Cuvitru
Cuvitru is an immunoglobulin (also known as antibody) that's used to treat primary immunodeficiency (PI) in adults and children ages 2 years and older. It's given as an injection under the skin using an infusion pump. The infusion takes 2 hours on average, but how long it takes depends on your dose and how well you tolerate the medication. Side effects include headache, nausea, and infusion-related reactions (e.g., redness, itching, pain).
What is Cuvitru?
What is Cuvitru used for?
- Primary immunodeficiency or PI (a condition that makes you have trouble fighting infections)
How Cuvitru works
Cuvitru is a replacement for immunoglobulin G (IgG). IgG is a type of antibody that the immune system naturally makes to help fight off viruses and bacteria to prevent infections. But people with primary immunodeficiency don't have enough IgG that works properly, which raises their risk of infections.
The exact way Cuvitru works isn't completely known. But it's thought to work by boosting your immune system to help prevent infections.
Drug facts
Side effects of Cuvitru
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
- Infusion-site reactions, such as pain, redness, and itching (31%)
- Headache (14%)
- Nausea (12%)
Less Common Side Effects
- Fatigue
- Diarrhea
- Vomiting
Cuvitru 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); near the heart (chest pain, arm or shoulder pain, neck or jaw pain); in the brain (difficulty speaking, numbness on one side of the body, confusion)
- Kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
- Lung problems: severe breathing problems, wheezing or rattling while breathing, chest pain, fever
- Brain inflammation: severe headache, neck stiffness, sensitivity to light, painful eye movements
- Breakdown of red blood cells: tiredness, dizziness, weakness, yellowing of the skin or eyes, dark-colored urine
- Serious allergic reaction: difficulty breathing, tightness in the throat, hives, fast heartbeat, dizziness, lightheadedness, swelling in the face or tongue
The following Cuvitru 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 Cuvitru
Pros
- Helps lower the risk of infections due to PI
- Can used in children as young as 2 years old
- Can give at home after you get trained by a healthcare provider
- Can keep at room temperature for up to 2 years, making it convenient for travel
Cons
- Must give as an injection under the skin with an infusion pump
- Might be difficult for some people to administer properly
- Has a lot of potential risks, such as kidney and lung problems
- Doesn't cure PI
Pharmacist tips for Cuvitru
- Mark your appointments on your calendar to see your provider and get your Cuvitru injections. It's important to see your provider on time so you don't miss any doses and your treatment is monitored properly.
- Cuvitru infusions can cause reactions at the injection site like redness, pain, and itching. These reactions are mostly mild or moderate, and they usually last for a few hours. Injection-site reactions are typically less likely to happen as you continue using the medication.
- Contact your provider if you have severe or worsening reactions at the injection site or if they last for more than a few days. You might need your dose or infusion rate adjusted. Call 911 if you're having difficulty breathing or feel your throat or tongue start to swell up.
- Cuvitru 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.
- Before getting any vaccines, let your provider or pharmacist know that you're taking Gammagard S/D. 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 okay for you to get.
How to use Cuvitru at home:
- Make sure you know how to properly and safely use Cuvitru at home. Let your provider or pharmacist know if you have any questions about injecting the medication.
- Store Cuvitru in the refrigerator for up to 3 years. You can also keep the medication at room temperature for up to 2 years; don't place it back in the refrigerator once it reaches room temperature. Check the expiration date on the vial and make sure you don't use it after this date, no matter how you store the medication.
- Keep the medication in the original container away from light. Don't shake it, freeze it, or mix it with other products. This could damage the medication and affect how well it works for you.
- Inject Cuvitru under the skin of either your stomach, thighs, upper arms, or side of your hip by using your infusion pump. Never inject Cuvitru into the muscle or veins since this can cause serious side effects. Also avoid bony areas, areas where you can clearly see blood vessels or scars, and irritated or infected areas.
- You can use up to 4 injection sites at the same time to inject your Cuvitru dose. Make sure they're at least 4 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 area(s) you used last time.
- How to inject Cuvitru: Wipe the area of skin with an alcohol pad to clean it and allow it to dry completely. Then, firmly pinch at least 1 inch of skin between two fingers. Insert the needle into the skin at a 90-degree angle. Tape the needle with sterile tape so it doesn't move. Repeat this process if you're using more than 1 injection site. Then, start the infusion pump according to the manufacturer's instructions.
- After the infusion is complete, throw away used syringes and needles in a sharps container to 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.
