CUVITRU [Immune Globulin Subcutaneous (Human)] 20% Solution puts you and your patient in charge of treating PI.

Dosing Parameters

Customize administration to your patient's individual needs and preferences*

Individualize each patient's dose by monitoring pharmacokinetic and clinical response, as well as IgG trough levels, making dose adjustments as needed.
Number of Infusion Sites

Number of Infusion Sites

CUVITRU can be infused at volumes up to 60 mL (12 g), per site, in 1 to 4 sites simultaneously.1 84.9% of infusions were administered using only 1 or 2 infusion sites.1 The rate of local adverse reactions was not associated with increased volume per site.1,4
Volume Per Site

Volume Per Site

To calculate the number of sites to be used, divide the total volume to be infused by the maximum volume/site (up to 60 mL/site) to be infused. Simultaneous subcutaneous infusion at multiple sites can be facilitated by use of a multi-needle administration set. For the first 2 infusions of CUVITRU, the recommended infusion rate is 10-20 mL/h/site. For subsequent infusions, the infusion rate may be increased to 60 mL/h/site, as tolerated (eg, 60 mL/h/site x 2 sites = 120 mL/h).1
Infusion Rate

Infusion Rate

CUVITRU can be infused at a rate of up to 60 mL per hour, per site.1 The median duration of weekly infusions was less than 1 hour.1 The rate of local adverse reactions was not associated with increased rate of infusion.1,4 For patients utilizing 4 infusion sites, the maximum infusion rate for all sites combined is 240 mL/h.1
Frequency of Dosing

Frequency of Dosing

CUVITRU can be administered at regular intervals from daily up to every 2 weeks (biweekly).1

CUVITRU was well tolerated, with a low incidence of local adverse reactions (0.042 reactions/infusion), regardless of infusion rate or volume per site1,4

Treatment Initiation

Getting started with CUVITRU

Selecting the right dose for your patient
When getting started with CUVITRU, dose determination varies based on whether patients are switching from IVIG treatment, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution, or other SCIG treatments.
Patients who are:

Switching from IVIG treatment or HYQVIA1

Treatment with CUVITRU should begin 1 week after the patient's last IVIG or HYQVIA infusion.

Establish the initial weekly dose by converting the monthly IVIG or HYQVIA dose into an equivalent weekly dose and increasing it using a dose adjustment factor (1.30).

Initial weekly dose
=

Previous IGIV or HYQVIA dose (in grams)

Number of weeks between IGIV or HYQVIA doses

x1.30

Switching from SCIG treatment1

The initial weekly dose is recommended to be the same as the weekly dose of the prior SCIG treatment.

divide the calculated weekly dose by the desired frequency per week Regardless of prior IG treatment history, if the desire is to dose CUVITRU more frequently than once weekly, divide the calculated weekly dose by the desired frequency per week1
If the desired frequency is biweekly, multiply the weekly dose by two If the desired frequency is biweekly, multiply the weekly dose by two1
Multiply the calculated dose by 5 to convert from grams to milliliters Multiply the calculated dose by 5 to convert from grams to milliliters1
Getting your patient up to speed
The rate of infusion and volume per site should be increased based on each individual patient's needs, preferences, and ability to tolerate treatment.1

Infusion Volume and Rate*1

Infusion Parameters First 2 Infusions Subsequent Infusions
  Patients <40kg Patients ≥40kg Patients <40kg Patients ≥40kg
Volume (mL/site) ≤20 ≤60 ≤60
Rate (mL/h/site) 10-20 ≤60

*If the initial infusions are well tolerated, then subsequent infusions can be administered at the maximum tolerated rate.

Personalizing the overall dose

Individualize each patient’s dose by monitoring pharmacokinetic and clinical response, as well as IgG trough levels, making dose adjustments as needed.1

Personalizing the overall dose of CUVITRU Personalizing the overall dose of CUVITRU Personalizing the overall dose of CUVITRU

Change in Volume to Be Administered Weekly/Biweekly for Intended IgG Trough Level Change1a

Body Weight
Difference from Target Serum IgG Trough Levels   Dosing Frequency 30 kg 50 kg 70 kg 90 kg 110 kg
100 mg/dL   Weekly 3 mL 5 mL 7 mL 9 mL 11 mL
    Biweekly 6 mL 10 mL 13 mL 17 mL 21 mL
200 mg/dL   Weekly 6 mL 10 mL 13 mL 17 mL 21 mL
    Biweekly 12 mL 19 mL 27 mL 35 mL 42 mL
300 mg/dL Weekly 9 mL 14 mL 20 mL 26 mL 32 mL
    Biweekly 17 mL 29 mL 40 mL 52 mL 63 mL

aDerived using a linear approximation of trough levels and weekly dose per kg body mass with a slope of 52.1 kg/dL.

If the difference between measured and target trough levels is less than 100 mg/dL, then no adjustment is necessary.1

The patient's clinical response should be the primary consideration in dose adjustment1

CUVITRU Administration

See how CUVITRU dosing can be customized to your patient's needs

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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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