Description

Lefamulin 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 Lefamulin and other antibacterial drugs, Lefamulin 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.

lefamulin Injection: Strong or moderate CYP3A inducers or P-gp inducers: Avoid lefamulin unless the benefit outweighs the risk. Monitor for reduced efficacy. lefamulin Tablets Strong or moderate CYP3A inducers or P-gp inducers: Avoid lefamulin unless the benefit outweighs the risk. Monitor for reduced efficacy. Strong CYP3A inhibitors or P-gp inhibitors: Avoid lefamulin. Moderate CYP3A inhibitors or P-gp inhibitors: Monitor for adverse reactions. CYP3A substrates that prolong the QT interval: Concomitant use is contraindicated. Midazolam and other sensitive CYP3A substrates: Monitor for adverse reactions.

Lefamulin Injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache. Lefamulin Tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation.

Based on findings from animal studies, Lefamulin may cause fetal harm when administered to pregnant women. There are no available data on the use of Lefamulin in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are no data on the presence of Lefamulin in human milk, its effects on the breastfed infant, or its effects on milk production.

QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile-associated Diarrhea (CDAD): Evaluate patients who develop diarrhea.

Other antibacterial preparation

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.