CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.
CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution is approved for use as replacement therapy for PI in pediatric patients ≥2 years.
CUVITRU clinical studies information
North American clinical study1
CUVITRU was studied in 77 patients (≥2 years of age) with PI in a prospective, open-label, non-controlled, multi-center study. Efficacy was determined in 53 adults aged >16 years, 6 adolescents aged 12 to <16 years, and 15 children aged 2 to <12 years. The primary outcome measure was the annualized rate of ASBIs. For the overall efficacy population (N=74), the annualized ASBI rate was 0.012 (upper limit of 99% CI: 0.024) during CUVITRU treatment. Median treatment duration was 380.5 days (range, 30-629 days).
North American clinical study post-hoc analysis1,2
Select secondary efficacy endpoints were analyzed in 21 pediatric patients from the NA clinical study.
European clinical study1
CUVITRU was studied in 48 patients (≥2 years of age) with PI in a prospective, open-label, non-controlled, multi-center study. The primary outcome measure was the annualized rate of ASBIs. For the overall efficacy population (N=45; 23 pediatric patients 2-18 years old), the annualized ASBI rate was 0.022 (upper limit of 99% CI: 0.049) during CUVITRU treatment. One ASBI of pneumonia was reported in a 12-year-old patient with X-Linked Agammaglobulinemia. Median treatment duration was 358 days (range, 127-399 days).
Pooled North American and European pediatric post-hoc analysis3
Infusion parameters and tolerability were analyzed in 50 pediatric patients (2-17 years old) from the NA and European clinical studies.
There are known risk factors to consider with Cuvitru. Review the full safety information, including contraindications and specific warnings and precautions to take when monitoring patients with Cuvitru.
See Safety InformationWith CUVITRU, children with PI can have the protection they deserve. In the NA clinical study, no pediatric patients experienced an ASBI (acute serious bacterial infection)—and in the post-hoc analysis of the study there were ≤2 infections,* <2 days off of school,† and no hospitalizations‡ per patient-year1,2
In the post-hoc analysis of pediatric patients (N=50) pooled from the NA and EU clinical studies, more than 99% of CUVITRU infusions (N=2624) did not require any rate reduction, interruption, or discontinuation due to ARs3
Whether your pediatric patients prefer faster infusion rates or fewer needlesticks, CUVITRU allows for individualized treatment.1 In the pooled post-hoc analysis, the median infusion time was 56 minutes (range, 18-210 minutes)3
In the pooled post-hoc analysis, 93.7% of CUVITRU infusions were completed with no local ARs, even at higher infusion rates and increased volume per site. No serious or severe ARs related to CUVITRU were reported. The most common ARs (≥4% of patients) were infusion site pain, erythema, pruritus, swelling, headache, and fatigue3
CUVITRU offers a unique infusion profile that makes biweekly (every 2 weeks) administration a reality for your pediatric patients. Regardless of infusion frequency, it delivers steady-state Ig levels1,4
*There were no infections per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61). In patients 5 to <12 years, there were 1.72 infections per patient-year (95% CI, 0.85-3.05), and in patients 12 to <16 years, there were 2.00 infections per patient-year (95% CI, 0.70-4.35).
†There were no days off of school per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61). In patients 5 to <12 years, there were 0.96 days missed (95% CI, 0.35-2.06), and in patients 12 to <16 years, there were 1.86 days missed (95% CI, 0.21-6.61).
‡There were no hospitalizations per patient-year in patients aged 2 to <5 years (95% CI, 0.00-4.61), patients aged 5 to <12 years (95% CI, 0.00-0.32), and patients aged 12 to <16 years (95% CI, 0.00-0.66).
How subcutaneous needles compare to intravenous needles
Ig replacement therapy can be administered subcutaneously like CUVITRU or intravenously like several other Ig treatments.5
Subcutaneous (or “subQ”) administration1,5
Intravenous (or “IVIg”) administration5
Needle sizes may vary. Graphics are for illustrative purposes only.
Hadlie Jo’s doctor customized her administration regimen to help fit her lifestyle
With CUVITRU, Hadlie Jo transitioned from 1 needlestick and a 2.5-hour infusion time every week to 2 needlesticks and a less than 1-hour infusion every 2 weeks—so she could spend less time infusing and more time doing what she loves.
“I like that it’s every other week instead of every week, so I can play or dance or whatever I want to do.”
-Hadlie Jo, 9-year-old PI patient
Actual PI patient. Results represent one patient’s experience. Individual results may vary. Patients should consult their physician as needed.
Get the full details of Hadlie Jo's treatment with
CUVITRU as well as 2 other adult patient case studies.