Have questions about CUVITRU® and PI?

We have answers to the most frequently asked questions. Be sure to ask your doctor any additional questions you may have.

About CUVITRU

CUVITRU is a liquid medicine that contains immunoglobulin (Ig) antibodies, which help protect your body against infection.1
CUVITRU is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.1

CUVITRU contains antibodies from human plasma donated by healthy people. These antibodies help your body fight off bacterial and viral infections.1 Get more facts about CUVITRU.

CUVITRU is given under the skin (subcutaneously). It can be infused at rates up to 60 mL per hour, per site (as tolerated), and volumes up to 60 mL/site, allowing for fewer needlesticks and less infusion time.1 Most of the time, infusions under the skin are given at home by self-infusion or by caregivers after receiving training from a healthcare professional. You’ll decide how often you’ll infuse–daily, weekly, or every two weeks–with your doctor. Only use CUVITRU by yourself after you have been instructed by your healthcare provider. Find out more about getting started with CUVITRU.

To administer your CUVITRU treatment, the specialty pharmacy will send you these infusion supplies:

CUVITRU vial(s)Syringe(s)Sterile tip caps
Infusion pumpTransfer devicesSubcutaneous needle set
Alcohol swabsTapeSterile clear bandage(s)
Sharps containerGauzeInfusion log

This is not a complete list of all the supplies you may need. When infusing, please remember to refer to your Detailed Instructions for Administration for Patients in the Information for Patients.

Takeda does not prefer, recommend, or attest to using any specific infusion pump or other ancillary device.

The graphic below is an example of what items you can expect to receive from your specialty pharmacy. Talk to your doctor or specialty pharmacist to ensure you’re receiving the supplies necessary to achieve your intended infusion rate. 

Syringe Driver Pump Desktop
  1.  
  2.  
  3.  
  4.  
Infusion supplies icon.
  1. Syringe driver pump: pushes CUVITRU from the syringe
  2. Flow rate tubing: controls the infusion speed of CUVITRU
  3. Needle set: infuses CUVITRU into the subQ space
  4. Needle gauge: helps achieve the desired infusion rate of CUVITRU*
    *To achieve the maximum infusion rate of 60 mL/hour/site with CUVITRU, you'll need a 24-gauge needle.

Store CUVITRU in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 36 months, or at room temperature, not to exceed 77°F (25°C), for up to 24 months. Do not return CUVITRU to the refrigerator if you take it out to room temperature. Do not freeze. Do not shake. Do not use past the expiration date. Protect from light. You can use the original CUVITRU containers to protect it from light.1

Side effects

CUVITRU can cause the following serious reactions1:

  • Severe allergic reactions causing difficulty in breathing or skin rashes
  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, lungs, or elsewhere in the body
  • Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
  • Dark colored urine, swelling, fatigue, or difficulty breathing

Learn more about possible CUVITRU side effects.

Do not use CUVITRU if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if CUVITRU can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.1

Find out more about possible CUVITRU side effects.

CUVITRU can cause serious side effects. If any of the following problems occur after starting CUVITRU, stop the infusion immediately and contact your doctor or call emergency services (911)1:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem
  • Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot
  • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem
  • Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem
  • Fever over 100°F. This could be a sign of an infection

Learn more about possible CUVITRU side effects.

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours and are less likely after the first few infusions.

  • Mild or moderate pain
  • Redness
  • Itching

The most common side effects with CUVITRU are:

  • Headache
  • Nausea
  • Fatigue
  • Diarrhea
  • Vomiting

These are not all of the possible side effects with CUVITRU. Tell your healthcare provider about any side effect that bothers you or that does not go away, and learn more about possible CUVITRU side effects.

Support FAQs

If you have questions related to PI resources or insurance, you may find the answers here.
Be sure to talk to your doctor if you don’t find what you need.

CUVITRU is covered under many commercial health plans. Ask your provider’s office staff to help explain out-of-pocket costs. Takeda Patient Support offers support to patients prescribed a Takeda Ig and enrolled in the program. We’ll also help you understand what’s covered, what’s not, and what to do next.

If you are enrolled, the Takeda Patient Support Co-Pay Assistance Program can help you save on CUVITRU.*

The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must:

  1. Be prescribed a Takeda treatment for a condition it’s approved by the Food and Drug Administration (FDA) to treat. This is called an “approved indication.” Ask your doctor if you’re not sure.
  2. Have commercial insurance. This includes Health Insurance Marketplace plans.
  3. Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans
  4. Be enrolled in Takeda Patient Support.

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

Not enrolled? You can join Takeda Patient Support in a few simple steps at takedapatientsupport.com/​cuvitru/enroll.

If English is not your preferred language, let us know. We can assist you in a language of your choosing.

*IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-866-861-1750. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Primary immunodeficiency is considered a complex and rare disease, and the treatments are considered specialty drugs. CUVITRU is a specialty drug, and only select specialty pharmacy providers (SPPs) have this medication in stock. So, your doctor’s office will order CUVITRU through an SPP.

Rather than pick up your prescription at a retail pharmacy in your neighborhood, specialty drugs are mailed to your home or your doctor’s office. You may be contacted by the SPP to coordinate the delivery.

