EBANGA- ansuvimab kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ANSUVIMAB (UNII: TG8IQ19NG2) (ANSUVIMAB - UNII:TG8IQ19NG2)

Disponível em:

Ridgeback Biotherapeutics, LP

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

EBANGA is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration (2.2) and Clinical Studies (14)] . Limitations of Use: The efficacy of EBANGA has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use EBANGA. None . Risk Summary Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (

Resumo do produto:

How Supplied EBANGA (ansuvimab-zykl) for injection is supplied as a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial (NDC 80673-001-01) for reconstitution and further dilution. One primary carton (NDC 80673-001-36) contains thirty-six 400 mg vials packaged in a box containing either one primary carton (NDC 80673-777-01), four primary cartons (NDC 80673-777-04), or eight primary cartons (NDC 80673-777-08). Storage and Handling Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake. Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes. If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours. After reconstitution, if storage is needed, the entire storage time for the reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours refrigerated at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2)] . The expiration date for the product is available via a product-specific website with frequent update. The Quick Response (QR) Code at the end of this leaflet is scannable via mobile phone and will direct the user to the EBANGA website. Users will be asked to register for authorized access to lot- specific information via the Lot No. printed on the box containing one, four, or eight 36-vial carton(s). Please access the website using the QR code provided. Alternatively, please go to: www.EBANGA.com . Do not use EBANGA beyond the expiration date available via this website.

Status de autorização:

Biologic Licensing Application

Características técnicas

EBANGA- ANSUVIMAB
RIDGEBACK BIOTHERAPEUTICS, LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EBANGA™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EBANGA.
EBANGA (ANSUVIMAB-ZYKL) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
EBANGA™ (ansuvimab-zykl) is a _Zaire ebolavirus _glycoprotein (EBOV
GP)-directed human monoclonal
antibody indicated for the treatment of infection caused by _Zaire
ebolavirus _in adult and pediatric patients,
including neonates born to a mother who is RT-PCR positive for _Zaire
ebolavirus _infection. ( 1)
Limitation of Use
The efficacy of EBANGA has not been established for other species of
the _Ebolavirus_ and _Marburgvirus_
genera _._
_Zaire ebolavirus _can change over time, and factors such as emergence
of resistance or changes in viral
virulence could diminish the clinical benefit of antiviral drugs.
Consider available information on drug
susceptibility patterns for circulating _Zaire ebolavirus _strains
when deciding whether to use EBANGA.
DOSAGE AND ADMINISTRATION
The recommended dose of EBANGA for adult and pediatric patients is 50
mg/kg reconstituted, further
diluted, and administered as a single intravenous infusion over 60
minutes. ( 2.1, 2.2)
See Full Prescribing Information for instructions on preparation,
dilution and administration of EBANGA
injection. ( 2.2)
DOSAGE FORMS AND STRENGTHS
For injection: 400 mg lyophilized powder in a single-dose vial for
reconstitution and further dilution. ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Infusion-Associated Events:
Hypersensitivity reactions including
infusion-associated events have been reported with EBANGA. These may
include acute, life-threatening
reactions during and after the infusion. Monitor patients and in the
case of severe or life-threatening
hypersensitivity reactions, discontinue the administration of EBANGA
immediately and administer
appropriate