Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 April 2017

Indication(s)

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)

Full Prescribing information

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Advisory information

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)
Special warnings and precautions

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.


• 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)

Usage information

Dosing 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) x 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)

Interactions

Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, rubella, and varicella. (7)

More information

Category Value
Authorisation number BLA125596
Orphan designation No
Product NDC 0944-2850
Date First Approved 18-10-2016
Marketing authorisation holder Baxalta US Inc.