Financial questions and concerns

Your costs for CUVITRU will depend on many factors, including your pharmacy provider and your insurance plan. When you’re prescribed CUVITRU, Takeda Patient Support is dedicated to helping you get the answers, resources, and tools you need. Some of the ways we can help include:

  • Enrolling you in the Takeda Patient Support Co-Pay Assistance Program, if you qualify*
  • Offering support by walking you through the insurance process step by step

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

*To be eligible, you must be enrolled in Takeda Patient Support and have commercial insurance. Other terms and conditions apply. Call us for more details at 1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET.

If you are enrolled, the Takeda Patient Support Co-Pay Assistance Program can help you save on CUVITRU.*

The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must:

  1. Be prescribed a Takeda treatment for a condition it’s approved by the Food and Drug Administration (FDA) to treat. This is called an “approved indication.” Ask your doctor if you’re not sure.
  2. Have commercial insurance. This includes Health Insurance Marketplace plans.
  3. Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans
  4. Be enrolled in Takeda Patient Support.

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

Not enrolled? You can join Takeda Patient Support in a few simple steps at takedapatientsupport.com/cuvitru/enroll.

If English is not your preferred language, let us know. We can assist you in a language of your choosing.

*IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-866-861-1750. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Many organizations—GoodRx is an example—have started offering patient assistance programs that help people with no health insurance or who are underinsured afford medications. To learn more about them in detail, search “patient assistance programs” in your browser. Additionally, the following websites intermittently offer co-pay assistance or guidance from time to time:

Insurance

CUVITRU is covered similarly to other treatments of primary immunodeficiency, but coverage may vary by plan. Your infusion provider may be able to help explain out-of-pocket costs. Takeda Patient Support also offers insurance and financial support by walking you through the insurance process step by step. We’ll also help you understand what’s covered, what’s not, and what to do next.

When you’re prescribed a Takeda treatment, our specialists are here for you. They’ll review your coverage and help you understand what financial options may be available. Our specialists can walk you through the insurance process step by step. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier.

NEED ASSISTANCE?

Our support specialists are never more than a tap or a call away—1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET.

Additionally, the Immune Deficiency Foundation has a great handbook on how to handle insurance issues and questions. Search for the IDF Health Insurance Toolkit at their website, primaryimmune.org.

As always, your insurer and your insurance policy can affect coverage for any drugs your doctor prescribes, including treatments that you receive on a regular basis, such as IG. Many insurance companies have a list of prescription medications that they will cover under the benefit plan. This list is called a formulary.

It’s important to know if the drugs you take are on your insurance carrier’s formulary. Check the formulary by visiting your insurance company’s website and see if the drug your doctor prescribes is listed. Also look to see if the list includes the type of drug you receive, as well as the specific brand your doctor recommends. Sometimes insurance formularies will list only some of the brands that are available for a medication.

If your brand of medication is (or is not) on the formulary, it can affect how much money you or your family will have to pay for the drug as out-of-pocket costs or co-pays.

When you’re prescribed CUVITRU, our specialists are here for you. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier. Visit TakedaPatientSupport.com for details.

When it comes to immune globulin (IG) treatment, each brand of IG is considered to be a different treatment, because there are important differences in how each brand of these plasma-derived products is made. As a result, different brands of IG treatment are not considered to be interchangeable (or identical), according to medical experts and the Immune Deficiency Foundation.

Some insurance carriers have begun limiting access to specific brands of IG, but many of these insurers also have exception policies in place that may allow continued access to the IG brand your physician recommends.

When you’re prescribed CUVITRU, our specialists at Takeda Patient Support are here for you. They’ll help you understand what’s covered, what’s not, and what to do next. Because our goal is to help make your journey a little easier. Visit TakedaPatientSupport.com for details.

If your insurance plan has special rules for brand-name drugs, you or your family should make sure your doctor is aware of them. For example, tell your doctor if your prescription for IG needs to be worded in a special way to make sure you get exactly what the doctor wants you to receive. Depending on the state you live in, the doctor may need to write “Dispense as written (DAW),” “Brand necessary,” or other statements on the prescription to ensure that the pharmacy dispenses the exact brand of IG that was prescribed.

The Immune Deficiency Foundation (IDF) has a great handbook on how to handle insurance issues and questions if you need it. You can also download an entire chapter about health insurance from an IDF book. See the Resources page for more information about IDF.

PI FAQs

PI is a term used to describe a group of disorders that cause the immune system to not work correctly, making it harder for your body to fight infections. Learn more here.

Your doctor will test you for PI. Read more about diagnosis.

The American Academy of Allergy, Asthma & Immunology (AAAAI) is a professional organization that has a page on its website where you can search for an immunologist—a type of specialist that treats immune system disorders like PI.

Learn more about primary immunodeficiency and connect with someone who is living with PI or has a loved one with PI. Go to MyIgSource.com or call 1-855-250-5111. You can also read basic information about primary immunodeficiency on this website.

Learn more about primary immunodeficiency and connect with someone who is living with PI or has a loved one with PI. Go to MyIgSource.com or call 1-855-250-5111.

Check out the resources page to learn about organizations that can help.

References

1. CUVITRU. Prescribing Information, Takeda Pharmaceuticals USA Inc.; 2023.

2. Gelfand EF. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6:592-599.