Hyqvia
HyQvia is a type of antibody called immunoglobulin G. It's used to treat primary immunodeficiency (PI) in adults and children age 2 years and older. This medication is also used to help with nerve damage in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). HyQvia is given as an injection under the skin using an infusion pump about every month. The dosing is typically adjusted based on your weight and immunoglobulin G levels. Common side effects include reactions at the infusion site and headache.
What is HyQvia?
What is HyQvia used for?
- Primary humoral immunodeficiency or PI (a condition that makes you have trouble fighting infections) in people 2 years and older
- Chronic inflammatory demyelinating polyneuropathy or CIDP (a condition that causes nerve damage) in adults
How HyQvia works
HyQvia contains two components.
- Immunoglobulin G (IgG) — the main component of the medication — is a type of antibody that your immune system makes to help you fight off things that can make you sick (e.g., viruses, bacteria). With PI or CIDP, part of your immune system is either missing or isn't working like it should.
- For PI, problems with the immune system can lead to frequent infections. HyQvia is thought to replace IgG and boost your immune system to help prevent infections.
- For CIDP, a dysfunctional immune system can lead to nerve damage. HyQvia thought to prevent an overly active immune system from attacking your nerves.
- Recombinant human hyaluronidase (HY) is a protein that helps your body absorb the medication better when it's injected under the skin.
Drug facts
Side effects of HyQvia
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:
- Infusion-site reactions (e.g., pain, redness, swelling, itching; 52%)
- Headache (21%)
- Feeling tired (11%)
- Fever (7%)
CIDP:
- Infusion-site reactions (24%)
- Headache (20%)
- Fever (15%)
- Feeling tired (8%)
Less Common Side Effects
- Nausea
- Vomiting
- Itching
- Back pain
- Stomach pain
- Pain in arm or leg
HyQvia serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clots: in the lungs (cough, difficulty breathing, chest pain); in the leg (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
- Lung problems: severe breathing problems, wheezing or rattling while breathing, chest pain, fever
The following HyQvia 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
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever
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 HyQvia
Pros
- Works well to prevent infections in people 2 years and older with PI
- Can give at home after you get trained
- Given every 3 to 4 weeks (after the ramp-up period at the beginning of treatment)
- Possible to store at room temperature for up to 3 months, making it convenient for travel
Cons
- Must be given as an injection under the skin
- Might be hard for some people to administer properly
- Has some potential risks, such as kidney and lung problems
- Available as brand-name only
Pharmacist tips for HyQvia
- Mark on your calendar to get your HyQvia infusions at the clinic or infusion center (or even at home if your provider has trained you and decided to let you do so). Writing down when your infusions are helps make sure you don't miss any doses. Talk with your provider right away if you accidentally miss a dose.
- HyQvia infusions can commonly cause redness or swelling at the infusion site. They're usually mild to moderate in severity. But contact your provider if you have a severe or worsening reaction or if a reaction lasts for more than a few days. Your care team can tell you how to adjust your infusion. Call 911 if you're having difficulty breathing or feel your throat or tongue start to swell up.
- HyQvia can raise your risk of blood clots. Stay well hydrated before each HyQvia infusion to help prevent blood clots. Get medical help right away if you have symptoms of a blood clot, such as swelling, pain, tenderness, difficulty breathing, or chest pain.
- Before you get any vaccines, let your provider or pharmacist know that you're taking HyQvia. This medication can interfere with your response to live vaccines like Varivax (varicella vaccine) and MMR (measles, mumps, and rubella vaccine). Your providers can check to make sure the vaccine is safe for you to get.
How to take HyQvia infusions at home:
- Carefully review the instructions on how to infuse HyQvia infusions using either a peristaltic infusion pump or syringe driver pump. Your provider will determine which infusion pump is right for you. Following instructions carefully can help avoid hurting yourself or accidentally wasting any medication. Let your provider or pharmacist know if you have any questions.
