Jump to main content

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.

  • Protection from Infection
  • Safety Information

EFFECTIVENESS AND SAFETY

Proven to help fight infection due to PI.1

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) were experienced over the course of 1 year. 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).

CUVITRU delivers the protection you deserve. In the North American study*, there were 0.012 ASBIs per patient-year† which means:

12 serious infections occurred in 1,000 people

over the course of 1 year

Multiple orange-colored circles.
Red bacteria icon.

Less than 3

infections of any kind

Those taking CUVITRU had infections of any kind at a rate of 2.41 per patient-year.

Blue hospital icon.

About ½
of a day

in the hospital

The rate of days spent in a hospital due to infection was 0.06 for those taking CUVITRU per patient-year.†1

Light blue home icon.

About 1 day

of missed work or school

Those taking CUVITRU had about 1 day in which they weren’t able to perform normal daily activities due to illness or infection.1,2

*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 per year, which is significantly less.

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

Multiple filled orange circles with a half-filled one at the end.

99.8%

of infusions were completed without a reduction, interruption or
discontinuation due to tolerability

In the North American clinical study1,2

  • 0 serious adverse reactions (ARs) related to CUVITRU were reported
  • Of the 278 non-serious ARs (excluding infections), 83% (n=231) were rated as mild, 16% (n=45) were rated as moderate, and 1% (n=2) were rated as severe (hemoptysis and abdominal pain)‡
    • The 2 severe ARs were not deemed to be causally related to CUVITRU
  • The most common systemic ARs observed in greater than or equal to 5% of patients were headache, nausea, fatigue, diarrhea, and vomiting

Well-tolerated administration.1

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

Multiple blue vials with two orange ones at the end.

98.2%

(4247/4327) of infusions in the clinical study* had no side effects
where the medicine is given,§ such as pain, itching, and redness1

1.8%

of infusions resulted in a local
side effect. They 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 local side effects1
  • The most common local ARs reported in ≥5% of patients were pain (20.3%), erythema (10.8%), and pruritus (5.4%)

‡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.

§Infusion site side effects generally go away within a few hours and are less likely after the first few infusions.

The most common side effects of CUVITRU included:

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

Local side effects:

occurred in <1% of infusions given

  • Mild or moderate pain

    Mild or moderate pain

    Some people experienced some pain on their bodies where the infusion was given. Discomfort or pain like this usually goes away within a few hours.

    36 times (0.8%)
  • Redness

    Redness

    Some people noticed that their skin looked red where the injection was given. Again, this usually goes away within a few hours.

    23 times (0.5%)
  • Itching

    Itching

    Itching on the skin near the place where the injection was given was also reported by people taking CUVITRU. The itching was temporary and went away on its own.

    8 times (0.2%)
Blue body icon with multiple orange dots on one arm and one leg.

Systemic side effects:

occurred in <1.3% of infusions given

  • Headache

    Headache

    Like many Ig treatments, headaches have been reported during or after the infusion with CUVITRU.

    50 times (1.2%)
  • Nausea

    Nausea

    Some people felt nauseous or thought they might need to throw up during or after their infusion with CUVITRU.

    16 times (0.4%)
  • Fatigue

    Fatigue

    People have said they feel more tired than usual after infusing CUVITRU and may need to rest.

    9 times (0.2%)
  • Diarrhea

    Diarrhea

    Some people have reported loose, watery stools or a frequent need to have a bowel movement after their infusion.

    5 times (0.1%)
  • Vomiting

    Vomiting

    Some people have vomited (thrown up) during or after the infusion with CUVITRU.

    5 times (0.1%)
  • Local side effects are the ones that occur on the body where the medicine is given. These generally go away within a few hours and are less likely after the first few infusions.
  • Systemic side effects are the ones that happen throughout the body, not just in one part. A headache or feeling more tired than usual are both examples of a systemic side effect.

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 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, 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 you:

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 [Immune Globulin Subcutaneous (Human)] 20%?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.

Two blue bubbles icon.

Your doctor is your best resource for questions about side effects.

Get thought starters
Three CUVITRU® patients from kid age to middle-age, smiling.

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

Read patient stories
  1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
  2. Suez D, Stein M, Gupta S, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700-712.

You are now leaving
CUVITRU.com

By following this link, you will be leaving a Takeda controlled website for a third-party website. Please note that Takeda is not responsible or liable for any third-party website and the website may not be appropriate for all audiences.

Continue Return to CUVITRU.com

For healthcare
professionals only

The information on this website is technical in nature and has been specifically created for US healthcare professionals (HCPs). If you are not an HCP and would like to visit the consumer site, please visit CUVITRU.com.

Continue to HCP Site

You are now leaving
CUVITRU.com

You are being directed to another website.

Continue Return to CUVITRU.com