For: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).CUVITRU 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 Grams 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
0944-2850-09 50 mL 10.0
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 24 months.
Do not return CUVITRU to the refrigerator if you take it out to room temperature.
Do not freeze.
Do not shake.
Keep the vials in the carton in order to protect from light.
Discard any unused product.
Do not use past the expiration date.
These highlights do not include all the information needed to use CUVITRU safely and effectively. See full prescribing information for CUVITRU.
CUVITRU, Immune Globulin Subcutaneous (Human), 20% Solution
Initial U.S. Approval: 2016
WARNING: THROMBOSIS
See full prescribing information for complete boxed warning
Thrombosis may occur with immune globulin 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.
RECENT MAJOR CHANGES
Dosage and Administration (2)
6/2018
INDICATIONS AND USAGE
CUVITRU is an Immune Globulin Subcutaneous (Human), 20% solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous infusion only.
Administer at regular intervals from daily up to every two weeks (biweekly). (2.2)
Individualize dose based on the patient's pharmacokinetic and clinical response. (2.2)
Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed. (2.2)
Switching from Immune Globulin Intravenous (Human) treatment (IGIV) or adult patients switching from HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]:
Begin treatment one week after the patient's last IGIV or HYQVIA infusion. (2.2)
Establish initial weekly dose by converting the monthly IGIV or HYQVIA dose into equivalent weekly dose and increasing it using a dose adjustment factor. (2.2)
Initial Weekly dose = Previous IGIVor HYQVIA dose (in grams) � 1.30
No. of weeks between IGIVor HYQVIA doses.
Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week. (2.2)
Biweekly dosing: Multiply the calculated weekly dose by 2. (2.2)
Switching from Immune Globulin Subcutaneous (Human) treatment (IGSC):
Weekly dose (in grams) should be the same as the weekly dose of prior IGSC treatment (in grams). (2.2)
Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week. (2.2)
Biweekly dosing: Multiply the calculated weekly dose by 2. (2.2)
Infusion sites: up to 4 infusion sites simultaneously, with at least 4 inches between sites avoiding bony prominences. Rotate sites with each administration. (2.3)
DOSAGE FORMS AND STRENGTHS
200 mg/mL (20%) protein solution for subcutaneous infusion (3)
CONTRAINDICATIONS
Anaphylactic or severe systemic hypersensitivity reactions to subcutaneous administration of Immune Globulin (Human). (4)
IgA deficient patients with antibodies against IgA and a history of hypersensitivity. (4)
WARNINGS AND PRECAUTIONS
IgA deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reaction. (5.1)
Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. (5.2)
Thrombosis may occur. Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity. (5.3)
Aseptic Meningitis Syndrome (AMS) may occur. (5.4)
Monitor for clinical signs and symptoms of hemolysis. (5.5)
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI). (5.6)
Product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease agent. (5.7)
ADVERSE REACTIONS
The most common adverse reactions observed in ?5% of patients were: local adverse reactions, systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, rubella, and varicella. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019