ABOUT CUVITRU OVERVIEW
Learn about how CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution can help your adult and pediatric (2 years and older) patients—from efficacy to safety and tolerability to product information.1
CUVITRU delivers the protection your PI patients deserve1
In the North American clinical study†:
- The annual rate of acute serious bacterial infections (ASBIs) was 0.012 per patient-year (upper limit of 99% CI: 0.024)‡
- The annual rate of any infections was 2.41 per patient-year (95% CI: 1.89 to 3.03)
†The North American study was a prospective, open-label, non-controlled, multi-center 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 ASBIs, which was evaluated in 74 patients for a median treatment duration of 380.5 days (range, 30-629 days).
‡One ASBI that occurred during the study was a case of pneumonia in a 78-year-old patient.
CUVITRU allows you to customize your patients’ treatment without compromising on tolerability1,2
CUVITRU demonstrated a low rate of local adverse reactions (ARs)—even at higher infusion rates and increased volume per site. In the NA clinical study, the overall rate of local ARs (excluding infections) during the clinical trial was 0.022 ARs per infusion.Learn more about safety & tolerability
CUVITRU is an option for your pediatric patients1
CUVITRU’s administration plans can fit the needs of children 2 and older and their caregivers. Patients weighing <40kg will infuse at ≤20 mL/site for the first 2 infusions. If the initial infusions are well tolerated then subsequent infusions can use the maximum tolerated rate up to 60 mL/hr/site.Learn about CUVITRU in pediatrics
- CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
- 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.