Lefamulin

507.73

507.73

White to off-white

J01XX|J - Antiinfectives for systemic use

1.19±0.1 g/cm3(Predicted)

618.6±55.0 °C(Predicted)

14.45±0.60(Predicted)

2-8°C

WGK 3

|Warning|H371 (100%): May cause damage to organs [Warning Specific target organ toxicity, single exposure]|P260, P264, P270, P309+P311, P405, and P501|The GHS information provided by 1 company from 1 notification to the ECHA C&L Inventory.

Serum ALT, AST and GGT elevations above 3 times the upper limit of normal occurred in 1.2% to 3.5% of patients treated with lefamulin (n=641), but rates and severity of serum enzyme elevations were similar to those in comparator arms (moxifloxacin: n=641). These enzymes elevations were usually mild-to-moderate in severity, self-limited in duration and not accompanied by symptoms or jaundice. Instances of clinically apparent liver injury attributable to lefamulin have not been reported but this antibiotic has had limited general use.

Treatment of community-acquired pneumonia|Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Lefamulin is a new and relatively unique antibiotic used for treatment of community acquired pneumonia. Lefamulin has not been linked to an increased rate of transient serum liver test abnormalities during treatment or to instances of clinically apparent liver injury.

Antiinfective Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

BC-3781

Human Drugs -> EU pediatric investigation plans|Human drugs -> Xenleta -> EMA Drug Category|Antibacterials for systemic use -> Human pharmacotherapeutic group|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients