ZINPLAVA- bezlotoxumab injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

bezlotoxumab (UNII: 4H5YMK1H2E) (bezlotoxumab - UNII:4H5YMK1H2E)

제공처:

Merck Sharp & Dohme LLC

INN (국제 이름):

bezlotoxumab

구성:

bezlotoxumab 25 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

ZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. [See Dosage and Administration (2.1).] None. Risk Summary Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Risk Summary There is no information regarding the presence of bezlotoxumab in human m

제품 요약:

ZINPLAVA Injection: is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution and is supplied in the following packaging configuration: Carton (NDC 0006-3025-00) containing one (1) single-dose vial of ZINPLAVA 1,000 mg/40 mL (25 mg/mL). Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze. Do Not Shake.

승인 상태:

Biologic Licensing Application

제품 특성 요약

ZINPLAVA- BEZLOTOXUMAB INJECTION, SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZINPLAVA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZINPLAVA.
ZINPLAVA™ (BEZLOTOXUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Indications and Usage (1)
5/2023
Dosage and Administration, Dosing Recommendations in Adults and
Pediatric
Patients 1 year of age and older (2.2)
5/2023
INDICATIONS AND USAGE
ZINPLAVA is a human monoclonal antibody that binds to _Clostridioides
difficile_ toxin B, indicated to reduce
recurrence of _Clostridioides difficile_ infection (CDI) in adults and
pediatric patients 1 year of age and older
who are receiving antibacterial drug treatment for CDI and are at a
high risk for CDI recurrence. (1)
Limitation of Use:
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an
antibacterial drug. ZINPLAVA
should only be used in conjunction with antibacterial drug treatment
of CDI. (1)
DOSAGE AND ADMINISTRATION
Administer ZINPLAVA during antibacterial drug treatment for CDI. (2.1)
The recommended dose is a single dose of 10 mg/kg administered as an
intravenous infusion over 60
minutes. (2.2)
Dilute prior to intravenous infusion. Administer via a low-protein
binding 0.2 micron to 5 micron in-line or
add-on filter. See Full Prescribing Information for dilution and
administration instructions. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
(3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Heart Failure: Was reported more commonly in ZINPLAVA-treated patients
with a history of congestive
heart failure (CHF) in Trial 1 and Trial 2. In patients with a history
of CHF, ZINPLAVA should be reserved for
use when the benefit outweighs the risk. (5.1)
ADVERSE REACTIONS
Adult Patients: The most common adverse reactions (reported in ≥4%
of adult patients) included
nausea, pyrexia, and headache. (6.