The oral and intravenous (IV) formulations of Xenleta (lefamulin), a first-in-class pleuromutilin antibiotic, have been made available in the US by Nabriva Therapeutics.

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.

Xenleta is supplied as 600mg tablets and as 150mg/15mL single-dose vials. Xenleta Injection must be diluted with the diluent supplied before administration by IV infusion. Clinicians may initiate CABP treatment with either formulation; patients treated with the IV formulation may be switched to the oral tablets to complete their treatment course if clinically indicated.

Xenlata Tablets are not recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. As for the IV formulation, dose reduction is recommended for patients with severe hepatic impairment; however, no dosage adjustment is needed in patients with mild or moderate impairment.

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“Xenleta is now available to healthcare providers for the treatment of CABP patients in the hospital, during transition from the hospital to home, and for patients in the ambulatory care setting,” said Francesco Maria Lavino, Nabriva’s Chief Commercial Officer. 

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