Hizentra
Hizentra is an immunoglobulin (also known as antibody) used to treat certain conditions where your immune system is missing or isn't working like it should. It's given as an injection under the skin through an infusion pump and can be given at home. This medication is brand only, and might be expensive.
What is Hizentra?
What is Hizentra used for?
Conditions where your immune system is missing or not working like it should:
- Trouble fighting infections (primary humoral immunodeficiency or PI)
- Damaged nerves (chronic inflammatory demyelinating polyneuropathy or CIDP)
How Hizentra works
Hizentra is a replacement for immunoglobulin G (IgG). IgG is one type of antibody that your immune system makes to help you fight off things that can make you sick, like viruses and bacteria.
But if you have certain medical conditions, your immune system is either missing or isn't working like it should (e.g., too active). This can lead to problems like infections or nerve damage.
The exact way Hizentra works to treat these conditions isn't completely known. But it's thought to work by either boosting your immune system to help prevent infections or preventing an overly active immune system from attacking parts of your body by mistake.
Drug facts
Side effects of Hizentra
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
PI:
- Injection-site reaction (up to 100%)
- Headache (18-25%)
- Diarrhea (up to 10%)
- Fatigue (6-8%)
- Back pain (4-8%)
- Rash (4-8%)
- Nausea (up to 8%)
- Pain in arms or legs (up to 8%)
- Cough (up to 8%)
- Itching (up to 8%)
CIDP:
- Injection-site reaction (19-29%)
- Fatigue (up to 9%)
- Headache (7%)
- Inflammation of nose and throat (3-7%)
Less Common Side Effects
PI:
- Vomiting
- Migraine
- Stomach pain
- Joint pain
- Bruising
- Hives
CIDP:
- Upper respiratory tract infection (e.g., common cold)
- Back or joint pain
- Pain in arms or legs
- Fall
Hizentra serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clot: in the lungs (cough, difficulty breathing, chest pain); in the legs (redness, pain, tenderness, swelling of the skin); near the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw); in the brain (difficulty speaking, numbness on one side of the body, confusion)
- Serious allergic reaction: difficulty breathing, tightness in the throat, hives, fast heartbeat, dizziness, lightheadedness, swelling in the face or tongue
- Brain inflammation: severe headache, neck stiffness, sensitivity to light, painful eye movements
- Kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
- Breakdown of red blood cells: tiredness, dizziness, weakness, yellowing of the skin or eyes, dark-colored urine, high heart rate
- Lung problems: severe breathing problems, chest pain or tightness
The following Hizentra side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
- Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
- Shortness of breath or trouble breathing, cough, unusual weakness or fatigue, blue skin or lips
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Hizentra
Pros
- Can give at home after receiving training
- Injected under the skin (not through the vein like other treatments)
- Can use in children as young as 2 years old for PI
- Available as prefilled syringes, which can make it easier to administer
- Can store at room temperature for up to 2.5 years (30 months), making it convenient for travel
Cons
- Only available as an injection
- Can cause injection-site reactions
- Has a lot of potential risks, such as kidney and lung problems
- Might be difficult for some people to administer as instructed
- Available as brand name only, which can be expensive
Pharmacist tips for Hizentra
- Mark your appointments on your calendar to see your provider and receive Hizentra. It's important to see your provider on time so you don't miss any doses and your treatment is monitored properly.
- Hizentra infusions can commonly cause injection-site reactions like swelling, redness, pain, itching, bruising, scabbing, or irritation. They're usually mild to moderate in severity. But if you experience severe or worsening reactions, or they last for more than a few days, contact your provider. They can tell you how to adjust your infusion. If you're having difficulty breathing or feel your throat or tongue start to swell up, call 911.
- Hizentra can raise your risk of blood clots. Get medical help right away if you experience symptoms of a blood clot, including cough, difficulty breathing, chest pain, headache, trouble speaking, or weakness on one side of your body.
How to give yourself Hizentra at home
- Make sure you know how to give yourself the injections to avoid hurting yourself or accidentally wasting any medication. Let your provider or pharmacist know if you have any questions.
- Download the Hizentra app to set up reminders for your doses and record important information about your infusion (e.g., lot number, expiration date, dose, time, infusion site). You can also peel off the removable part of the label on each syringe or vial you used, stick it in your log book, and write down the date and time of your infusion.
- Hizentra is given as an injection under your skin through an infusion pump into either your stomach, thighs, upper arms, or side of your upper leg or hip. Never inject Hizentra into the muscle or veins since this can cause serious side effects.
- You can use up to 8 injection sites at the same time to inject your Hizentra dose. Make sure they're at least 2 inches apart from each other to avoid skin damage. For your next dose, use different sites that are at least 1 inch away from the sites you used last time.
- Store Hizentra prefilled syringes or vials at room temperature in the original container away from light. Don't shake them because this could damage the medication and affect how well it works for you. Don't freeze or mix Hizentra with other products.
- Always check that the medication is clear and pale yellow to brown before using it. If it's cloudy, discolored, has particles, or the cap of the syringe or vial is missing, don't use it. Contact your provider or pharmacist to see if it's possible to get a replacement.
- Throw away used syringes and needles in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needlestick injuries. Don't throw them away in your trash can. For more information on how to throw away your sharps container safely, visit the FDA's website.
