XENLETA- lefamulin acetate injection, solution CITRIC BUFFERED NORMAL SALINE- anhydrous citric acid injection, solution XENLET

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LEFAMULIN ACETATE (UNII: HDN0B924X4) (LEFAMULIN - UNII:21904A5386)

Fáanlegur frá:

Nabriva Therapeutics US, Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Legionella pneumophila , Mycoplasma pneumoniae , and Chlamydophila pneumoniae . To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. XENLETA Table

Vörulýsing:

XENLETA is supplied in the following strengths and package configurations: XENLETA Injection How Supplied XENLETA Injection is a clear, colorless, sterile, nonpyrogenic solution for intravenous administration containing 150 mg of lefamulin in 15 mL 0.9% sodium chloride in a single-dose vial intended for dilution in 250 mL of 10 mM citrate buffered (pH 5) 0.9% sodium chloride. The drug product is provided in a clear type I glass 15 mL vial with a gray rubber stopper, aluminum seal and flip off cap. The diluent is provided in infusion bags containing 250 mL of sterile, nonpyrogenic 10 mM citrate buffered (pH 5) 0.9% sodium chloride solution. The vial stopper and infusion bag are not made with natural rubber latex. They are supplied as follows: 150 mg single dose lefamulin vials (NDC 72000-120-06); packed in cartons of 6. 250 mL citrate buffer diluent bags (NDC 72000-030-06); packed in cartons of 6. Storage and Handling XENLETA Injection should be stored at 2°C to 8°C (36°F to 46°F). Store in a refrigerator. Do not freeze. The diluent bags should be stored in barrier overwrap at 2°C to 25°C (36°F to 77°F) until ready to use. [see Dosage and Administration (2.5)] . XENLETA Tablets How Supplied XENLETA Tablets are available as blue, oval, film-coated tablets containing 600 mg lefamulin. The tablets are printed with ‘LEF 600’ in black on one side. They are supplied as follows: Child-resistant blister cards of 10 tablets (NDC 72000-110-10). HDPE bottles of 30 tablets with Child-resistant Closure (NDC 72000-110-30). Storage and Handling XENLETA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Leyfisstaða:

New Drug Application

Vara einkenni

XENLETA- LEFAMULIN ACETATE INJECTION, SOLUTION
CITRIC BUFFERED NORMAL SALINE- ANHYDROUS CITRIC ACID INJECTION,
SOLUTION
XENLETA- LEFAMULIN ACETATE TABLET, COATED
NABRIVA THERAPEUTICS US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XENLETA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XENLETA.
XENLETA (LEFAMULIN) INJECTION, FOR INTRAVENOUS USE
XENLETA (LEFAMULIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
XENLETA is a pleuromutilin antibacterial indicated for the treatment
of adults with community-acquired
bacterial pneumonia (CABP) caused by susceptible microorganisms. (1.1)
To reduce the development of drug resistant bacteria and maintain the
effectiveness of XENLETA and
other antibacterial drugs, XENLETA should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. (1.2)
DOSAGE AND ADMINISTRATION
For treatment of adults with CABP, the recommended dosage of XENLETA
is as follows:
*With the option to switch to XENLETA Tablets 600 mg every 12 hours to
complete the treatment course.
DOSAGE
TREATMENT DURATION
150 mg every 12 hours by intravenous infusion over 60
minutes* (2.1)
5 to 7 days
600 mg orally every 12 hours.(2.1)
5 days
Patients with Hepatic Impairment: Reduce the dosage of XENLETA
Injection to 150 mg infused over 60
minutes every 24 hours in patients with severe hepatic impairment
(Child-Pugh Class C). XENLETA
Tablets have not been studied in and are not recommended for patients
with moderate (Child-Pugh
Class B) or severe hepatic impairment (2.2).
Administration Instruction for XENLETA Tablets: Take at least 1 hour
before a meal or 2 hours after a
meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). (2.3)
Administration Instruction for XENLETA Injection: Infuse over 60
minutes. (2.3)
See Full Prescribing Information for additional information on the
administration and preparation of
XENLETA Tablets and Injection. (2.4)
DOSA