Common questions about Cuvitru
In general, the average infusion time will be about 2 hours. But the infusion time will depend on your dose, your infusion rate (how fast you're getting the medication through the infusion pump), how many infusion sites you're using, and how well you tolerate the infusion. When you first start treatment, you'll typically start at a low dose that's given at a slow infusion rate so that your body can get used to the infusions. Then, your provider will gradually raise the dose and infusion rate as long as your body doesn't react poorly to it. This means that your infusions might take longer at first. Speak to your provider so you know what to expect.
It's possible. Ask your provider about using Cuvitru at home. Your provider will probably administer your doses at the clinic or infusion center when you first start using the medication. Depending on how comfortable you are, your provider might train you on how to give yourself the injections or your provider might decide it's better for you to get your doses at a clinic or infusion center.
Weight gain wasn't a reported side effect from people who took Cuvitru during clinical studies. Some IgG brand-name products contain sugar, which can potentially contribute to weight gain, but Cuvitru doesn't have any sugar in it. IgG products like Cuvitru generally require a lot of fluid per dose. This can cause temporary weight gain due to too much fluid. Contact your provider if you notice sudden weight gain.
Since Cuvitru can cause side effects in different parts of your body that you might not feel, your provider will order some lab tests for you to get before you start this medication and also regularly throughout treatment. Some tests check your kidney and lung health, your blood cell count, and your blood protein and triglyceride (fat) levels. Ask your provider if you have any questions about the lab tests you need to get and your test results.
You can still get most vaccines, including certain forms of the flu shot, while you're taking Cuvitru. But you shouldn't get live vaccines because it's not known whether they work well while you're getting treated with this medication. Some live vaccines include FluMist Quadrivalent (live attenuated influenza vaccine) nasal spray and MMR (measles, mumps and rubella vaccine). Before starting Cuvitru, talk with your provider to make sure you're up to date with all of your recommended vaccines. Once you've started treatment, let your provider know that you're taking Cuvitru before you get any vaccines. Your providers can double check whether the vaccine is safe for you to get.
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Risks and warnings for Cuvitru
Cuvitru 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
Cuvitru 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 raise your risk even more. 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. Symptoms of more serious blood clots include chest pain, difficulty breathing, or weakness on one side of the body. Call 911 if you have any of these symptoms because this is a medical emergency.
Your provider will monitor you closely for symptoms of blood clots while you're getting treated with Cuvitru. If you're at risk for blood clots, your provider might adjust your dose and infusion rate. Make sure you're well-hydrated before each Cuvitru injection to help prevent blood clots from happening.
Serious allergic reactions
Serious allergic reactions to Cuvitru are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). Stop the Cuvitru 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 taking the medication.
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 Cuvitru can cause severe and even fatal kidney problems. Your risk is higher if you have certain factors, like older age, diabetes, or are taking medications that can harm the kidneys. Your provider will order lab tests to check your kidney health before and during treatment with Cuvitru. If your kidney health worsens, your provider might stop your treatment. Tell 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.
Swelling of the brain
Although rare, some people who used Cuvitru developed swelling or inflammation in the brain (aseptic meningitis). Sometimes, symptoms can start within several hours to two days after the infusion. It typically goes away within several days after stopping treatment. Call your provider if you have symptoms of meningitis, like severe headache, neck stiffness, sleepiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting.
Anemia due to breakdown of red blood cells
- Risk factors: High doses of Cuvitru | Blood type other than O
Cuvitru can 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 symptoms of anemia, such as tiredness, dizziness, and weakness.
Lung problems
Human immune globulin products like Cuvitru can sometimes cause a condition called transfusion-related acute lung injury (TRALI). This condition happens when fluid backs up in your lungs. Symptoms of the lung problem typically appear within 1 to 6 hours after the infusion. Symptoms include severe breathing problems, chest pain or tightness, a racing heartbeat, and fever. Tell your provider right away if you have any of these symptoms so you can get treated.
Risk of infection
Because Cuvitru is made from human blood products, there's a risk that it might contain viruses or 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 Cuvitru 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.
Cuvitru dosage
Typical dosage for Cuvitru
Cuvitru is typically given as an injection under the skin using an infusion pump. How often you need injections ranges from once per day to once every 2 weeks.
Your dose depends on your body weight, previous dose of immune globulin therapy, and lab results. Your provider will calculate and adjust your dose, your infusion rate, and how often you need infusions based on how well you respond to the medication.
Your provider might also change your dose if you've been exposed to measles and if you're at risk of measles exposure (e.g., traveling to certain places).
Cuvitru 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 Cuvitru will not be safe for you to take.
- Severe allergy to IgG when given as an injection under the skin
- Immunoglobulin A deficiency with antibodies against IgA and a previous allergic reaction to immune globulin
What are alternatives to Cuvitru?
Conditions where your immune system is missing or not working like it should: