Help your patients with
demonstrated tolerability

Low rates of systemic adverse reactions (ARs) vs IVIG and low incidence of local ARs¹

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
The most common systemic ARs (in ≥5% of patients) were headache, nausea, fatigue, diarrhea, and vomiting

98.2% (4247/4327) of infusions had no local ARs such as pain, erythema, and pruritus

2 of 3 (n=51/74) 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)
The most common local ARs (in ≥5% of patients) were pain, erythema, and pruritus

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Demonstrated tolerability

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)*

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.

IVIG=intravenous immune globulin.

Adverse reactions* in ≥5% of subjects¹

Adverse reactions	By subject n (%)^† (N=74 patients)	By infusion n (rate)^‡ (N=4327 infusions)
Local adverse reactions	23 (31.1%)	96 (0.022)
Systemic adverse reactions	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)

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.

How do your patients tolerate infusions?

CUVITRU demonstrated tolerability at higher infusion volumes and rates with a low number of causally related local ARs^2*

Comparison of CUVITRU infusions

With causally related local ARs

Without causally related local ARs

By infusion site volume

By rate of infusion per site

Out of the total number of CUVITRU infusions (per infusion volume and maximum infusion rate), a low number of infusions had causally related local ARs.

Local tolerability of CUVITRU remained the same even at higher volumes and rates.²

24 out of 1880 infusions of CUVITRU had local ARs related to CUVITRU at infusion volumes per site between 40-59 mL

9 out of 2480 infusions of CUVITRU had local ARs related to CUVITRU at maximum infusion rates per site of ≥60 mL/h

*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).

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Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.

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With a concentration of ≥98% IgG,^* CUVITRU delivers the purity^† your patients with PI should expect in a SCIG¹

CUVITRU product characteristics include^1,4,5:

Sugar-free

Osmolality similar to that of a physiological plasma

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

pH measured at 4.6-5.1

No polysorbate 80^‡

No sodium added

^*The average immunoglobulin A (IgA) concentration is 80 mcg/mL.¹

^†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.

SCIG=subcutaneous immune globulin.

Studied in pediatric patients

See the efficacy results from the CUVITRU pediatric studies.

Explore data for pediatrics

Efficacy

Pediatrics

References

CUVITRU. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc.; 2023.
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.
Shah MM, Mandiga P. Physiology, plasma osmolality and oncotic pressure. Accessed January 5, 2023. https://www.ncbi.nlm.nih.gov/books/NBK544365/
PubChem. Glycine. Accessed January 5, 2023. https://pubchem.ncbi.nlm.nih.gov/compound/Glycine
US Food and Drug Administration. CFR - Code of Federal Regulations Title 21. Accessed January 5, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=600.3

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IMPORTANT SAFETY INFORMATION including BOXED WARNING for Thrombosis

INDICATION

CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS

Thrombosis may occur with immune globulin (IG) products, including CUVITRU. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
For patients at risk of thrombosis, administer CUVITRU at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Contraindications

History of anaphylactic or severe systemic hypersensitivity reactions to subcutaneous administration of human IG.
IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human IG.

Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur with intravenous (IV) use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to starting infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: CUVITRU contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because CUVITRU is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with CUVITRU.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

Adverse Reactions

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.

Drug Interactions

Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

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