SAFETY & TOLERABILITY
In the North American Study CUVITRU was associated with a low incidence of local adverse reactions (ARs), regardless of infusion rate or volume per site. 2 of every 3 patients (N=51/74) had no local ARs. Overall rate of local ARs (excluding infections) was 0.022 ARs per infusion (0.021 mild and 0.002 moderate).1,2
Adverse reactionsa in ≥5% of subjects associated with infusions of CUVITRU1
|23 (31.1%)||96 (0.022)|
|41 (55.4%)||182 (0.042)|
|Headache||10 (13.5%)||50 (0.012)|
|Nausea||9 (12.2%)||16 (0.004)|
|Fatigue||6 (8.1%)||9 (0.002)|
|Diarrhea||5 (6.8%)||5 (0.001)|
|Vomiting||4 (5.4%)||5 (0.001)|
aDefined as adverse events occurring during or within 72 hours of infusion or any causally related event during the study period, excluding infections.
bNumber and percentages of affected subjects.
cRate = Total number of adverse reactions divided by the total number of infusions under treatment.
CUVITRU administration was well-tolerated2
98.2% (N=4327) of infusions had no local
ARs such as pain, erythema, and pruritus1,2
2 of every 3 patients had no local ARs1
- 100% of those local ARs that were reported were mild† (92.5%) or moderate† (7.5%) in severity
- The overall rate of local ARs (excluding infections) was 0.022 ARs per infusion (0.021 mild* and 0.002 moderate*)
- The most common local ARs reported in ≥5% of patients were pain (20.3%), erythema (10.8%), and pruritus (5.4%)
- No patients discontinued due to local ARs
99.8% of infusions were completed without a reduction,
interruption, or discontinuation due to tolerability in the North American clinical study1,2
- 0 serious† 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 ≥5% of patients were 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.3
Safety data was collected, as it occurred, continuously throughout the study.2
*CUVITRU can be infused up to 60 mL/site, as tolerated. During the first 2 infusions for patients ≤40 kg, the maximum volume is 20 mL/site and the maximum rate is 20 mL/hr per site.
Even at increased rates and volumes, there was no increase in local ARs2
Local adverse reactions by infusion rate and volume in the North American Clinical Study
Only infusions with complete infusion history (N=4314) have been considered for these analyses. Overall, 71.6% of patients achieved a maximum infusion rate of 60 mL/h/site at least once.2
Safety data were collected, as they occurred, continously throughout the study1,2
- Investigators instructed the patient/caregiver regarding identification and documentation of local and systemic adverse events (AEs)
- All patients received an eDiary tablet to continuously record home treatments, AEs, and additional information
- Patients were followed up with either a diary system or by the investigator within 3 to 5 days after each infusion, to ensure appropriate documentation of AEs
- Every 8-12 weeks, investigators recorded AEs that occurred during the infusions at the site
- Patients’ eDiary entries were reviewed by the investigator at every site visit
- All reported AEs were assessed by investigators for seriousness, severity, temporal association, and possible causal relatedness to the investigational product
All patients were required to be on a stable dose of IVIG or SCIG for at least 12 weeks prior to enrollment in the study2
Nearly 70% of patients enrolled were naïve to SCIG (68.8% IVIG; 31.2% SCIG)2
Patients were not premedicated for SCIG infusions unless an AR of at least moderate severity occurred and did not resolve with infusion rate reduction during or after SCIG infusions.
CUVITRU offers patients
- 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.
- Data on file. Takeda US Inc. 2013.