- HyQvia comes as a dual vial unit (one vial of HY and one vial of IgG). The order that you infuse HyQvia is important to help your body absorb the medication. First, infuse HY; then infuse IgG within 10 minutes.
- Store HyQvia vials in the refrigerator for up to 3 years from the date of manufacture written on the carton and vial. Don't freeze the medication because this could damage it. You can also keep the vials at room temperature for up to 3 months during the first 2 years of the manufacturing date. Once the vials are at room temperature, don't place them back in the refrigerator. Keep the vials in the original container away from light.
- When it's time for your dose, take HyQvia out of the refrigerator and let it reach room temperature. This can take up to 1 hour. Don't try to warm up the medication any other way (e.g., microwave, under hot water) because you might damage it.
- Always check to make sure the HY vial is clear and colorless and the IgG vial is clear and colorless or pale yellow before you use it. Don't use the vials if the liquids seem cloudy or have particles or if the vial cap is missing or broken. Contact your or your child's 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). This helps lower the risk of needle-stick injuries. Don't throw them away in your trash can. Visit the FDA's website for more information on how to throw away your sharps container safely.
- After each dose, peel off the removable part of the label on each vial you used; stick it in a journal; and log the date and time of your infusion, the dose, infusion site location, and any infusion-related reactions. This helps keep track of your doses and can be helpful during discussions with your provider at your follow-up appointments.
Common questions about HyQvia
For treating PI, it typically takes about 2 hours to infuse the full HyQvia dose. But how long the infusion takes might depend on your dose and how well you tolerate the infusion. When you first start treatment, you'll typically start at a low dose with a slow infusion rate so your body can get used to the infusions. Then, your provider will gradually raise the dose and rate. This means that your infusions might take longer at first. Your provider will calculate the infusion rate for you and adjust it if you're having infusion reactions or side effects. Speak to your provider so you know what to expect.
Headache is a common side effect of HyQvia. If you have a headache after your infusion, try drinking fluids to make sure you're well-hydrated. Also try to stay away from things like intense light or noise since these can worsen headaches. You can also ask your provider about using over-the-counter headache medications, like acetaminophen (Tylenol) or ibuprofen (Advil). It's best to contact your provider if your headaches don't go away or get better because you might need to be seen for a more serious medical issue.
No, HyQvia doesn't typically cause weight gain. Talk to your provider if you notice significant changes in your weight while you're taking HyQvia. Your provider can examine what's causing any weight gain, such as possible fluid buildup, and provide ways to manage this.
Alcohol doesn't appear to interact with HyQvia and affect how well the medication works. But drinking too much alcohol can weaken your immune system. People with primary immunodeficiency already have a weak immune system and have trouble fighting infections. So drinking alcohol during treatment might not be helpful for your condition. Speak with your provider about your drinking habits and ask your provider if there's a safe amount of alcohol you can drink while you're taking HyQvia.
In a small study of 83 people with PI, there were a total of only two short-term, serious bacterial infections that happened over one year. For comparison, a person with PI who isn't treated with immunoglobulin typically has four or more short-term, serious bacterial infections per year. Additionally, there were no hospitalizations during the study. People taking HyQvia also missed an average of fewer than 4 days from work or school due to an infection over the course of one year.
It's possible to infuse HyQvia at home if your provider says it's okay for you to do so. Your provider will most likely administer the medication when you first start treatment. Depending on how comfortable you are, your provider might train you on how to infuse the medication yourself for future doses. Sometimes, providers might decide it's better for you to get your HyQvia infusions at a clinic or infusion center. Discuss with your provider about whether taking HyQvia at home is an option for you.
Talk with your provider about the risks and benefits of using HyQvia before you start this medication if you're pregnant, thinking of becoming pregnant, or breastfeeding. HyQvia hasn't been well studied in human pregnancy, so it's not completely known whether this medication is safe for mothers and unborn babies during pregnancy. Similarly, there's currently no information on the safety of HyQvia while breastfeeding.
