RAXIBACUMAB injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

RAXIBACUMAB (UNII: 794PGL549S) (RAXIBACUMAB - UNII:794PGL549S)

Saatavilla:

Emergent Manufacturing Operations Baltimore LLC

INN (Kansainvälinen yleisnimi):

RAXIBACUMAB

Koostumus:

RAXIBACUMAB 50 mg in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. Raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. It is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax [see Clinical Studies (14.1)]. Safety and pharmacokinetics (PK) of raxibacumab have been studied in adult healthy volunteers. There have been no trials of safety or PK of raxibacumab in the pediatric population. An extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults [see Use in Specific Populations (8.4)]. Raxibacumab binds to the protective antigen (PA) of B.

Tuoteyhteenveto:

Raxibacumab is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution supplied in single-use vials containing 1,700 mg/34 mL (50 mg/mL) raxibacumab and is available in the following packaging configuration: Single Unit Carton: Contains one single-use vial of raxibacumab 1,700 mg/34 mL (NDC 71655-103-01). Raxibacumab must be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Protect the vial from exposure to light, prior to use. Brief exposure to light, as with normal use, is acceptable. Store vial in original carton until time of use.

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

RAXIBACUMAB- RAXIBACUMAB INJECTION
EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAXIBACUMAB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAXIBACUMAB.
RAXIBACUMAB INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
WARNING: HYPERSENSITIVITY AND ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
RECENT MAJOR CHANGES
Boxed Warning
Warnings and Precaution, Hypersensitivity and Anaphylaxis (5.1)
5/2021
5/2021
INDICATIONS AND USAGE
Raxibacumab is indicated for the treatment of adult and pediatric
patients with inhalational anthrax due to
_Bacillus anthracis_ in combination with appropriate antibacterial
drugs, and for prophylaxis of inhalational
anthrax when alternative therapies are not available or are not
appropriate. (1.1)
Limitations of Use:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 1,700 mg/34 mL (50 mg/mL) solution in a single-use vial.
(3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity and Anaphylaxis: (Boxed Warning, 2.1, 2.3, 5.1, 6.1)
ADVERSE REACTIONS
Common adverse reactions in healthy adult subjects (≥1.5%) were
injection site reaction, erythema and
pain, headache, rash, pain in extremity, pruritus, and somnolence.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EMERGENT BIOSOLUTIONS
AT 1-800-768-
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS, HAVE BEEN REPORTED
DURING OR
AFTER THE ADMINISTRATION OF RAXIBACUMAB BY INTRAVENOUS INFUSION (5.1).
ADMINISTER RAXIBACUMAB BY INTRAVENOUS INFUSION IN MONITORED SETTINGS
WHERE
APPROPRIATE EQUIPMENT, MEDICATION (INCLUDING EPINEPHRINE) AND
PERSONNEL TRAINED
IN THE MANAGEMENT OF HYPERSENSITIVITY, ANAPHYLAXIS, AND SHOCK ARE
AVAILABLE (2.3,
5.1).
The effectiveness of raxibacumab is based solely on efficacy studies
in animal models of inhalational
anthrax. (1.2, 14.1)
There have been no studies of raxibacumab in the pediatric pop