Learn about a PI treatment that provides protection against infection—on their terms.

Why CUVITRU

CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution treatment can be customized to meet your patient’s individual needs and preferences

Beyond lifestyle and individual goals, people with PI can vary widely in terms of their clinical presentation, their type and degree of immunological deficit, and their ability to tolerate specific immune globulin (IG) treatments.2,3

CUVITRU allows for individualized IG administration—without compromising the tolerability or efficacy of the product—so you and your patient can have control over these factors1:
CUVITRU number of infusion logonumber of infusion sites
CUVITRU volume per site logovolume per site
The rate of infusions for CUVITRU logoinfusion rate
The frequency of infusions for CUVITRU logofrequency of infusions

CUVITRU was infused at a volume of up to 60 mL per site and at a rate of up to 60 mL per hour, per site, without impacting local tolerability1,4

How CUVITRU was studied

CUVITRU was evaluated in the North America Study, a prospective, open-label, non-controlled, multi-center trial to determine the efficacy, safety, tolerability, and pharmacokinetics of CUVITRU in 77 adult and pediatric subjects (≥2 years of age) with PI. The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBIs), which was evaluated in 74 patients for a median treatment duration of 380.5 days.1

Efficacy

No matter how they choose to self-infuse, know they have the protection they deserve

CUVITRU provides the reliable protection against infection that your patients with PI need

In the North American Study, the annual rate of acute serious bacterial infections (ASBIs) was 0.012 per patient-year, significantly lower than the threshold of 1.0 per patient-year (upper limit of 99% CI: 0.024; p<0.0001).1

1 ASBI occurred during use of CUVITRU1 ASBI occurred
Rate of hospitalization logo: 0.06 days per patient-year hospitalized with CUVITRU0.06 days in hospital per patient-year
  • The rate of hospitalizations due to infections was 0.012 per patient-year (95% CI: 0.006 to 0.022)
  • The annual rate of any infections was 2.41 per patient-year (95% CI: 1.89 to 3.03)
  • CUVITRU treatment delivers consistent IgG levels at steady-state
CUVITRU helps minimize the impact of PI on your patients’ daily lives
  • Patients treated with CUVITRU experienced 1.16 days per patient-year during which they were unable to perform normal daily activities due to illness or infection, such as attending work or school (1.16 days per patient-year; 95% CI: 0.70 to 1.79)1

CUVITRU was shown to significantly improve patient quality of life in terms of convenience (TSQM-9*; p<0.001) and treatment interference (LQI; p=0.008) when compared to intravenous immune globulin (IVIG) treatment1

  • *TSQM=Treatment Satisfaction Questionnaire for Medication.
  • LQI=Life Quality Index.

Safety & Tolerability

Customize their treatment without compromising on tolerability

The local tolerability of CUVITRU remained the same, even when it was dosed at higher volumes per site, so you can customize with confidence1,4

  • CUVITRU was associated with a low incidence of local adverse reactions (ARs), regardless of infusion rate or volume per site1,4
    • The overall rate of local ARs (excluding infections) during the clinical trial was 0.022 ARs per infusion (0.021 mild* and 0.002 moderate*)
    • Local AR rates did not increase with increasing volumes or rates of infusion1,4

Safety data were collected, as they occurred, continuously throughout the study1,4

Methods are summarized in 6 key pointsShow +
  • All patients were required to be on a stable dose of IVIG or SCIG for at least 12 weeks prior to enrollment in the study4
  • Nearly 70% of patients enrolled were naive to SCIG (68.8% IVIG; 31.2% SCIG)4

Adverse Reactionsa in ≥5% of Subjects Associated with Infusions of CUVITRU1

Adverse Reactions By Subject N (%)b (N=74 Subjects) By Infusion N (Rate)c (N=4372 Subjects)
Local Adverse Reactions 23 (31.1%) 96 (0.022)
Pain 15 (20.3%) 36 (0.008)
Erythema 8 (10.8%) 23 (0.005)
Pruritus 4 (5.4%) 8 (0.002)
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)
  • aExcluding infections.
  • bNumber and percentages of affected subjects.
  • cRate = Total number of adverse reactions divided by the total number of infusions under treatment.
Tolerability of CUVITRU
CUVITRU administration logo: 2 out of every 3 patients had no local adverse reactions2 out of every 3 patients had no local adverse reactions1
  • No local ARs were observed in 68.9% of patients and in 98.2% of infusions (median duration of treatment: 380.5 days; range: 30-629 days)1
    • 100% of those local ARs that were reported were mild* (92.5%) or moderate* (7.5%) in severity1
  • 0 serious ARs related to CUVITRU were reported1
  • Of the 278 non-serious 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*1
    • The 2 severe ARs were not deemed to be causally related to CUVITRU4
Percentage logo: 99.8% of infusions completed without reduction, interruption, or discontinuation due to tolerability reasons99.8% of infusions were completed without a reduction, interruption, or discontinuation due to tolerability reasons1
Low rate logo: CUVITRU demonstrated a low rate of systemic ARs (0.042 reactions/infusion)CUVITRU demonstrated a low rate of systemic ARs (0.042 reactions/infusion)1

