How can CUVITRU help you?

Proven protection from infection.1

In the North American study, those taking CUVITRU experienced the following per patient-year*:

Represents an infection icon.

Less than 1

serious bacterial infection

On average, people taking CUVITRU experienced 0.012 ASBIs, which is significantly less than 1†

Represents two infection icons.

Less than 3

infections of any kind

The rate of any kind of infection was 2.41

Hospital icon.

Less than ½ of a day

in the hospital

0.06 is the rate of days spent in the hospital due to infections

Crossed-out building icon depicting no missed school or work.

About 1 day

of missed work or school

The amount of time they weren't able to perform normal daily activities due to illness or infections was 1.16 days

In a clinical trial, CUVITRU [Immune Globulin Subcutaneous (Human)] 20% was studied in 77 people with PI ≥2 years of age in North America. The main goal of the study was to measure how many acute serious bacterial infections (ASBIs) patients had over the course of 1 year. ASBIs are short-term but serious infections that need immediate medical care, like pneumonia. The FDA standard for efficacy—that is, if an immunoglobulin treatment works—is 1 ASBI per year. ASBIs were evaluated in 74 people taking CUVITRU for an average of 380.5 days (range, 30-629 days).

*A patient-year is a patient experience in a clinical trial over the course of 1 year. One patient-year is equal to, for example, the experience of 2 patients for 6 months, or 12 patients for 1 month each.

†One ASBI that occurred during the study was a case of pneumonia in a 78-year-old person.

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The tolerability—including general (systemic) and infusion site (local) side effects—of CUVITRU was demonstrated in a clinical study.1

99.8%

(4,319 of 4,327) of infusions were completed without a reduction, interruption, or discontinuation due to tolerability

  • 0 serious adverse reactions (ARs) related to CUVITRU were reported
  • Of the 278 non-serious ARs (excluding infections), 83% were mild, 16% were moderate, and 1% were severe. The severe ARs were not deemed to be causally related to CUVITRU. The most common general reactions were headache, nausea, fatigue, diarrhea, and vomiting

Infusions were well tolerated.1

There was a low rate of infusion site side effects with CUVITRU, regardless of how fast or how much was infused.1

98.2%

(4,247 of 4,327) of infusions in the clinical study had no side effects at the infusion site, like pain, itching, and redness*

Infusion vials icon.

1.8%

of infusions resulted in a local side effect. These side effects were mild or moderate1

  • 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 infusion site side effects. The most common local ARs reported in ≥5% of patients were pain (20.3%), redness (10.8%), and itching (5.4%)

*Infusion site side effects generally go away within a few hours and are less likely after the first few infusions. After that, you'll be able to increase your rate to 60 mL/hr/site, as tolerated.

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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

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 services1:

  • 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, or 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

Do not use CUVITRU if you1:

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.

What should I avoid while taking CUVITRU?1

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.

See how CUVITRU’s infusion options helped 3 people fit PI treatment into their lives.

Hadlie Jo.
Ambassador Julie.
Ambassador Walter.
Read their stories

Reference

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