Help your patients with PI

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Patients with primary immunodeficiency (PI) taking CUVITRU® may be able to experience more of these moments, with weekly or every-other-week infusions.1

In the North American clinical study1:


0.012 acute serious bacterial infections*
(annual rate per patient/year)


99.8% of infusions completed without interruptions

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Help your patients get access to CUVITRU

The North American study was a prospective, open-label, noncontrolled, multicenter clinical trial to determine the efficacy, safety, tolerability, and pharmacokinetics (PK) of CUVITRU in 77 adult and pediatric patients ≥2 years of age with PI. The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBIs), which was evaluated in 74 patients for a median treatment duration of 380.5 days (range, 30–629 days). The annual rate of ASBIs was 0.012 per patient-year (upper limit of 99% CI: 0.024), which is significantly lower (P<0.0001) than the threshold of 1.0 per patient-year and provides substantial evidence of efficacy.1

*Upper limit of 99% CI, 0.024; P<0.0001; 1 ASBI occurred.

Proven protection against infection1

In the North American clinical study:

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The annual rate of acute serious bacterial infections
(ASBIs) was 0.012 (upper limit of 99% CI, 0.024;
P<0.0001*) per patient-year

  • 1 ASBI occurred
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The annual rate of infections of any kind was
2.41 (95% CI: 1.89-3.03) per patient year

*Significantly lower than the threshold of 1.0 per patient-year which provides substantial evidence of efficacy.1

Pneumonia was reported in a 78-year-old patient who had a specific antibody deficiency and allergic bronchopulmonary aspergillosis. 

CI=confidence interval.

CUVITRU was shown to significantly improve patient quality of life vs IVIG1 

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In terms of convenience (TSQM-9*) 

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In terms of treatment interference (LQI*) 

Treatment satisfaction was measured using the Life Quality Index questionnaire (LQI) and the Treatment Satisfaction Questionnaire for Medication (TSQM-9). The LQI was assessed for the age group 2 years to 12 years (observer: parent) and the age group 13 years and older (observer: subject) in 3 domains: Treatment Interference, Therapy-Related Problems, and Therapy Settings. The TSQM-9 was assessed in subjects aged 2 to 12 years (observer: parent) and 13 years and older (observer: subject) in 3 domains: Effectiveness, Convenience, and Global Satisfaction. Differences between scores during the intravenous study part and subcutaneous 20% study part were calculated for selected domains of the instruments.1

*TSQM-9, P<0.001; LQI, P=0.008. Both TSQM-9 and LQI were assessed in patients aged 2 to 12 (with a parent observer), and in patients aged ≥13 (with the patient as the observer).

IVIG=intravenous immune globulin; LQI=Life Quality Index; TSQM=Treatment Satisfaction Questionnaire for Medication.

Demonstrated tolerability

In the North American clinical study1:

99.8 percent.

99.8% of infusions were completed without a reduction, interruption, or discontinuation due to tolerability

  • No patients discontinued due to local adverse reactions (ARs)
  • 0 serious ARs related to CUVITRU were reported
Tilde in front of 7x.

The systemic AR rate was ~7 times lower than IVIG

  • 0.042 ARs per CUVITRU infusion vs 0.302 ARs per IVIG infusion

Of the 278 nonserious 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 most common adverse reactions observed in clinical trials in ≥5% of patients were: local adverse reactions including mild or moderate pain, erythema, and pruritus, and systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.

ARs can be defined as serious and non-serious, with the non-serious being mild, moderate, or severe. Mild: transient discomfort that resolves spontaneously or with minimal intervention. Moderate: cause limited impairment of function, may require therapeutic intervention, do not interfere significantly with the subject’s normal functioning level, and produce no sequelae. Severe: result in marked impairment of function that may lead to temporary inability to resume usual life pattern and/or produces sequelae which require (prolonged) therapeutic intervention.2

A SCIG with flexible dosing and administration1,3

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Fastest infusion rates

<1 hour (0.95 hours; range: 0.2-6.4 hours) was the
median duration of once-weekly infusions in the
North American study1

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Highest SCIG infusion volumes*

60 mL/site is the highest volume compared to
any other conventional SCIG option1,3

&#34;1 - 2 sites&#34; inside of a circle.

Fewest needlesticks

Only 1 or 2 infusion sites (18.5%=1 site;
66.4%=2 sites) were used in 84.9% of infusions
(N=4314) administered in the North American
clinical study1

Infuse first 2 infusions at 10 to 20 mL/h/site.

SCIG=subcutaneous immune globulin.

Unrestricted access to CUVITRU

Find local coverage for CUVITRU

Use this lookup tool to determine your patient’s coverage details for CUVITRU. Search for local coverage by entering a ZIP code and selecting both CUVITRU and the channel type.

Review safety information

Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.

Get answers to your questions

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  1. CUVITRU. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2023.
  2. Data on File. Takeda US Inc. 2013.
  3. 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.