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.

My doctor worked with me to
customize a CUVITRU^®dosing regimen
that worked for me and my lifestyle.”

—Karla

Watch Karla's inspiring story

Results represent four patients’ experiences. Individual results may vary.

Actual patient with PI

With their doctors, each patient created a treatment plan with CUVITRU that’s tailored to their needs.

Karla, actual CUVITRU patient with primary immunodeficiency (PI).

Meet Karla

Wants a flexible infusion schedule at home so she can spend more time with her daughter.

Watch Karla's story

Hadlie Jo, actual CUVITRU patient with primary immunodeficiency (PI).

Meet Hadlie Jo

Likes a treatment
schedule that doesn’t slow
her down.

See her treatment plan

Meet Julie

Wants a therapy with fewer systemic side effects vs IVIG and faster infusions.

Learn about her experience

Meet Walter

Wants a treatment
that offers the
fewest needlesticks.

Read Walter's story

Karla—Loves waking up with the sun, caring for her animals, and most of all, her daughter, Sadie.

My treatment schedule is flexible and it just really allows me to plan things with Sadie.”

Actual patient with PI.

Results represent one patient’s experiences. Individual results may vary. Patients should consult with their physician as needed and discuss any concerns or potential side effects.

Karla doesn’t let PI define her

Karla is a mom to Sadie, a gardener, and lives with PI.

Like many others, it took a while to get her diagnosis. Watch as she gets candid about life
with PI, her treatment journey, and not letting it get in the way of daily life.

Hadlie Jo—Dance team member. Cat lover. Spelling bee winner.

After my mom talked to the doctor, I was switched to CUVITRU. I don’t feel sick as much as I did before I was diagnosed, and now that I’m infusing every 2 weeks, I have more time for dance practice!”

Actual patient with PI.

Results represent one patient’s experiences. Individual results may vary. Patients should consult with their physician as needed and discuss any concerns or potential side effects.

Hadlie Jo’s CUVITRU treatment plan

12-gram dose

Given every
2 weeks

2 sites used

F1200 or
Infuset™ 930 flow
rate tubing

Infused in less
than 1 hour

Learn about infusing and the supplies you’ll get.

Get details

“You want what is going to be a convenient treatment for your child, considering the circumstances.”

— Susie, Hadlie Jo’s mom

Julie—Loves a good spin class. Hosts the best July 4th cookout.

The fact that my CUVITRU infusions only take about 35 minutes means I have more time for me.”

Actual patient with PI.

Results represent one patient’s experiences. Individual results may vary. Patients should consult with their physician as needed and discuss any concerns or potential side effects.

Julie’s CUVITRU treatment plan

14-gram dose

Given every
2 weeks

2 sites used

F2400 or
Infuset™ 1850
flow rate tubing

Infused in
~35 minutes

Learn about infusing and the supplies you’ll get.

Get details

Find safety information here.

This is where you’ll find important safety info, including the warning about blood clots, to consider when starting and monitoring your treatment with CUVITRU.

See safety details

Walter—has played ice hockey since he was 6. Works out every day.

My experience with CUVITRU is just what I expected. My infections have been kept under control, my infusions require just 1 site, and I’ve even been able to reduce my infusion time, which is a huge plus.”

Actual patient with PI.

Results represent one patient’s experiences. Individual results may vary. Patients should consult with their physician as needed and discuss any concerns or potential side effects.

Walter’s CUVITRU treatment plan

12-gram dose

Given once
per week

1 site used

F1200 or
Infuset™ 930
flow rate tubing

Infused in
1 hour

Learn about infusing and the supplies you’ll get.

Get details

Contact a Rep

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.

US-CUV-0860v1.0 06/25

My doctor worked with me to customize a CUVITRU® dosing regimen that worked for me and my lifestyle.”

—Karla

With their doctors, each patient created a treatment plan with CUVITRU that’s tailored to their needs.

Reconnect later?

Thank you for visiting

My doctor worked with me to
customize a CUVITRU^®dosing regimen
that worked for me and my lifestyle.”