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People with PI who infuse CUVITRU^® [Immune Globulin Subcutaneous (Human)] 20% Solution weekly or every other week may be able to experience more of these moments.

See how CUVITRU can help

Proven protection from infection.

CUVITRU is a primary immunodeficiency (PI) treatment that offers protection from infection* and a flexible treatment schedule that can be tailored to fit your lifestyle.¹

Learn how it can protect you

*CUVITRU was studied in 77 people with primary immunodeficiency (PI) ≥2 years of age, with the main goal of measuring how many acute serious bacterial infections (ASBIs) were experienced over the course of 1 year. ASBIs are short-term but serious infections that require immediate medical care. For an immunoglobulin (IG) treatment to be effective, the rate of ASBIs must be <1 per year. On average, people taking CUVITRU experienced 0.012 ASBIs per year, which is significantly less.

There was a low rate of local side effects, regardless of how fast or how much was infused.¹

98.2%

of infusions (4247/4327) in the clinical study had no side effects at the infusion site*

Also known as local side effects and include pain, itching, and redness. The 1.8% of infusions that resulted in a side effect at the infusion site were mild or moderate. Infusion site side effects generally go away within a few hours and are less likely after the first few infusions.¹ CUVITRU can be infused at a volume of up to 60 mL per site and at a rate of up to 60 mL per hour, per site.

A mild side effect causes temporary discomfort that goes away on its own, or with little medical intervention. A moderate side effect causes a slight decline in function that goes away on its own, or with little medical intervention, and has no further consequences. 2 of every 3 people (51 of 74) had no local side effects. The most common local ARs reported in ≥5% of patients were pain (20.3%), erythema (10.8%), and pruritus (5.4%).

What are the rates? What were the infusion times?

Starting infusion rate

10-20

mL/hour/site

You’ll infuse your first 2 infusions at 10 to 20 mL/hour/site. After that, you'll be able to increase your rate to 60 mL/hr/site, as tolerated.¹

Average infusion time

0.95

hours

(range, 0.2-6.4 hours) in a study of 77 people with PI ≥2 years old.¹

CUVITRU was studied in 77 people with primary immunodeficiency (PI) ≥2 years of age, with the main goal of measuring how many acute serious bacterial infections (ASBIs) were experienced over the course of 1 year. ASBIs are short-term but serious infections that require immediate medical care.

Explore tolerability

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 info

Ready to reconnect?

Our Doctor Discussion Guide is an interactive Q&A to help start the conversation with your doctor and find out if CUVITRU administration is right for you.

Get the administration guide

Here for you every step of the way.

We have resources that help you get real, honest, helpful guidance should you ever need it, including co-pay assistance if you’re eligible.^†

Learn more about co-pay assistance

^†At a minimum to be eligible, patients must have commercial insurance. Other terms and conditions apply.

Reference

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

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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 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.