least 3 months after your last Hizentra dose, as the passively transferred antibodies may neutralize the vaccine virus and reduce effectiveness. For measles, this waiting period may be up to 1 year. Inactivated vaccines (including flu shots, pneumococcal, and COVID-19 mRNA vaccines) can generally be given at any time, though the immune response may be somewhat reduced. Always inform the vaccinating physician that you are receiving immunoglobulin therapy.
Store Hizentra at or below 25°C (77°F) and do not freeze. Keep the vials or pre-filled syringes in the original outer carton to protect from light. Once a vial is opened, the solution must be used immediately. Before each use, check the expiration date and visually inspect the solution — do not use it if it is cloudy, contains visible particles, or has been frozen. Always keep the medicine out of the reach of children.
References and Sources
- European Medicines Agency (EMA). Hizentra – Summary of Product Characteristics. Available at: www.ema.europa.eu/en/medicines/human/EPAR/hizentra
- U.S. Food and Drug Administration (FDA). Hizentra Prescribing Information. CSL Behring LLC.
- van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35–46. doi:10.1016/S1474-4422(17)30378-2
- European Society for Immunodeficiencies (ESID). ESID Guidelines for the Diagnosis and Management of Primary Immunodeficiencies. 2024 update.
- Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2021;26(3):242–268.
- Bonilla FA, Khan DA, Ballas ZK, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2015;136(5):1186–1205. doi:10.1016/j.jaci.2015.04.049
- World Health Organization (WHO). Model List of Essential Medicines – Immunoglobulins. 23rd List (2023).
- Jolles S, Orange JS, Gigeri A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146–160.
- Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1–S46. doi:10.1016/j.jaci.2016.09.023
Editorial Team
Medical Content
iMedic Medical Editorial Team
Specialists in Clinical Immunology, Neurology, and Pharmacology
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iMedic Medical Review Board
Independent expert panel following EMA, FDA, ESID, and EFNS/PNS guidelines
Methodology: All content is based on the official Summary of Product Characteristics (SmPC) approved by the European Medicines Agency, FDA prescribing information, peer-reviewed clinical literature, and international treatment guidelines. Content follows the GRADE evidence framework and is free from commercial influence.