The systemic adverse reaction rate was ≈7x lower than that of IVIG1

  • As seen in the CUVITRU clinical study (0.042 systemic ARs/infusion of CUVITRU vs 0.302 systemic ARs/infusion IVIG)1
  • *ARs can be defined as serious, and non-serious with the non-serious being mild, moderate, or severe. Mild ARs are defined as transient discomfort that resolves spontaneously or with minimal intervention. Moderate ARs are defined as those that cause limited impairment of function, may require therapeutic intervention, and produce no sequelae. Severe ARs are defined as those that 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.5
  • Serious ARs are defined as those that result in death, are life-threatening, require or prolong hospitalization, result in persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect.5

Customizable Administration

CUVITRU can help you find the right balance in your patient's IG treatment experience

CUVITRU lets you and your patients choose the number of infusion sites1

  • CUVITRU can be infused weekly, in < 1 hour, in 1 to 2 sites
  • In the clinical study, 84.9% of infusions were administered using only 1 or 2 infusion sites (18.5% = 1 site; 66.4% = 2 sites)
  • Patients have the ability to infuse up to 60 mL per site, at up to 4 infusion sites simultaneously
  • The use of more infusion sites may be beneficial for patients who want to reduce the volume administered per site or overall treatment duration
CUVITRU allows patients to infuse at a customizable rate1
CUVITRU can be infused:
Rate logo: CUVITRU can be infused at rates up to 60 mL (12 g) per hour, per site...at rates up to 60 mL (12 g) per hour, per site...
CUVITRU number of infusion logo...at up to 4 sites simultaneously...
Rate per hour logo: CUVITRU can be infused for a maximum total rate of 240 mL per hour...for a maximum total rate of 240 mL per hour
  • In the clinical study, the median duration of once-weekly infusions was less than 1 hour (0.95 hours; range: 0.2-6.4 hours)1
  • For patients looking to minimize infusion time, CUVITRU allows for delivery of a full week’s dose in under 15 minutes—with even shorter durations possible with more frequent dosing1
    • For example, if a patient is 165 lbs and was prescribed 36g of IVIG per month, you could switch your patient to CUVITRU 12g weekly. After the first 2 infusions, subsequent infusions of CUVITRU could be completed in 15 minutes at a rate of 60 mL/hour/site using 4 sites simultaneously

CUVITRU was associated with a low incidence of local ARs (0.042 reactions/infusion), regardless of infusion rate or volume1,4

The CUVITRU dosing schedule can be tailored to your patient's unique lifestyle1
  • CUVITRU maintains similar IG exposure at regular dosing intervals, from daily to up to once every 2 weeks1

Patients who had previously received IVIG reported that CUVITRU fit better into their schedules and was more convenient than IV infusion1

Product Information

How CUVITRU is supplied

Image of CUVITRU [Immune Globulin Subcutaneous (Human)] 20% solution dosing options: 1.0 g protein, 2.0 g protein, 4.0 g protein, 8.0 g protein

CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution is supplied in single-use vials containing the labeled amount of functionally active IgG. The components used in the packaging for CUVITRU are not made with natural rubber latex.

The following presentations of CUVITRU are available:

NDC Number Volume Gram Protein
0944-2850-01 5 mL 1.0
0944-2850-03 10 mL 2.0
0944-2850-05 20 mL 4.0
0944-2850-07 40 mL 8.0
Storage and Handling
  • Store at refrigeration temperature: 2°C to 8°C (36°F to 46°F) for up to 36 months, or room temperature:
    not to exceed 25°C (77°F) for up to 12 months
  • Do not return CUVITRU to the refrigerator if you take it out to room temperature
  • Do not freeze or shake
  • Keep the vials in the carton in order to protect from light
  • Do not use past the expiration date, and discard any unused product

CUVITRU is formulated with no added sugars, no added sodium, no preservatives, and no proline or sucrose stabilizers.

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Please expand for Indication and Important Safety Information.

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.

Please read below for Indication and Important Safety
Information for CUVITRU.

Please click for Full Prescribing Information, including Boxed Warning regarding 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.

To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report suspected adverse reactions, contact Shire Drug Safety at 1-800-999-1785 or drugsafety@shire.com.

If you have a medical or clinical question regarding the use of CUVITRU [Immune Globulin Subcutaneous (Human)] 20%, please contact Shire Medical Information at 1-866-424-6724 or medinfoUS@shire.com.

References: 1. CUVITRU [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. Bousfiha A, Jeddane L, Al-Herz W, et al. The 2015 IUIS phenotypic classification for primary immunodeficiencies. J Clin Immunol. 2015;35(8):727-738. doi:10.1007/s10875-015-0198-5. Epub October 7, 2015. 3. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146-160. 4. 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). DOI 10.1007/s10875-016-0327-9. 5. Data on file. Shire US Inc. Feb 2013. 6. U.S. Food and Drug Administration. User fee billable biologic products and potencies approved under section 351 of the PHS Act. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122936.htm. Accessed 28 July 2016.

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