What is the most important information that I should know about CUVITRU?

CUVITRU can cause the following serious reactions: 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.

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Learn more about CUVITRU^® and infusing from any of the resources below.

Why CUVITRU Brochure

If you’re considering talking to your doctor about CUVITRU, check out this brochure to learn more about CUVITRU and how it may help you. It’s also part of the CUVITRU Consideration Kit. Make sure you ask your doctor for it!

Download

Beginning treatment with CUVITRU is explained in the Patient Starter Kit.

Takeda provides Patient Starter Kits to specialty pharmacies. The kits are designed to help educate patients about infusing CUVITRU and should be sent along with their infusion system. The kit does not replace training by a healthcare provider. The kit includes the following:

Overview Guide (see below)
Step-by-Step Infusion Guide (see below)
Wellness Journal (see below)
Infusion Mat

You can also watch a video to walk you through everything in your kit.

The Overview Guide has all the basics.

What CUVITRU is, what supplies you'll receive, tips for what to do while infusing, and much more can be found here.

Go to the Guide

Get the Step-By-Step Infusion Guide.

The guide outlines the steps. Keep this guide on hand for a refresher if you need it. Your healthcare team will make sure you’re properly trained on how to infuse your medication.

Get the Guide

Wellness Journal

Keep this handy during infusions to record details of your infusion and jot down notes for yourself, including questions or concerns to ask your doctor about.

Download

Get to Know Health Insurance Plans guide.

Stay informed about your health plan options

Information and considerations to help you select the best health plan option for you and to help navigate your treatment journey.

Download

You may also want to check out HelloCUVITRU to learn about the CUVITRU Free Trial Program.

And, at MyIgSource.com, you can learn about a whole community committed to helping patients with PI and their caregivers.

Sources worth looking into

Whether you’re interested in research or connecting with others living with PI, these sources have insights to share.*

Immune Deficiency Foundation

Founded in 1980, IDF is a national non-profit organization dedicated to improving the diagnosis, treatment, and quality of life of people with PI.

If you want to connect with other people living with PI, check out IDF’s discussion boards.

IDF also has a great handbook on how to handle insurance issues and questions if you need it.

You can even download an entire chapter about health insurance from an IDF book.

IDF has local events and holds a national conference every other year in June. In the off years, they hold family retreat weekends. IDF is available to help in many ways, so you may want to register on their website.

Jeffrey Modell Foundation

A global patient organization devoted to early and precise diagnosis, meaningful treatments, and, ultimately, cures through research, education, support, and advocacy.

You can find JMF on a number of social media sites, such as Facebook, YouTube, Instagram, and Flickr, where people living with PI can support each other. You can find the links at jmfworld.com.

In 2004, JMF created the first-ever public service advertising campaign for primary immunodeficiency to coincide with their focus on public awareness and physician education. Since then, they have continued to expand the reach of the campaign to help bring knowledge to members of the PI community and the public. To learn more, please visit www.info4pi.org/wjmf/psa-campaign.

World PI Week

World PI Week aims to raise awareness and diagnosis of PI on a global level. On their website, you can learn all about PI and the events that occur all across the world during World PI Week. World PI Week was founded by a variety of organizations, including the Immune Deficiency Foundation and Jeffrey Modell Foundation.

American Academy of Allergy, Asthma & Immunology (AAAAI)

AAAAI is a professional organization that has tools for the public, including a search page that can help you find an immunologist.

*These organizations are third-party resources and not associated with Takeda.

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IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots

What is CUVITRU?

CUVITRU is a ready-to-use liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about CUVITRU?

CUVITRU can cause the following serious reactions:

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

Who should not use CUVITRU?

Do not use CUVITRU if you:

Have had a severe allergic reaction to immune globulin or other blood products.
Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking CUVITRU?

CUVITRU can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take CUVITRU.
Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of CUVITRU?

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

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 or 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 sign of an infection.

The following one or more possible side effects 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 that may occur are:

Headache
Nausea
Fatigue
Diarrhea
Vomiting

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

For additional safety information, including Warning about Blood Clots, click for Information For Patients and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is CUVITRU?

CUVITRU is a ready-to-use liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about CUVITRU?

CUVITRU can cause the following serious reactions:

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

Who should not use CUVITRU?

Do not use CUVITRU if you:

Have had a severe allergic reaction to immune globulin or other blood products.
Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking CUVITRU?

CUVITRU can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take CUVITRU.
Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of CUVITRU?

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

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 or 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 sign of an infection.

The following one or more possible side effects 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 that may occur are:

Headache
Nausea
Fatigue
Diarrhea
Vomiting

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

For additional safety information, including Warning about Blood Clots, click for Information For Patients and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

©2025 Takeda Pharmaceuticals U.S.A., Inc., 500 Kendall Street, Cambridge, MA 02142. 1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. Takeda, the Takeda logo, and the Takeda Patient Support logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited. CUVITRU, the CUVITRU logo, and MYIGSOURCE are registered trademarks of Baxalta Incorporated. All other trademarks are the property of their respective owners.

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Join a PI community made just for you called My Life, My Story

Learn more about CUVITRU® and infusing from any of the resources below.

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Join a PI community
made just for you called
My Life, My Story

Learn more about CUVITRU^® and infusing from any of the resources below.