Common questions about Hizentra
Ask your provider if it's okay for you to give yourself Hizentra treatment at home. It's likely that your provider will administer your doses when you first start using the medication. Depending on how comfortable you are, your provider might train you to give yourself the injections, or they might determine it's better for you to receive your doses at a clinic or infusion center.
The total time it takes to infuse Hizentra depends on several factors, including how many infusion sites you're using, the tubing that's used, and how well you're tolerating the medication. In clinical studies, it took about 1.5 to 2 hours to infuse Hizentra for PI and about 1 hour for CIDP.
Yes. Studies showed no differences in safety or how well Hizentra works between people at least 65 years old and younger people. But if you're 65 years or older, you might be at a higher risk for kidney problems and blood clots from this medication. Speak to your provider if you have concerns.
Hizentra hasn't been studied in human pregnancy, so it's not known whether this medication is safe in pregnant females and their unborn baby. Similarly, there's currently no information on the safety of breastfeeding while taking Hizentra. If you're breastfeeding, pregnant, or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Hizentra before starting this medication.
While taking Hizentra, you can still receive certain vaccines, including most forms of the flu shot. But you shouldn't receive live vaccines because it's not known if they work well while you're taking Hizentra. Examples of live vaccines include the FluMist Quadrivalent (live attenuated influenza vaccine) nasal spray or the MMR (measles, mumps, and rubella vaccine) injection. Before starting Hizentra, discuss with your provider to make sure you're up to date with all vaccines. Once you've started treatment, be sure to let your providers know you're taking Hizentra before you receive any vaccines.
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Risks and warnings for Hizentra
Hizentra can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of blood clots
- Risk factors: Older age | Not moving much or on bed rest | History of blood clots | Medical conditions that raise your risk of blood clots | Taking medications that contain estrogen | Central IV lines | Have thick blood | Risk of heart problems
Hizentra can raise your risk of getting blood clots in various parts of your body. While anyone can get a blood clot during treatment, there are certain factors that can put you at higher risk. Symptoms of a blood clot can be different depending on the location of the clot. They can include swelling, warmth, or tenderness in the legs. But more seriously, clots can lead to breathing problems, heart problems, or stroke and cause chest pain; difficulty breathing; or weakness of the face, legs, or arms. Call 911 if you have any of these symptoms, because this is a medical emergency.
Serious allergic reactions
Serious allergic reactions to Hizentra are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). If you notice dizziness, sweating, nausea, a choking sensation, difficulty breathing, swelling around your eyes, or swelling of the lips or tongue after using Hizentra, get medical attention right away.
Swelling (inflammation) of the brain
Although rare, some people treated with Hizentra experienced inflammation of the brain (aseptic meningitis). It can start to happen within several hours to 2 days after receiving Hizentra. Typically, it goes away within several days after stopping treatment. Contact your provider if you experience symptoms of meningitis, such as severe headache, neck stiffness, sleepiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting.
Kidney problems
- Risk factors: Older than 65 years | History of kidney problems | High blood sugar | Sepsis | Having high amounts of certain proteins in blood (paraproteinemia) | Not enough fluids in the body | Taking medications that can cause kidney problems
Human immune globulin products like Hizentra can cause severe, and even fatal, kidney problems. Your risk is higher if you have certain factors like older age, diabetes, or taking medications that can cause kidney problems. Your provider will order lab tests to monitor your kidney health closely before and during treatment with Hizentra. If your kidney health worsens, your provider might stop your Hizentra treatment. Contact your provider if you develop any signs or symptoms of kidney failure, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Breakdown of red blood cells
Hizentra can cause your body to rapidly destroy your red blood cells. Your provider will monitor your blood cell counts during treatment. This makes sure your red blood cell count doesn't drop too low. Contact your provider if you experience symptoms, such as tiredness, dizziness, and weakness.
Lung problems
Human immune globulin products like Hizentra can cause a condition called transfusion-related acute lung injury (TRALI). This condition happens when fluid backs up in your lungs, typically within 1 to 6 hours after receiving the medication. Symptoms include severe breathing problems, chest pain or tightness, a racing heartbeat, and fever. Let your provider know immediately if you experience any of these symptoms so you can get treated.
Infection
Because Hizentra is made from human blood products, there's a risk that it might contain viruses that can make you sick. But your risk of infection is low, since the donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to make sure the viruses are killed or removed. To prevent serious infections in the rare case that your doses of Hizentra are affected, let your provider know right away if you start to feel sick or have symptoms, such as feeling confused and anxious, or having trouble maintaining your balance.
Hizentra dosage
Typical dosage for Hizentra
Hizentra is given as an injection under the skin using an infusion pump.
Your dose depends on things like your body weight, previous dose of immune globulin therapy as an injection into the veins (IV), lab results, and what you’re using Hizentra for. For PI, your dose also depends on whether you're at risk of or exposed to measles (e.g., traveling to certain places).
Your provider will adjust the dose and infusion rate based on how well you respond to the medication.
Hizentra contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Hizentra will not be safe for you to take.
- Severe allergy to human immune globulin
- A genetic condition called hyperprolinemia type I or type II (because Hizentra contains the amino acid L-proline)
- Immunoglobulin A deficiency deficiency with antibodies against IgA and a history of allergic reaction
What are alternatives to Hizentra?
Conditions where your immune system is missing or not working like it should:
Hizentra images
