Tag. Fort-building. Skipping. CUVITRU^® is for kids too.

CUVITRU is approved for use as replacement therapy for PI in pediatric patients ≥2 years.

Get a better understanding of how CUVITRU can help treat your child with PI.

CUVITRU [Immune Globulin Subcutaneous (Human)] 20% is approved for the treatment of PI in people 2 years and older. When your child is diagnosed with PI, there are questions, worries, and uncertainties. Understanding your child’s PI and managing it with treatment that can be tailored to meet your child’s individual infusion needs can make a difference.^1,2

Kids in the clinical study had reliable protection from infection and consistent IG levels.¹

In the North American (NA) clinical study of CUVITRU, in both adult and pediatric patients:

Less than 1 serious bacterial infection

On average, people taking CUVITRU experienced 0.012 acute serious bacterial infections (ASBIs), which is significantly less than 1*

Less than 3 serious infections of any kind

The rate of any kind of infection was 2.41

About a day missed of work or school

The amount of time people taking CUVITRU were unable to attend work/school or perform normal daily activities due to illness or infection¹

ASBIs

No ASBIs were experienced by kids taking CUVITRU

In the NA clinical study, no pediatric patients experienced an ASBI*

*One ASBI that occurred during the study was a case of pneumonia in a 78-year-old subject who had specific antibody deficiency.

CUVITRU was studied in 77 adult and pediatric patients with PI >2 years of age in North America. Efficacy—that is, if an immunoglobulin treatment works—was determined in 53 adults aged 16 years or older, 6 adolescents aged 12 to <16 years, and 15 children aged 2 to <12 years. The main goal of the study was to measure how many acute serious bacterial infections (ASBIs) were experienced over the course of 1 year. The FDA standard for efficacy is 1 ASBI per year. ASBIs were evaluated in 74 people taking CUVITRU for an average of 380.5 days (range, 3-629 days).¹

Caregiver Brochure

We’ve created a brochure for caregivers about PI and its treatment with CUVITRU. It’s packed full of helpful information designed to boost your confidence about helping your child with treatment.

Get Caregiver Brochure

With CUVITRU, your child could infuse every 2 weeks.

How can CUVITRU fit into your child’s life?

The length and frequency of infusions will depend on your child’s prescribed dose, the way they respond to treatment, and their individual needs. Their doctor will work with you to customize their administration plan to best suit your family’s lifestyle. Below, you’ll find a few examples of sample treatment plans—so you can get an idea of what others’ treatments are like.*

12-gram/
60-mL dose

Infused every
2 weeks

60 mL/hour/site
in 2 sites

Infusion time
~30 minutes

Sam 14 years, 106 lb

8-gram/
40-mL dose

Infused every
2 weeks

45 mL/hour/site
in 1 site

Infusion time
just under an
hour

Alexie 10 years, 82 lb

3-gram/
15-mL dose

Once-a-week
infusion

30 mL/hour/site
in 1 site

Infusion time
~30 minutes

George 3 years, 31 lb

*Results represent examples of patients' experiences. Individual results may vary. Images depicted are not actual patients.

Doctor Discussion Guide

Talk to your child’s doctor to see if CUVITRU is right for them. We have a Doctor Discussion Guide that you can fill out for your child to answer questions about infusion concerns and preferences that might be a helpful starting place for a conversation.

Check out the Guide

Hadlie Jo has more time for dance practice.

Before CUVITRU, Hadlie Jo was on a weekly treatment that took her 2.5 hours to infuse. With CUVITRU, she infuses for less than an hour every other week*—and that gives her the time to live a more active life.

Read Hadlie Jo’s story

*Results represent an example patient experience. Individual results may vary.

With training, you can give your child their infusion at home.

If you and your child’s doctor decide that CUVITRU is right for them, you’ll receive in-person training for at-home administration, as well as a detailed step-by-step guide. The guide will help you as you learn to administer CUVITRU to your child on your own. It may feel unfamiliar at first, but you’ll become experienced with practice.

Do not use CUVITRU at home until you get nurse training on how to infuse.

The infusion process is broken down into 4 sections.

Our goal is that you feel confident in your ability to complete your child’s infusion in the comfort of your home.

Get organized

Prep and draw
CUVITRU

Start infusion

Remove needle(s)
and wrap up

Turn infusion time into a positive.

Keeping disruptions to a minimum is very important during infusions. To establish infusion time as a routine and reduce potential stress, create an “infusion zone” that helps your child feel more comfortable during infusions. You can set up your child’s infusion zone however you wish, but here are some suggestions:

Consider using sensory distraction techniques

Some examples include a buzzing toy or a smooth rock that the child can paint and keep in the freezer. Your child can hold the sensory toy or cold rock for comfort and to feel involved in their treatment. You can even decorate your own “comfort item” with your child to remind them that you’re there for them during their infusions.

A toy, book, smartphone, or laptop game

These might help your child stay calm, still, and distracted from needles or pain. These simple, everyday objects can help keep your child’s mind occupied and divert their attention from the infusion experience.

If you feel it’s appropriate, involve siblings in the process

They may feel like the child with PI is receiving all the attention, so getting them involved could help avoid hurt feelings.

What are some possible common side effects of CUVITRU?

After their CUVITRU infusion, your child may experience one or more possible side effects. These effects generally go away within a few hours and are less likely to occur after their first few infusions.

Local side effects can include:

Mild or moderate pain, redness, and itching

Systemic side effects can include:

Headache, fatigue, vomiting, nausea, and diarrhea

Contact your HCP if any of these side effects bother your child or don’t go away.

It can help to read the stories of real PI patients doing what they love.

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

Read their stories

References

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

2. Data on file. Takeda US Inc. 2015.

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 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.

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.