CUTAQUIG- immunoglobulin g solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

Available from:

Octapharma USA Inc

Administration route:

SUBCUTANEOUS

Therapeutic indications:

CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. CUTAQUIG is contraindicated: - In patients who have had an anaphylactic or severe systemic reaction to the subcutaneous administration of human immune globulin or to any of the components of CUTAQUIG such as Polysorbate 80. - In IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human globulin treatment. Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with CUTAQUIG. It is not known whether CUTAQUIG can cause fet

Product summary:

CUTAQUIG is supplied in 1 g, 1.65 g, 2 g, 3.3 g, 4 g or 8 g single-use vials.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CUTAQUIG- IMMUNOGLOBULIN G SOLUTION
OCTAPHARMA USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CUTAQUIG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CUTAQUIG.
CUTAQUIG® (IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) - HIPP),
16.5% SOLUTION
INITIAL U.S. APPROVAL: 2018
WARNING: THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
CUTAQUIG. 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 CUTAQUIG 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
Indications and Usage ( 1 ) 10/2021
Dosage and Administration, Dose ( 2.1 ) 10/2021
Dosage and Administration, Administration ( 2.3 ) 10/2021
INDICATIONS AND USAGE
CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5%
immune globulin solution for
subcutaneous infusion indicated for treatment of primary humoral
immunodeficiency (PI) in adults and
pediatric patients 2 years of age and older. ( 1 )
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS USE ONLY
Before switching to CUTAQUIG, obtain the patient’s serum IgG trough
level to guide subsequent dose
adjustments.
DOSE ( 2.1 )
• Switching from Immune Globulin Intravenous (IGIV) to CUTAQUIG:
calculate the dosing by using a dose
conversion factor (1.30); Switching from other Immune Globulin
Subcutaneous (IGSC): dosing should be
the same as for previous IGSC.
• Weekly : Start CUTAQUIG one week after last IGIV infusion
Initial weekly dose = Previous IGIV dose (in grams) x 1.30
No. of weeks between IGIV doses
• Every other week :