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Risks and warnings for HyQvia
HyQvia 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 | History or risk of heart problems
HyQvia can raise your risk of getting blood clots in various parts of your body. Anyone can get a blood clot during treatment, but having certain factors can put you at higher risk. Symptoms of a blood clot might 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.
Your provider will monitor you closely for blood clot symptoms while you're getting treated with HyQvia. If you're at risk for blood clots, your provider might adjust your dose and infusion rate. Make sure you're well hydrated before using HyQvia to help prevent blood clots from happening.
Serious allergic reactions
Serious allergic reactions to HyQvia are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). Stop the infusion and get medical attention right away if you notice dizziness, nausea, a choking sensation, difficulty breathing, swelling around your eyes, or swelling of the lips or tongue after you use HyQvia.
Swelling of the brain
Although rare, some people who used HyQvia developed swelling or inflammation in the brain (aseptic meningitis). Sometimes, symptoms can start to happen within several hours to 2 days of the infusion. This problem typically goes away within several days after stopping treatment. Contact your provider if you have symptoms of meningitis, including 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
People who've taken human immune globulin products that are injected through the vein have had severe and even fatal kidney problems. The risk might be higher if you have certain factors like older age, diabetes, or taking medications that can cause kidney problems.
To be safe, your provider will order lab tests to check your kidney health before and during treatment with HyQvia. Your provider might stop your treatment with the medication if your kidney health worsens. Contact your provider if you have any signs or symptoms of kidney failure, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Anemia due to breakdown of red blood cells
HyQvia might cause your body to rapidly destroy your red blood cells, which can lead to anemia. Your provider might check your blood cell counts during treatment to make sure your red blood cell count doesn't drop too low. Contact your provider if you have any symptoms of anemia, such as tiredness, dizziness, and weakness.
Spread of local infection
Don't infuse HyQvia in or around an infected area on your thighs or stomach. Doing so can cause the infection to spread to other parts of your body.
Lung problems
People who've taken human immune globulin products that are injected through the vein have developed a condition called transfusion-related acute lung injury (TRALI). This condition happens when fluid backs up in your lungs, and it has typically occurred within 1 to 6 hours after taking the medication. Symptoms include severe breathing problems, chest pain or tightness, a racing heartbeat, and fever. To be safe, let your provider know right away if you have any of these symptoms while you're getting treated with HyQvia. Your provider will examine your lungs and give you appropriate treatment.
Risk of infection
Because HyQvia is made from human blood products, there's a risk that it might contain viruses and other germs 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 germs are killed or removed. To prevent serious infections in the rare case that your doses of HyQvia 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.
HyQvia dosage
Typical dosage for HyQvia
HyQvia is given as an injection under the skin of the stomach or thighs using an infusion pump.
PI:
- Your dose depends on your body weight, the IgG levels in your blood, and whether you were previously using another immune globulin therapy.
- You'll start at a low dose, and then ramp up your dose over the first 7 weeks of treatment. You'll typically infuse the medication once during weeks 1, 2, 4, and 7. Then, you'll infuse HyQvia once every 3 to 4 weeks thereafter.
- Your provider will adjust your dose based on how well HyQvia is working for you and whether you're having side effects. Your dose might also differ if you've been exposed to measles or if you're at risk of measles exposure (e.g., traveling to certain places).
CIDP:
- Your HyQvia dose depends on the dose of your previous intravenous immune globulin (IVIG) therapy.
- Your first dose of HyQvia will be 2 weeks after your last IVIG dose. You'll start HyQvia at a low dose and then ramp up your dose over several weeks of treatment (can take up to 9 weeks). Then, you'll infuse HyQvia once every 3 to 4 weeks thereafter.
- Your provider will adjust your dose based on how well HyQvia is working for you and whether you're having side effects.
HyQvia 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 HyQvia will not be safe for you to take.
- Severe allergy to immunoglobulin G, hyaluronidase, or human albumin
- Immunoglobulin A deficiency with antibodies against IgA and a history of allergic reaction to immune globulin
What are alternatives to HyQvia?
Medical conditions that happen when your immune system is missing components or not working like it should: