Help your patients with PI reconnect

Patients with PI taking CUVITRU may be able to experience more of these moments with weekly or every-other-week infusions.¹

CUVITRU^® can be infused at the fastest rates or highest volumes with the fewest needlesticks of any SCIG, without sacrificing tolerability^1,2

How fast?

The median duration of once-weekly infusions was <1 hour (0.95 hours; range: 0.2-6.4 hours) in the North American clinical study.

CUVITRU may allow delivery of a full week’s dose in <15 minutes–with even shorter durations possible with more frequent dosing*
Approximately 94% of infusions were completed within 2 hours³
Infuse at rates up to 60 mL/h/site in up to 4 sites simultaneously for a maximum total of 240 mL/h. Infuse first 2 infusions at 10 to 20 mL/h/site

^*If a patient is 75 kg (165 lb) and has been prescribed 36 g of IVIG per month, you could switch your patient to 12 g of CUVITRU weekly. After the first 2 infusions, subsequent infusions of CUVITRU could be completed in 15 minutes at a rate of 60 mL/h/site using 4 sites simultaneously.

What did this mean to patients?

Infuse at volumes up to 60 mL/site in up to 4 sites simultaneously for a maximum volume of 240 mL/h. Infuse first 2 infusions at 10 to 20 mL/h/site
With the highest infusion volume^† (60 mL/h/site, as tolerated) compared to any other conventional SCIG option, a daily, weekly, or every-other-week infusion schedule is possible for your patients
Your patients can create a treatment plan that meets their schedule

How few?

84.9% (N=4314) of infusions were administered using only 1 or 2 infusion sites (18.5%=1 site; 66.4%=2 sites) in the North American clinical study.

Infuse weekly in <1 hour in 1-2 sites
The use of more infusion sites may be beneficial for patients who want to reduce the volume administered per site or overall infusion duration

Well-tolerated administration¹: 98.2% (4247/4327) of infusions had no local ARs—and local tolerability remained the same, even at higher volumes and rates. 2 of 3 patients had no local ARs, such as pain, erythema, and pruritus. The most common ARs overall were local ARs and systemic ARs including headache, nausea, fatigue, diarrhea, and vomiting.

SCIG=subcutaneous immune globulin.

Flexible treatment schedules could mean more time for yoga

Getting started with CUVITRU

To see important information for starting your patients on CUVITRU, explore the tabs below.

Infusion Calculator

Explore administration combinations

Use the infusion calculator to determine CUVITRU administration parameter combinations for your patients based on needlesticks and frequency of infusions, and help your patients achieve CUVITRU’s maximum infusion rate by selecting the proper supplies.

Infusion calculator

Choose from the following parameters to find the right dosing plan for you and your patient.

Monthly
SCIG dose

Dosing
schedule

Infusion
time

Needlesticks	1	2	3	4
CUVITRU

Dosing
volume

per SCIG
20% infusion

The dosing calculator is meant to be used as a tool to help HCPs make informed decisions about dosing. Takeda is not making dosing recommendations.

CUVITRU: Maximum volume per site is 60 mL/site as tolerated (except for the first 2 infusions for patients <40 kg, for whom the maximum volume is 20 mL/site). Maximum infusion rate is 60mL/h/site as tolerated (after first 2 infusions). Up to 4 sites can be used simultaneously.¹

Dosing Calculator

What is the patient's weight?

What is the dose schedule?

Dose calculation of CUVITRU*

Monthly dose	Dose per infusion
300 mg/kg
400 mg/kg
500 mg/kg
600 mg/kg

^*Monthly dose of CUVITRU is equivalent to current monthly dose of SCIG.

Current monthly dose of IVIG/HyQvia

Monthly dose

300 mg/kg

400 mg/kg

500 mg/kg

600 mg/kg

Dose calculation of CUVITRU^†

Current monthly dose of IVIG/HyQvia	Dose calculation of CUVITRU^†
Monthly dose	Monthly dose	Dose per infusion
300 mg/kg	390 mg/kg
400 mg/kg	520 mg/kg
500 mg/kg	650 mg/kg
600 mg/kg	780 mg/kg

For more information about HyQvia, please see Full Prescribing Information

^†Monthly dose of CUVITRU is calculated based on a dose adjustment factor of 1.30.

This calculator does not represent every possible weight calculation. Weights begin as 24 lb and increase in 4 lb increments to 288 lb.

See Full Prescribing Information for additional dosage recommendations. A conversion factor of 2.2046 lb/kg is used to convert the patient’s weight to kilograms. The values displayed are rounded to the nearest decimal point.

Select CUVITRU vial combinations based on dosage

CUVITRU is available in 1 g, 2 g, 4 g, 8 g, and 10 g vials of IG 20%. The dose must be rounded up or down, based on the physician’s clinical judgement.

Infusion Experience

View examples of 2 patients’ infusion sites from pre-infusion to 24 hours after.

Volume infused per physician guidance based on patient’s speciﬁc clinical condition. It may be different for other patients. Infuse first 2 infusions at 10 to 20 mL/h/site.

Patient No. 1: Male, age 59

60 mL infusion in 1 site of the abdomen
Infused at maximum rate of 60 mL/h/site
60-minute infusion

Abdomen of male patient before CUVITRU infusion.

Abdomen of male patient right after CUVITRU infusion.

Abdomen of male patient 4 hours after CUVITRU infusion.

Abdomen of male patient 24 hours after CUVITRU infusion.

Pre-infusion

Immediately following infusion

4 hrs

24 hrs

Patient No. 2: Female, age 14

40 mL infusion in 1 site of the thigh
Infused at rate of 40 mL/h/site
60-minute infusion

Leg of female patient before CUVITRU infusion.

Leg of female patient right after CUVITRU infusion.

Leg of female patient 4 hours after CUVITRU infusion.

Leg of female patient 24 hours after CUVITRU infusion.

Pre-infusion

Immediately following infusion

4 hrs

24 hrs

The most common adverse reactions observed in clinical trials in ≥5% of patients were local adverse reactions including mild or moderate pain, erythemia, and pruritus.

Beginning patients on CUVITRU in a few steps

Learn about starting patients on CUVITRU

Learn more

Pediatrics

Starting Patients

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. 2015.

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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).

Please click for Full Prescribing Information.