Safety and Tolerability

Demonstrated tolerability with low rates of systemic adverse reactions and low incidence of local adverse reactions (ARs)1

Tilde sign in front of the number 7 and X.

The systemic AR rate was ~7 times lower than that of IVIG

(0.042 ARs per CUVITRU infusion vs 0.302 ARs per IVIG infusion)

Number 98.2 and the percent sign.

98.2% (4247/4327) of infusions had no local ARs such as pain, erythema, and pruritus in the North American clinical study

  • The most common ARs (in ≥5% of patients) were local ARs and systemic ARs including headache, nausea, fatigue, diarrhea, and vomiting
  • 2 of 3 patients had no local ARs
  • 100% of those ARs 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)
  • Of the 278 nonserious adverse reactions (excluding infections), 83% (231/278) were rated as mild, 16% (45/278) were rated as moderate, and 1% (2/278, hemoptysis and abdominal pain) were severe

Click to see Study Design.

Number 99.8 and the percent sign.

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

  • No patients discontinued due to local ARs
  • 0 serious ARs related to CUVITRU were reported
  • 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 2 severe ARs were not deemed to be causally related to CUVITRU

Safety data was collected, as it occurred, continuously throughout the study.2

*ARs can be defined as serious and nonserious, with the nonserious being mild, moderate, or severe.3 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.

Adverse reactions* in ≥5% of subjects

Adverse reactions

By subject

n (%) 
(N=74 patients)

By infusion

n (rate)
(N=4327 infusions)

Local adverse reactions23 (31.1%)96 (0.022)
Systemic adverse reactions41 (55.4%)182 (0.042)
Headache10 (13.5%)50 (0.012)
Nausea9 (12.2%)16 (0.004)
Fatigue6 (8.1%)9 (0.002)
Diarrhea5 (6.8%)5 (0.001)
Vomiting4 (5.4%)5 (0.001)

Click to see Study Design.

*Defined as adverse events occurring during or within 72 hours of infusion or any causally related event during the study period, excluding infections.

Number and percentages of affected subjects.

Rate = Total number of adverse reactions divided by the total number of infusions under treatment.

Your patients deserve demonstrated tolerability.

Local tolerability remained the same even at higher volumes and rates2 *

Local adverse reactions by infusion rate and volume in the North American clinical study

Local ARs by infusion volume per site

Bar graph depicting local ARs by infusion volume per site.

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

Local ARs by infusion rate per site

Bar graph depicting local ARs by infusion rate per site.

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

North American clinical study1: CUVITRU was studied in 77 patients (≥2 years of age) with PI in a prospective, open-label, noncontrolled, multicenter 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 acute serious bacterial infections (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).

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.

With a concentration of ≥98% IgG,* CUVITRU delivers the purity your patients with PI should expect in a SCIG

CUVITRU product characteristics include1,4,5:

No sugar icon.


Osmolality icon.

Osmolality similar to that of a physiological plasma

No sodium added icon.

No sodium added

pH drop icon.

pH measured at 4.6-5.1

No polysorbate 80 icon.

No polysorbate 80

Amino acid icon.

Uses the simplest naturally occurring amino acid, glycine, as a stabilizer. No L-proline or maltose

SCIG=subcutaneous immune globulin.

*The average immunoglobulin A (IgA) concentration is 80 mcg/mL.

Per the FDA, purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances.6

Polysorbate 80 is used in the manufacturing process in the virus deactivation/removal step, but is removed from the final formulation to undetectable levels.

Studied in pediatric patients

See the efficacy results from the NA study.


  1. CUVITRU. Prescribing information. Baxalta US Inc.; 2021.
  2. 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.
  3. Data on file. Takeda US Inc. 2013.
  4. Shah MM, Mandiga P. Physiology, plasma osmolality and oncotic pressure. Accessed March 7, 2022.
  5. PubChem. Glycine. Accessed April 19, 2022.
  6. US Food and Drug Administration. CFR - Code of Federal Regulations Title 21. Accessed February 21, 2022.