CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
Patients with primary immunodeficiency (PI) taking CUVITRU® may be able to experience more of these moments, with weekly or every-other-week infusions.1
*Upper limit of 99% CI, 0.024; P<0.0001; 1 ASBI occurred.
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
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.
*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.
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
See Study Design.
†Infuse first 2 infusions at 10 to 20 mL/h/site.
SCIG=subcutaneous immune globulin.
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 Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.
Talk to a representative about CUVITRU.
References