GLASSIA- .alpha.1-proteinase inhibitor human injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN (UNII: F43I396OIS) (.ALPHA.1-PROTEINASE INHIBITOR HUMAN - UNII:F43I396OIS)

Disponible depuis:

Takeda Pharmaceuticals America, Inc.

DCI (Dénomination commune internationale):

.ALPHA.1-PROTEINASE INHIBITOR HUMAN

Composition:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN 1 g in 50 mL

Mode d'administration:

INTRAVENOUS

indications thérapeutiques:

GLASSIA is an Alpha1 -Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1 -PI, also known as alpha1 -antitrypsin (AAT) deficiency. Limitations of Use : - The effect of augmentation therapy with GLASSIA or any Alpha1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. - GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1 -PI deficiency has not been established. GLASSIA is contraindicated in: - immunoglobulin A (IgA) deficient patients with antibodies against IgA. - individuals with a history of anaphylaxis or other severe systemic reaction to Alpha1 -PI products. Risk Summar

Descriptif du produit:

Each carton of GLASSIA contains a single-dose vial containing approximately 1 gram of functional Alpha1 -PI in 50 mL of solution (NDC 0944-2884-01).

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

GLASSIA- .ALPHA.1-PROTEINASE INHIBITOR HUMAN INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLASSIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLASSIA.
GLASSIA (ALPHA -PROTEINASE INHIBITOR (HUMAN))
INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Indications and Usage, Increase serum levels of Alpha -PI (1)
9/2023
INDICATIONS AND USAGE
GLASSIA is an Alpha -Proteinase Inhibitor (Human) (Alpha -PI)
indicated for chronic augmentation and
maintenance therapy in adults with clinically evident emphysema due to
severe hereditary deficiency of
Alpha -PI (alpha -antitrypsin deficiency). (1)
Limitations of Use:
The effect of augmentation therapy with any Alpha -PI, including
GLASSIA, on pulmonary exacerbations
and on the progression of emphysema in alpha -antitrypsin deficiency
has not been conclusively
demonstrated in randomized, controlled clinical trials. (1)
Clinical data demonstrating the long-term effects of chronic
augmentation and maintenance therapy of
individuals with GLASSIA are not available. (1)
GLASSIA is not indicated as therapy for lung disease in patients in
whom severe Alpha -PI deficiency
has not been established. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY. (2)
Dose = 60 mg/kg body weight intravenously once weekly. (2.1)
Administer at a rate not to exceed 0.2 mL/kg body weight per minute,
depending on patient response
and comfort. (2.3)
Dose ranging studies using efficacy endpoints have not been performed.
(2.1)
Always use a 5 micron in-line filter (minimum filter diameter of 32 mm
to ensure optimal performance,
not supplied) during infusion. (2.3)
If adverse events occur, reduce the rate or interrupt the infusion
until the symptoms subside. Resume
the infusion at a rate tolerated by the patient. (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: Approximately 1 gram of functional Alpha -PI in 50 mL
of ready to use solution