CUVITRU (immune globulin subcutaneous- human injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Takeda Pharmaceuticals America, Inc.

INN (Tên quốc tế):

HUMAN IMMUNOGLOBULIN G

Thành phần:

HUMAN IMMUNOGLOBULIN G 1 g in 5 mL

Tuyến hành chính:

SUBCUTANEOUS

Chỉ dẫn điều trị:

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two 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 immunodeficiencies1,2 . - CUVITRU is contraindicated in patients who have had an anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin. - CUVITRU is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human immune 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 CUVITRU. It is also not known whether CUVITRU can cause fetal harm when administered to a pregnant woman or can affect r

Tóm tắt sản phẩm:

How Supplied CUVITRU is supplied in single-dose 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: Storage and Handling

Tình trạng ủy quyền:

Biologic Licensing Application

Đặc tính sản phẩm

CUVITRU- IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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.
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)
In